Use Of ADT Research Articles

CARDIOVASCULAR MANIFESTATIONS AFTER AMITRIPTYLINE POISONING IN THE LAST FIVE YEARS

Tricyclic antidepressants (TCAs) were introduced in the 1950s for the treatment of depression. In adults, TCAs are used to treat depression, migraine headache prophylaxis, neuralgic pain, including pain associated with cigarette poisoning, and obsessive-compulsive disorder. Despite the current limited use of ADT, hospitalizations and deaths associated with ADT use are increasing. Therefore, this work sought to verify the profile of amitriptyline poisoning in the last five years through articles downloaded from the Web of Science database - all databases - between the years 2019 and 2023. According to the results, TCA toxicity can mainly induce cardiovascular manifestations, leading to respiratory depression, sinus tachycardia, or even more dangerous tachydysrhythmias and even bradycardia with or without heart block. These findings indicate that TCA toxicity can be fatal, and this information is of great importance to facilitate understanding and appropriate management by health professionals involved in the care of patients with depression and other diseases that require the use of amitriptyline.

Unraveling the safety of adjuvant radiotherapy in prostate cancer: impact of older age and hypofractionated regimens on acute and late toxicity - a multicenter comprehensive analysis.

The objective of this study was to assess the impact of age and other patient and treatment characteristics on toxicity in prostate cancer patients receiving adjuvant radiotherapy (RT). This observational study (ICAROS-1) evaluated both acute (RTOG) and late (RTOG/EORTC) toxicity. Patient- (age; Charlson's comorbidity index) and treatment-related characteristics (nodal irradiation; previous TURP; use, type, and duration of ADT, RT fractionation and technique, image-guidance systems, EQD2 delivered to the prostate bed and pelvic nodes) were recorded and analyzed. A total of 381 patients were enrolled. The median EQD2 to the prostate bed (α/β=1.5) was 71.4 Gy. The majority of patients (75.4%) were treated with intensity-modulated radiation therapy (IMRT) or volumetric-modulated arc therapy (VMAT). Acute G3 gastrointestinal (GI) and genitourinary (GU) toxicity rates were 0.5% and 1.3%, respectively. No patients experienced >G3 acute toxicity. The multivariable analysis of acute toxicity (binomial logistic regression) showed a statistically significant association between older age (> 65) and decreased odds of G≥2 GI acute toxicity (OR: 0.569; 95%CI: 0.329-0.973; p: 0.040) and decreased odds of G≥2 GU acute toxicity (OR: 0.956; 95%CI: 0.918-0.996; p: 0.031). The 5-year late toxicity-free survival rates for G≥3 GI and GU toxicity were 98.1% and 94.5%, respectively. The only significant correlation found (Cox's regression model) was a reduced risk of late GI toxicity in patients undergoing hypofractionation (HR: 0.38; 95% CI: 0.18-0.78; p: 0.008). The unexpected results of this analysis could be explained by a "response shift bias" concerning the protective effect of older age and by treatment in later periods (using IMRT/VMAT) concerning the favorable effect of hypofractionation. However, overall, the study suggests that age should not be a reason to avoid adjuvant RT and that the latter is well-tolerated even with moderately hypofractionated regimens.

Online Correction of Intrafraction Motion during Volumetric Modulated Arc Therapy for Prostate Radiotherapy: A Cohort Study Quantifying the Frequency of Shifts and Analysis of Men at Highest Risk.

We have previously described our early experience using fiducial markers to correct for intrafraction motion during radiation therapy (RT) to the prostate using the TrueBeam Advanced imaging package. We sought to further characterize the utility of this approach in a larger cohort, and analyze factors associated with intrafraction motion. A total of 132 men with fiducial markers treated with RT for intact prostate cancer at a single center were treated with a VMAT technique using 2-3 arcs. All patients underwent planning CT after a rectal enema and same day placement of 3 fiducial markers (Gold Anchor). Triggered kV images were acquired every 10 seconds using an onboard imaging system. Intrafraction motion correction was considered if any two fiducial markers were observed beyond a 3 mm tolerance margin. A manual 2D-3D match was performed using the fiducial markers from the single triggered kV image to obtain a couch shift. Shift data were extracted from the record and verify system and expressed as a single 3-dimensional translation. Shift percent was defined as the number of instances of a >3 mm intrafraction correction divided by the total number of fractions for a given patient. Clinical variables were evaluated, including body mass index, hormone therapy (ADT), prostate, rectal bladder volumes, and rectal width (transverse dimension of rectum at the mid-gland of prostate on simulation CT). Across 2659 fractions, intrafraction motion correction was performed 582 times, in 463 fractions (17%). 101/132 patients (77%) had at least one shift during their treatment course, and 48/132 patients (36%) had shifts with an average magnitude of at least 5 mm. The median shift was 3.6 mm (range, 0-2.4 cm; IQR, 1.5-5.4 mm). 25% of men had a shift percent >20% (SP>20%). Univariate analysis revealed that only larger rectal volume or width, smaller prostate size, and use of ADT were associated with SP>20% (p<0.05). Men with rectal width in the top quartile (>3.6 cm) were more likely to have intrafraction motion corrected with SP>20% (47% vs 18%, p = 0.0016), and similarly men with rectal volume in the top quartile (>112 cc) were more likely to have SP>20% (44% vs 19%, p = 0.0067). On multivariate analysis, only rectal parameters (e.g., top quartile rectal width, HR 3.9, p = 0.0024) were correlated with a higher frequency of intrafraction motion. Intrafraction motion occurs in a significant percentage of men undergoing prostate RT with VMAT, and is correctable utilizing a common feature. On multivariate analysis, rectal volume and width were associated with larger shift percent. Treatment approaches which do not account for intrafraction motion should consider including methods of immobilization, or larger PTV margins in order to avoid marginal miss of the prostate.

Open-label study of darolutamide plus androgen-deprivation therapy (ADT) vs ADT in metastatic hormone-sensitive prostate cancer using an external control arm (ARASEC).

TPS5112 Background: Darolutamide (DARO) is a structurally distinct and highly potent androgen receptor inhibitor. In the phase 3 ARASENS study (NCT02799602) in patients (pts) with metastatic hormone-sensitive prostate cancer (mHSPC), DARO + ADT + docetaxel significantly reduced the risk of death by 32.5% vs ADT + docetaxel (hazard ratio 0.68; 95% confidence interval 0.57–0.80), with a favorable tolerability and safety profile. In the global (excluding US), phase 3 ARANOTE study (NCT04736199), DARO + ADT vs ADT alone is being evaluated in pts with mHSPC. ARASEC (NCT05059236) will complement ARANOTE by assessing DARO + ADT in US pts. As ADT alone is no longer an acceptable comparator in the US, the external control arm will be derived from the historical US CHAARTED study (NCT00309985). A real-world analysis of electronic health record data from pts with mHSPC (TIMES) indicated that there was minimal risk of historical time bias associated with the use of the external ADT alone arm from CHAARTED as a comparator for ARASEC (Shore N, et al . J Clin Oncol 2022;40(28 Suppl):Abstract 403). Methods: ARASEC is a phase 2, open-label, single-arm study enrolling pts with confirmed mHSPC and no prior systemic therapy. Pts will receive DARO 600 mg orally twice daily + ADT (luteinizing hormone-releasing hormone agonist/antagonist or orchiectomy). The external control arm will be derived from 394 pts with mHSPC treated with ADT alone in CHAARTED. To remove biases in evaluating outcomes that could arise due to differences in baseline profiles between arms, pts will be matched 1:1 using a propensity score (PS) summarizing baseline characteristics relevant to disease outcomes. Baseline variables will include age ( &lt; 70 vs ≥70 years), Eastern Cooperative Oncology Group performance status (0–1 vs 2), CHAARTED-defined extent of disease (low vs high volume + bone metastases only vs high volume + visceral metastases ± bone metastases), and prior therapy (yes vs no; as a proxy for recurrent vs de novo disease). Matching patients with scores within a narrow window across the cohorts will ensure that pts in CHAARTED are representative of pts in the DARO + ADT arm. The primary endpoint is progression-free survival (PFS), as defined in CHAARTED. Secondary endpoints include overall survival, radiographic PFS, time to CRPC, undetectable prostate-specific antigen response rate ( &lt; 0.2 ng/mL) at 6 months, and safety. Target enrollment for the DARO + ADT arm is 200 pts at 30 sites. The study will continue until either the event count threshold triggering the primary endpoint analysis has been met (161 PFS events) or all pts have been followed for ≥2 years, whichever occurs later. As of January 2023, 121 pts have been enrolled. A per-protocol, predefined matching exercise on the first 100 pts enrolled will be conducted to ensure that the planned sample size is adequate. Clinical trial information: NCT05059236 .

MP77-16 MANAGEMENT OF BIOCHEMICAL RECURRENCE AND INCIDENT METASTATIC DISEASE AFTER RADICAL PROSTATECTOMY FOR PROSTATE CANCER

You have accessJournal of UrologyCME1 Apr 2023MP77-16 MANAGEMENT OF BIOCHEMICAL RECURRENCE AND INCIDENT METASTATIC DISEASE AFTER RADICAL PROSTATECTOMY FOR PROSTATE CANCER Ted Skolarus, Kristian Stensland, Daniel Herr, David Elliott, Jennifer Burns, Jordan Sparks, Chris Shin, Alexander Zaslavsky, Alexander Tsodikov, and Megan Caram Ted SkolarusTed Skolarus More articles by this author , Kristian StenslandKristian Stensland More articles by this author , Daniel HerrDaniel Herr More articles by this author , David ElliottDavid Elliott More articles by this author , Jennifer BurnsJennifer Burns More articles by this author , Jordan SparksJordan Sparks More articles by this author , Chris ShinChris Shin More articles by this author , Alexander ZaslavskyAlexander Zaslavsky More articles by this author , Alexander TsodikovAlexander Tsodikov More articles by this author , and Megan CaramMegan Caram More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003351.16AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Prostate cancer recurrence after surgery often presents as asymptomatic, biochemically recurrent, non-metastatic castration-sensitive disease. The extent to which the use and timing of ADT in this setting is associated with progression to metastatic disease is largely unknown. For these reasons, we conducted a population-based study to examine associations between biochemical recurrence management and progression along the castration cascade. METHODS: We used national electronic health record, cancer registry, administrative, pharmacy, and laboratory data to conduct a retrospective cohort study of men undergoing radical prostatectomy for localized prostate cancer from 2005 through 2015 in the Veterans Health Administration. We followed men through 2019 for biochemical recurrence, defined as PSA ≥0.2 ng/mL, and incident metastatic disease, identified using a validated natural language processing algorithm. We used multivariable regression to examine associations between metastatic disease and patient, disease, and salvage management approaches including ADT. RESULTS: We identified 8,558 men with biochemical recurrence after radical prostatectomy. Most patients were managed with observation and/or salvage radiation therapy (70%). Metastatic disease occurred in 14% and on univariate analysis was associated with decreased time to biochemical recurrence (15.5 months, metastatic vs. 19.2 months non-metastatic), younger age at recurrence, positive surgical margins, higher pathologic stage and PSA at diagnosis (all p<0.01). Salvage ADT was used in 30% of patients with recurrence, mostly among men who remained non-metastatic (65%). Pre-ADT PSA was higher among men with metastatic disease (4.1 ng/mL metastatic vs. 0.9 ng/mL non-metastatic, p<0.001), as was castration-resistant drug use (48.2% metastatic vs. 4.5% non-metastatic, p<0.001). Salvage ADT was highly associated with metastatic disease in this observational study (adjusted odds ratio 6.04, 95% CI 4.68-7.81). CONCLUSIONS: Management of biochemically recurrent disease after radical prostatectomy varied widely, including the use and timing of ADT. We found metastatic disease occurred in about 1 in 7 men with recurrence and was associated with traditional risk factors. While most salvage ADT was for non-metastatic disease, the extent to which castration use in observational data reflects disease severity or incites castration-resistance and metastatic disease warrants further study. Source of Funding: NCI R01 CA242559 © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e1108 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Ted Skolarus More articles by this author Kristian Stensland More articles by this author Daniel Herr More articles by this author David Elliott More articles by this author Jennifer Burns More articles by this author Jordan Sparks More articles by this author Chris Shin More articles by this author Alexander Zaslavsky More articles by this author Alexander Tsodikov More articles by this author Megan Caram More articles by this author Expand All Advertisement PDF downloadLoading ...

Ability of STAR-CAP staging system to prognosticate risk of subsequent therapies after initial treatment of M0 prostate cancer.

310 Background: Given lower mortality rates and life expectancy loss in prostate cancer, treatment regimens must consider long-term outcomes with quality of life. Aggressiveness of treatment impacts severity of side effects and depends on the highly heterogeneous staging of the disease at onset. Staging and risk-classification systems have been developed, including STAR-CAP staging system which informs prognosis and could help with treatment intensification decisions. Compared with existing models such as the AJCC, STAR-CAP had superior performance and prognostic power for disease mortality prediction. However the risk of requiring subsequent therapies (ie salvage radiation therapy or androgen deprivation therapies after initial treatment) has not been described in STAR-CAP cohorts. Quantifying risk of subsequent therapies after initial therapies is clinically useful to help patients decide between various management strategies and whether monotherapies or multi-modality therapies may be sufficient. Methods: Patients who could be stratified by STAR-CAP system and underwent surgery or radiation therapy were identified from an institutional observational registry. Patients treated before 2010 were gathered retrospectively (n=835) and prospectively thereafter (n=2588). The primary endpoint was progression to additional therapy after primary treatment (radiation, surgery, or systemic therapy). Risk of progression accounting for STAR-CAP group was estimated using the Fine and Gray Competing risk model, with death as the competing risk. P&lt;0.05 was considered statistically significant. Results: 3424 men diagnosed with prostate cancer underwent curative-intent treatment with surgery or radiation therapy (RT) between 1995 – 2022. The median age at diagnosis was 64.9 years (IQR 59.4 to 70.0); median follow-up time was 5.4 years. Patients with STAR-CAP 1A-1C had a statistically similar risk of requiring additional therapies, whereas those with 2A to 3B disease had a significantly and incrementally higher risk of requiring additional therapies (by group, hazard ratios and 95% CI: 2A, 1.8 (1.2 to 2.5); 2B, 2.9 (2.1 to 4.2); 2C, 3.4 (2.4 to 4.9); 3A, 5.7 (3.9 to 8.3); 3B, 7.0 (4.4 to 11.1), all p&lt;0.001). The 5-year risks of requiring additional therapy after surgery for a Stage 1A, 2A, and 3A patient is 9.7%, 16.2%, and 38%, respectively. The 5-year risks of requiring additional therapy after radiation with or without ADT for a Stage 1A, 2A, and 3A patient are 7.3%, 10.4% and 27.9%, respectively. Conclusions: The STAR-CAP grouping system can prognosticate risk of requiring additional therapies after primary treatment of localized prostate cancer. The lower risk of subsequent therapy seen in RT patients is likely due to use of ADT with RT. Using STAR-CAP to prognosticate risk of subsequent therapies after primary treatment can help guide treatment intensification decisions upfront.

Simultaneous integrated boost (SIB) stereotactic body radiotherapy (SBRT) for prostate and pelvic nodes in high risk, node positive and oligometastatic prostate cancers: Safety, efficacy and quality of life outcome measures.

121 Background: SBRT in high risk (HR), node positive (N+) and oligometastatic (OM) prostate cancers is limited by pelvic nodal coverage, larger treatment volumes and use of hormone therapy. We report the safety, efficacy and patient reported quality of life measures (QOL) for SIB-SBRT for prostate and pelvic nodal treatment in HR, N+ and OM (non-regional node or skeletal deposits) cohorts. Methods: 22 patients of NCCN category HR, N+, OM adenocarcinoma prostate and all staged by MRI prostate and PSMA PETCT scan received SIB-SBRT from April 2019 to October 2021. All received long term androgen (ADT) deprivation therapy (80%) or surgical castration (20%). ADT was neo-adjuvant, concomitant and adjuvant for at least 2 years and for OM 2nd generation hormone treatment. SIB-SBRT to prostate and pelvic nodal regions (until common iliac level) was 35-36.25 Gy and 25 Gy in 5 fractions respectively. Post ADT gross PSMA avid nodes and skeletal deposits received 30 Gy in 5 fractions. SIB-SBRT was by volumetric modulated arc therapy (VMAT) with intrafraction imaging and hexapod robotic couch corrections on alternate days. Baseline IPSS and Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP) QOL recorded and then post SIB-SBRT at 6 weeks and then 3 monthly till 2 years. Dosimetry followed standard published literature. Results: 22 patients were treated over 3 years with median age of 70 years. The median PSA at baseline was 45ng/ml with 90% Gleason score 8+. The OM disease included nonregional nodes or 1-2 skeletal deposits. After median follow up of 20 months acute grade 2 genitourinary (GU) and gastrointestinal (GI) toxicities were 10% and 12%, respectively. Late grade 2 GU and GI toxicities were 4% and 9%, respectively. Late grade 3 GU and GI toxicity was seen in 2 patients each requiring medical management. 2- year overall survival and biochemical failure-free survival was 95% and 90% respectively. Baseline median IPSS score was 9 and median EPIC CP score was 12/60. Mean urinary incontinence domain scores worsened significantly from baseline to 6 months and obstructive scores improved from baseline to 6 months with more than 95% patients not using any pads at 6 months. Bowel frequency scores were maximum at 6 weeks post SBRT and it persisted till 6 months. Sexual function scores declined gradually and recovered only in a few at last follow up. Vitality/hormonal scores were unchanged from baseline till 6 months. Conclusions: SIB-SBRT for HR, N+ and OM prostate cancers is safe and effective, with good QOL. The encouraging PSA control and minimal grade 3 toxicity and favorable therapeutic ratio achieved reflect the feasibility of LINAC based SIB-SBRT. This warrants long term follow-up with effective bladder/rectal protocol measures and optimal use of ADT in a prospective setting.

Randomized trial of MRI-guided salvage radiotherapy for prostate cancer in 4 weeks vs. 2 weeks (SHORTER).

TPS400 Background: The objective of this randomized clinical trial is to demonstrate that 2 weeks (5 fractions) of real-time MRI-guided radiotherapy (RT) with an MR Linac does not significantly increase patient-reported GI and GU symptoms compared to 4 weeks (20 fractions) of RT 2 years after treatment completion. Methods: Key Eligibility Criteria: Inclusion Criteria 1. Men aged &gt; 18 with histologically confirmed prostate cancer after prostatectomy with detectable PSA. 2. KPS &gt; 70. 3. Patients with no evidence of distant metastatic disease on PET/CT/MRI/bone scan&lt; 180 days prior to enrollment. 4. Ability to receive MRI-guided radiotherapy. 5. Ability to complete the Expanded Prostate Cancer Index Composite (EPIC) questionnaire. Exclusion Criteria 1. Prior history of receiving pelvic RT. 2. Patient with history of IBD. 3. History of bladder neck or urethral stricture. Study Design/Endpoints: This is a randomized phase II non-inferiority trial comparing 5 fractions of ultrahypofractionated RT (32.5 Gy total with optional PSMA/MRI boost to 40 Gy) versus 20 fractions of hypofractionated RT (55 Gy total with optional PSMA/MRI boost to 60 Gy) in the post-operative setting for prostate cancer. Subjects will be stratified based on pre-specified stratification factors and randomized 1:1 to receive 5 or 20 fractions using permuted block randomization. The primary endpoint is the change in patient-reported GI and GU symptoms as measured by EPIC at 2 years from end of treatment. Secondary endpoints will include both the safety endpoints including change in GI and GU symptoms at 3, 6, 12 and 60 months from end of treatment, and multiple efficacy endpoints including time to progression, prostate cancer specific survival and overall survival. Sample Size: The sample size is calculated based on a non-inferiority design. The non-inferiority margins are set to be a change score of 6 points for the GI symptoms and 5 points for the GU symptoms. The standard deviations of the change scores are assumed to be 13.2 for the GI symptoms and 10.5 for the GU symptoms based on estimates generated in RTOG 0415 trial. This level of change in scores are deemed as clinically meaningful. For example, 6 points of change score for GI symptoms corresponds to two symptoms worsening by 1 level (i.e., loose stools and frequency of bowel movements change from “no problem” to “very small problem”) or one of the symptoms worsening by 2 levels (i.e., loose stool change from “no problem” to “small problem”). A sample size of 122 with 61 in each arm will ensure 80% power for GI endpoint and 83% power for GU endpoint to detect non-inferiority using a one-sided two-sample t-test at the significance level of 0.05. Adjusting for a projected 10% EPIC/non-compliance rate, 136 patients (68 per arm) will be randomized. Stratification Factors: Patients will be stratified according to baseline EPIC bowel and urinary domain scores and use of nodal treatment and ADT. Enrollment: 91 patients. Clinical trial information: NCT04422132 .

Long-Term Outcomes of Stereotactic Body Radiotherapy (SBRT) for Intraprostatic Relapse after Definitive Radiotherapy for Prostate Cancer: Patterns of Failure and Association between Volume of Irradiation and Late Toxicity.

The aim of this retrospective study was to assess the adverse effects and outcomes of salvage re-irradiation with stereotactic body radiotherapy (sSBRT) for local recurrence of prostate cancer (PCa) after definitive radiotherapy (RT). The study was focused on the adverse effects and prognostic factors for treatment toxicity, followed by an analysis of patterns of failure and survival. Patients treated with sSBRT between 2012 and 2020 at a tertiary institution were included. The exclusion criteria were a primary or salvage radical prostatectomy or a palliative sSBRT dose. Patients with oligorecurrence were eligible if all metastatic lesions were treated locally with curative intent. The Kaplan-Meier method was used to estimate time to grade ≥ 3 toxicity, local control (LC), freedom from distant metastases (FFDM), progression-free survival (PFS), biochemical control (BC) and overall survival (OS). The differences between groups (focal vs. whole-gland sSBRT) were compared using the log-rank test. The Cox proportional hazards model was used to assess prognostic factors for the listed endpoints. A total of 56 patients with a median age of 70.9 years and a median follow-up of 38.6 months were included in the analysis. The majority of them received local sSBRT only (45; 80.4%), while the rest were simultaneously treated for oligometastases (11; 19.6%). Overall, 18 (32.1%) patients experienced any grade ≥ 3 toxicity, including 1 (6.7%) patient who received focal sSBRT, and 17 (41.5%) patients treated with whole-gland sSBRT. The Planning Target Volume (per cc; HR 1.01; 95% CI 1-1.02; p = 0.025) and use of ADT (yes vs. no; HR 0.35; 95%CI 0.13-0.93; p = 0.035) were independent prognostic factors for the risk of grade ≥ 3 toxicity. The estimated rate of grade ≥ 3 adverse events was significantly higher (43.8% vs. 7.1% at 2 years; p = 0.006), and there was no improvement in the LC (92.9% vs. 85.3% at 2 years; p = 0.759) in patients treated with whole-gland sSBRT compared to focal sSBRT. The 2- and 5-year LC were 87.6% and 47.9%, respectively; the 2- and 5-year FFDM were 72.7% and 42.8%, respectively; and the 2- and 5-year PFS were 67.9% and 28.7%, respectively. The primary pattern of failure was distant metastasis. The sSBRT for local recurrence of PCa after definitive RT was associated with a high risk of severe grade ≥ 3 toxicity, which significantly increased with the volume and extent of re-irradiation.

Toxicity Outcomes at 18 Months for Cs-131 Low-Dose-Rate Prostate Brachytherapy Compared to I-125 and Pd-103

<h3>Purpose/Objective(s)</h3> Low dose rate prostate brachytherapy is an established component of definitive radiotherapy options for localized prostate cancer. As the utility of LDR brachytherapy (LDRB) has evolved, the focus has shifted to improving the side effect profile while maintaining oncologic outcomes. Most prior efficacy and toxicity data were gathered using I-125 and Pd-103, but due to the shorter half-life and slightly higher average energy of Cs-131, several institutions have adopted its use in an attempt to improve outcomes and decrease toxicity. To report the toxicity outcomes up to 18 months after Cs-131 LDR brachytherapy at our institution, compared to our experience with I-125 and Pd-103. <h3>Materials/Methods</h3> A retrospective review was performed on the first 50 patients treated with Cs-131 LDRB for localized prostate cancer at our institution. Patients receiving either a full or partial implant were included. Prescription doses of 100Gy and 80Gy were utilized, respectively. Patients receiving partial implants generally received 45Gy external beam radiotherapy starting 6-8 weeks after implant. Data regarding AUA prostate symptom score, sexual health inventory for men (SHIM) score, and RTOG GI toxicity score were assessed pretreatment, at 1 month, and at each subsequent follow up. Demographic and clinical data were also collected. The data was compared to cohorts of the last 50 patients treated I-125 and the last 50 patients treated with Pd-103, to standard doses. Descriptive statistics were used to summarize variables. A linear mixed model was used to compare means and to identify variables as prognostic for toxicity (p≤0.05). <h3>Results</h3> The mean AUA scores prior to brachytherapy were similar for patients in all groups (p=1.00), while at 1-month post-treatment, mean AUA score was significantly higher for patients treated with Cs-131 and Pd-103 compared to I-125 (p<0.001). Mean AUA scores were not significantly different at longer follow-up (p>0.50). The need for a catheter post-brachytherapy occurred in 8% of patients and was not associated with type of isotope on multivariate analysis (MVA). Prostate volume, numbers of seeds, and prostate D90% were significant predictors for the need for a catheter on MVA. The use of ADT and the total activity were significant predictors on MVA for a decrease in SHIM score over time. The type of isotope used did not predict for erectile dysfunction (ED) as measured by SHIM score on MVA. Overall rates of GI toxicity were low with only 3 patients developing RTOG grade 2 toxicity or greater without any obvious difference between isotopes. <h3>Conclusion</h3> In patients treated with Cs-131 or Pd-103 LDRB, acute GU side effects peaked higher at 1 month than with I-125, but rapidly decreased to similar levels with longer follow-up. The type of source used did not predict for need for catheterization, ED, or GI toxicity at any time point.

Local Failure after Prostate SBRT Predominantly Occurs in the PI-RADS 4 or 5 Dominant Intraprostatic Lesion

BackgroundA positive post-treatment prostate biopsy following definitive radiotherapy carries significant prognostic implications. ObjectiveTo determine whether local recurrences after prostate stereotactic body radiation therapy (SBRT) are associated with the presence of and occur more commonly within the region of a PI-RADS 4 or 5 dominant intra-prostatic lesion (DIL) identified on pre-treatment multi-parametric magnetic resonance imaging (MRI). Design, Setting, and Participants247 patients with localized prostate cancer treated with SBRT at our institution from 2009–2018 underwent post-treatment biopsies (median time to biopsy: 2.2 years) to evaluate local control. InterventionsProstate SBRT (median 40 Gy in 5 fractions). Outcome Measurements and Statistical AnalysisMRIs were read by a single diagnostic radiologist blinded to other patient characteristics and treatment outcomes. The DIL presence, size, location, and extent were then analyzed to determine associations with the post-treatment biopsy outcomes. Results and LimitationsAmong patients who underwent post-treatment biopsies, 39/247 (15.8%) were positive for Gleason-gradable prostate adenocarcinoma, of which 35/39 (90%) had a DIL initially present and 29/39 (74.4%) had a positive biopsy within the DIL. Factors independently associated with post-treatment biopsy outcomes included the presence of a DIL (OR 6.95; p = 0.001), radiographic T3 disease (OR 5.23, p < 0.001), SBRT dose ≥40 Gy (OR 0.26, p = 0.003), and use of androgen deprivation therapy (ADT; OR 0.28, p = 0.027). Among patients with a DIL (N = 149), the only factors associated with post-treatment biopsy outcomes included ≥50% percent cores positive (OR 2.4, p = 0.037), radiographic T3 disease (OR 4.04, p = 0.001), SBRT dose ≥40 Gy (OR 0.22, p < 0.001), and use of ADT (OR 0.21, p = 0.014). ConclusionsOur results suggest that men with PI-RADS 4 or 5 DILs have a higher risk of local recurrence after prostate SBRT and that most recurrences are located within the DIL. Patient SummaryWe found the presence of a dominant tumor on pre-treatment MRI was strongly associated with residual cancer within the prostate after SBRT and that most recurrences were within the dominant tumor.

Patterns of Failure in Men With Radiorecurrent Prostate Cancer: A Post-Hoc Analysis of Two Prospective Ga-68-PSMA PET/CT Imaging Trials

<h3>Purpose/Objective(s)</h3> The advent of novel nuclear medicine imaging modalities, such as prostate specific membrane antigen positron emission tomography/computed tomography (PSMA PET/CT), has significantly impacted the ability to localize disease in patients with biochemically recurrent prostate cancer (PCa). However, the topography of recurrence in men with radiorecurrent disease remains poorly understood. <h3>Materials/Methods</h3> This was a <b>post-hoc</b> analysis of men from two prospective studies of PSMA PET/CT for radiorecurrent prostate cancer, previously treated with definitive radiotherapy (RT), who had detailed clinicopathologic and treatment characteristics available and at least one PSMA PET/CT finding. Patterns of failure were defined as local-only (intraprostatic or seminal vesicle), nodal (regional lymph node with or without local failure), and distant (with or without local or nodal failures). Univariable multinomial logistic regression (UVA) was performed to evaluate predictors of nodal or distant recurrence vs. local only, and subsequent multivariable analyses (MVAs) were conducted including only variables with <i>P</i> < 0.1 on UVA. Variables evaluated included years since radiation, post-radiation nadir PSA, PSA at time of PSMA, initial disease features (cT stage, iPSA, Gleason grade group), and treatment variables (type of radiation, use of ADT, use of whole pelvis radiotherapy). <h3>Results</h3> There were 118 patients included in this study. Of these 118 patients, 17 (14%) were initially diagnosed with low-risk, 61 (52%) with intermediate-risk, and 40 (34%) with high-risk PCa. Median time since RT was 4.4 years (interquartile range [IQR], 2.5-7.4 years), and median PSA at time of PSMA was 4.9 ng/mL (IQR, 2.7-9.6). Local only failures were seen in 47 patients (40%), regional failures (without distant failures) in 23 patients (19%), and distant failures in 48 patients (41%). On UVA, higher iPSA and higher PSA at time of PSMA were associated with regional recurrence, while shorter interval from RT, higher Gleason grade, higher initial PSA, and higher PSA at time of PSMA were associated with distant disease. On MVA, only PSA at time of PSMA remained significant for distant recurrence (<i>P</i> = 0.003) and trended toward significance for regional recurrence (<i>P</i> = 0.07). <h3>Conclusion</h3> Nearly 40% of patients with radiorecurrent prostate cancer have local-only recurrences on PSMA imaging, while another 40% have distant disease. PSA at the time of PSMA imaging is a significant predictor of distant recurrence. Prospective studies evaluating salvage treatment approaches that integrate PSMA imaging data are warranted, and imaging at a lower PSA threshold should be considered.

PD19-10 PATIENT AND DISEASE SPECIFIC RISK FACTORS AND NERVE SPARING HAVE A SIGNIFICANT IMPACT ON LONG TERM SEXUAL FUNCTIONAL FOLLOWING MINIMALLY INVASIVE RADICAL PROSTATECTOMY

You have accessJournal of UrologyProstate Cancer: Localized: Surgical Therapy II (PD19)1 Sep 2021PD19-10 PATIENT AND DISEASE SPECIFIC RISK FACTORS AND NERVE SPARING HAVE A SIGNIFICANT IMPACT ON LONG TERM SEXUAL FUNCTIONAL FOLLOWING MINIMALLY INVASIVE RADICAL PROSTATECTOMY Nicholas Raison, Gledisa Musollari, Kathy Man, Natasha Bhate, Joanne Sethi, Alexandra Forde, Hashim Ahmed, Suks Minhas, and Mathias Winkler Nicholas RaisonNicholas Raison More articles by this author , Gledisa MusollariGledisa Musollari More articles by this author , Kathy ManKathy Man More articles by this author , Natasha BhateNatasha Bhate More articles by this author , Joanne SethiJoanne Sethi More articles by this author , Alexandra FordeAlexandra Forde More articles by this author , Hashim AhmedHashim Ahmed More articles by this author , Suks MinhasSuks Minhas More articles by this author , and Mathias WinklerMathias Winkler More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002008.10AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Erectile dysfunction remains a major source of morbidity for patients following radical prostatectomy (RP). This study aims to identify patient related as well as peri- and post-operative factors that may affect long-term sexual function following RP. METHODS: A prospectively maintained database of patients who had undergone minimally invasive RP was analysed. Patient reported outcomes measures were assessed in all patients using the validated RAND 36-Item Survey and UCLA prostate cancer index questionnaires completed at regular intervals PROMS evaluated functional (urinary, bowel and sexual scored out of 100) and general health outcomes following RP. Further data including clinical and pathological details for all patients was collected. Univariable logistic regression analysis was used to identify potential factors. Analysed factors were age, comorbidities, BMI, previous LUTS surgery, neoadjuvant or adjuvant radiotherapy or ADT, nerve sparing (NS), prostate size and complications. Potential factors were analysed graphically. Patients with pre (n=6) and post (n=163) RP radiotherapy were included. RESULTS: 494 of 700 patients had PROMS and were analysed with a mean follow up of 31 months (range 1-150 months). Mean preoperative sexual function score 54 (range 0-100) with sexual function score continuing to improve until 24 months. There was no long-term deterioration in either overall mental or physical health. NS had a significant effect on long term sexual function (p < 0.001) with progressive benefits following bilateral intrafascial and unilateral intrafascial/ extrafascial NS compared to no NS (Figure 1). Age and prostate size were the only patient related factors to impact post-operative sexual function (p=0.003 and p=0.03 respectively). Sexual function was also affected with the D’Amico risk group (p=0.001) and use of postoperative ADT (p=0.02). Adjuvant or neoadjuvant radiotherapy had no effect. CONCLUSIONS: Patient and disease specific factors and nerve sparing can have a significant effects on post operative sexual function. Discussion with the patient on individual risks should undertaken when making treatment decisions. Source of Funding: No funding © 2021 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 206Issue Supplement 3September 2021Page: e365-e366 Advertisement Copyright & Permissions© 2021 by American Urological Association Education and Research, Inc.MetricsAuthor Information Nicholas Raison More articles by this author Gledisa Musollari More articles by this author Kathy Man More articles by this author Natasha Bhate More articles by this author Joanne Sethi More articles by this author Alexandra Forde More articles by this author Hashim Ahmed More articles by this author Suks Minhas More articles by this author Mathias Winkler More articles by this author Expand All Advertisement Loading ...

Non-interventional study of treatment approaches in patients with locally advanced prostate cancer who have undergone prostatectomy or radiation therapy (PREVENT)

Background. Prostate cancer (PCa) is the second most common cancer in men. Currently there is no clear understanding of preferences among oncologists in Russia in decision-making process regarding adjuvant ADT in patients with locally advanced PCa with high and very high risk of recurrence after prostatectomy or radiotherapy.Objective: to provide accurate and reliable information regarding the adjuvant endocrine treatment in patients with locally advanced PCa in the Russian routine clinical practice.Materials and methods. This multicentre, non-interventional, prospective observational cohort study included 204 males (mean age 64.9 ± 6.2 years) with locally advanced PCa. The patients were enrolled at 18 sites in Russian Federation. Information on the routine diagnosis-specific examinations, including PSA measurements before, after and during one year after prostatectomy / radiotherapy was collected. Information regarding patient demographics, disease characteristics, management approaches, diagnostic tests and medications received by patients was taken from the medical records.Results. Among patients participated in the study, 64.4 % were treated surgically, and 38.6 % underwent radiotherapy; only 6 patients (4.6 %) underwent radical prostatectomy followed by radiotherapy. Median duration from diagnosis of PCa at the time of enrolment was less than 2.7 months, for 75 % of patients the disease duration did not exceed 7 months. ADT was used in 132 patients. ADT was received by 95.8 % of males treated with radiotherapy without radical prostatectomy and by 46.8 % of those who underwent radical prostatectomy without radiotherapy. Medical or surgical castration was used in 56.4 % of cases, antiandrogens without castration were used by less than 10 % of patients, while 28.2 % of patients received treatment with both castration and antiandrogens and the same number of males underwent only castration. Percentage of patients with PCa progression was 9.3 % for males after radical prostatectomy without radiotherapy and 7.4 % for those who underwent radiotherapy without radical prostatectomy. There were no cases of death due to PCa progression.Conclusion. The results are in alignment with international guidelines and standards. Received data can help to improve management approaches for treatment of Russian patients with high risk locally advanced PCa, particularly giving a basis for a decision on use of ADT.

A Novel Prostate SBRT vs HDR Comparison: A Disease Perspective

To compare current SBRT and HDR prostate treatment regimens from a disease perspective using the latest published dose-response functions We developed and validated a comprehensive software platform enabling in-silico growth of realistic prostate tumor-like volumes of random shape and morphology within prostate. Published probabilities of disease occurrence in various prostate zonal anatomies, for various disease stages were taken into account when tumorlets were generated. The model used the patient-specific segmented anatomy and dose distributions delivered for 10 patients. 4500 tumorlets, ranging from 0.1 to 10 cm3 were generated. Each tumorlet was overlapped with the dose distribution and the corresponding radiobiological integral parameters (EUBED, gBEUD) were computed. Data from 25 international radiotherapy outcome datasets, stratified by risk and use of ADT, were used to generate dose-response curves, fractionation sensitivity and repopulation. These values then enabled our model to convert integral metrics parameters into a probability of cure (PoC). A large range of radiobiological parameters, α/b = [1.5, 7.7] Gy and α = [0.04, 0.3] Gy-1 were explored in comparing currently accepted regimens (e.g. 7.25Gy x 5 and 13.5Gy x 2). SBRT plans were created using both RTOG 0938 and NRG GU005 criteria. A version of the plan was escalated from 36.25 to 40Gy. The two methods of integrating radio-biological dose effect (EUBED and gBEUD) handle dose inhomogeneity differently. SBRT plans display less dose inhomogeneity and consequently both formalisms produce very similar results. For HDR plans, which have more dose heterogeneity, the two formalisms produce slightly different results but for both, the PoC tends to decrease with the increased disease volume. Similar SBRT and HDR outcomes were observed for a very low α/b (1.5) and only low and intermediate risk disease. For higher α/b values, for all the dose-response curves examined, predictions showed that HDR provided a 5-30% increase in PoC, increasing with increased α/b and risk strata. The NRG plans, requiring higher dose coverage (98% vs 95%), produce, for the same prescription dose, a 1-5% PoC increase. The NRG 40Gy plans restore some of the PoC, when compared to HDR, particularly at large tumor volumes. We are presenting a novel perspective in comparing two treatment modalities or regimens. Our results show that using prescription dose alone in a BED-style equivalence, particularly when accounting for large degrees of variability in planning styles and delivery, has a limited value. The method we are proposing, looking at probabilities of cure at disease level –tumorlets- rather than physical peripheral prescription dose at gland level, has the potential to create a true equivalence between established and time-tested treatments (HDR) and newer modalities (SBRT), while accounting for all existent planning style variability.

Higher SBRT Dose Levels for Localized Prostate Cancer Are Associated with Improved Post-treatment Biopsy Outcomes

To investigate predictors associated with post-treatment biopsy outcomes after stereotactic body radiotherapy (SBRT) for localized prostate cancer. 231 patients treated with prostate SBRT to dose levels of 32.5 Gy to 42 Gy in five fractions (median dose 40Gy) underwent a post-treatment biopsy performed approximately two years after therapy to evaluate local control status. The majority of the patients had intermediate risk disease, 38.5% unfavorable, (n = 89) and 33.3% favorable (n = 77) and the remaining 18.6% (n = 43) and 9.5% (n = 22) had low and high-risk disease. 22.9% (n = 53) were treated with neoadjuvant and concurrent androgen deprivation therapy on conjunction with SBRT for a median duration of 4.6 months. Logistic regression analyses assessed relationships between factors and post-treatment biopsy outcomes (positive vs. negative/treatment effect). The median follow-up time was 46 months (range: 19-116 months). The incidence of positive, negative, and treatment-effect and biopsies were 16.0%, 56.3%, and 27.7%, respectively. The incidence of a positive biopsy according to dose was 33.3% (n = 8/24), 21.4% (n = 6/28), 19.4% (n = 6/31), 11.5% (n = 17/148) for 32.5 Gy, 35 Gy, 37.5 Gy and > = 40 Gy, respectively. The incidence of a positive biopsy was 7% (n = 3/43), 16.9% (n = 13/77), 21.3% (n = 19/89), and 9.1% (n = 2/22) for low, favorable intermediate, unfavorable intermediate and high risk respectively. Patients treated with SBRT doses of <40 Gy (OR: 2.59, 95%CI: 1.19-5.64, p = 0.016) and those with an unfavorable intermediate/high risk (OR: 2.31, 95%CI: 1.07-5.00, p = 0.034) had higher odds of a positive biopsy outcome. The use of neoadjuvant and concurrent ADT did not impact on post-treatment biopsy outcomes. In this cohort representing the largest number of post-treatment biopsies performed on patients treated with prostate SBRT, higher dose levels were associated with improved post-treatment biopsy outcomes independent of prognostic risk group.

Efficacy and Toxicity of Stereotactic Body Radiation Therapy for Localized Prostate Cancer: A Twelve-Year Study

This is the first study using Stereotactic Body Radiotherapy (SBRT) for organ confined prostate cancer to have patients with twelve-year follow-up. In this study, we report outcomes for prostate robotic SBRT in 560 patients, with NCCN low-, intermediate- and high- risk disease. We report on biochemical disease-free survival (bDFS), toxicity and Quality of Life (QOL). We studied 560 patients with organ-confined prostate cancer, treated with SBRT to a dose covering the PTV (prostate +3-5 mm) of 35-36.25 Gy. The prostate was covered by a dose of 38.4-40 Gy. Treatment was delivered in 5 daily fractions between 2006-2009. We included 45 high risk patients who received a 18-21 Gy SBRT boost after 45 Gy to the pelvis with EBRT. Median follow up is 132 months. The median age was 69 years, and median PSA was 6.58. 324 patients were low-risk, 153 were intermediate-risk and 83 were high-risk. ADT up to 9 months was administered to 102 patients. Patients were further stratified into low-intermediate risk versus high-intermediate risk, with high-intermediate risk criteria of Gleason 4+3 = 7 or >1 intermediate risk factors (cT2b-c, PSA 10-20, Gleason 7). Biochemical failure was assessed using the Phoenix criterion. Cox regression analysis was used to determine which risk factors were significantly associated with increased risk of biochemical failure. Twelve-year bDFS was 92.0, 79.1 and 64.0% for low, intermediate and high-risk group patients, respectively. Local control was 97.0, 91.7 and 88.0% respectively. Favorable intermediate-risk patients had excellent outcomes, with no significant difference compared to low-risk patients with 12-year bDFS 89.8 vs 92.0%, respectively (p = 0.35). Unfavorable intermediate-risk patients had outcomes similar to high risk patients, with 12-year bDFS of 67.5 and 64.0% respectively (p = .24). Median PSA declined to 0.1. For low and intermediate risk patients, Gleason score was the only significant factor predicting for biochemical failure on multivariate analysis (p = 0.0003), with ADT, dose and PSA not significant. For high risk patients, PSA was the only significant predictor of bDFS (p = .01), with Gleason score, ADT or EBRT not significant. Toxicity was mild. 36.25 Gy was associated with more Grade 2-3 late urinary toxicity than 35 Gy. (13.8% vs 6%) p = .01 Patients receiving EBRT had a higher rate of late Grade 2 late rectal toxicity. Mean EPIC QOL urinary and bowel domains for all patients declined during the first 3 months and then returned to baseline, where they remain. Mean sexual QOL scores have slowly declined by 47% This study suggests that early excellent control rates for SBRT for prostate cancer remain durable over 12 years. Similarly, toxicity rates remain low and QOL scores remain high over that period. For patients receiving SBRT alone, 35 Gy is as effective as 36.25 Gy with less urinary toxicity, suggesting 35 Gy may be the optimal dose. For high risk patients, use of EBRT and ADT do not appear to increase long term control rates.

Estimating acute urinary retention risk post prostate high dose-rate (HDR) brachytherapy: A clinical-based recursive partitioning analysis

PurposeTo determine factors associated with need for post-procedural catheterization in prostate cancer patients treated with 15 Gy high dose-rate brachytherapy boost (HDR-BT). Material and methodsPatients treated with 15 Gy HDR-BT followed by EBRT were retrospectively evaluated for development of urinary retention and hematuria requiring catheterization in the first 30 days post procedure. Clinical characteristics and treatment details were obtained and used as independent variables under study. Univariable and multivariable logistic regression analysis were used to determine predictors of post brachytherapy complications and a classification tree for risk of urinary retention was created using recursive partitioning analysis (RPA). ResultsA total of 425 patients treated with 15 Gy HDR-BT were included in this analysis. 27 patients (6.3%) required catheter placement due to acute urinary retention and thirteen other patients (3%) developed hematuria requiring urinary catheter insertion ± continuous bladder irrigation. Number of needles, prostate volume and prior use of ADT, alpha-blockers or 5α-reductase inhibitors were statistically associated with urinary retention in the univariable logistic regression analysis. In multivariable analysis, prostate volume, previous use of alpha-blocker, and use of ADT remained significant. In the RPA, populations were identified in which the rate of urinary retention ranged from 2% to 50% depending on presence of one or more of these risk factors. ConclusionThe overall rate of acute urinary complications post HDR brachytherapy is low, but the individual risk of urinary retention can increase depending on the number of risk factors present. A more patient-directed retention risk estimation can be performed by using the classification risk tree presented here.

Comparative efficacy of local versus systemic salvage therapies for recurrent prostate cancer after primary radiotherapy.

221 Background: We sought to compare two common salvage strategies for radio-recurrent prostate cancer: androgen deprivation therapy (ADT: PR7 RCT NCT00003653) or local salvage ablation using cryotherapy (CRYO: single institution study Williams, Eur Urol. 2011;60(3):405). Methods: Pre-salvage therapy prognostic variables common to the two datasets (Gleason score at initial treatment, time from original RT, use of ADT at time of original RT, PSA at time of salvage, patient age) were used for propensity matching between patients from previously published ADT (1) and CRYO (2) datasets. Progression free survival (PFS, defined as time from initial treatment to development of castrate resistance or death); Disease Specific Survival (DSS, defined as time from salvage to prostate cancer related death) and Overall Survival (OS, defined as time from salvage to death from any cause) were compared between the propensity matched cohorts using Log-Rank and Cox PH regression statistics. Raw linear propensity scores included in the PH model to account for residual variability. A planned subset analysis examined the effect of neoadjuvant ADT among the CRYO cohort (no CRYO patients had adjuvant ADT). Results: Overall, 1119/1386 (ADT) and 172/187 (CRYO) patients were included in the propensity matched analysis. Median follow up was 6.7 yrs (ADT) and 18.7 yrs (CRYO). Median PFS (95% CI) was 10.7 yrs (9.5, 12.3) for CRYO vs. 7.0 yrs (6.1, 10.0) for ADT (HR 0.63 (0.44, 0.89), p = 0.009). Median OS was also longer for CRYO vs. ADT: 12.3 (11.0, 13.8) vs. 10.2 (9.4, not reached) yrs (HR 0.69; p = 0.02). 10 year DSS event rate was 16.5% CRYO vs. 18.5% ADT but was not statistically different. Neoadjuvant ADT did not affect outcomes in CRYO. Conclusions: A 3-year PFS and 2-year OS benefit was noted for the CRYO vs. ADT cohorts while no difference was noted in DSS. Potential explanations include residual bias not corrected for in the propensity scoring, variable follow-up duration, adverse effects from differing cumulative exposure to ADT or a combination of these factors. Prospective comparisons are required to control for these potential biases and compare other important outcomes such as side effects and quality of life.

Positron emission tomography with 18F-fluciclovine to predict recurrence in post-treatment recurrent prostate cancer and its role in altering treatment plans.

214 Background: 18F-fluciclovine PET/CT can improve the detection of post-treatment recurrent prostate cancer (PCa). We quantified factors which increase the likelihood of a positive scan, assessed the ability of 18F-fluciclovine to alter treatment plans and identified an optimal PSA cut-off to identify radiographic recurrence. Methods: Patients who received 18F-fluciclovine PET/CT for recurrent PCa (n=78) were analyzed. Treatment changes based on positive scans were tracked. A receiver-operator characteristic (ROC) curve was used to estimate the optimal PSA cut-off for a positive scan. Results: 18F-fluciclovine predicted radiographic recurrence in 67.9% of patients. PSA at scan (p = 0.010), salvage therapy (p = 0.03), any use of ADT (p = 0.016) and number of studies (p = 0.042) were all associated with a positive scan. Alteration of treatment plans occurred in 34/58 (58.6%) patients. Recurrence sites are: 79/120 (65.8%) lymph nodes, 27/120 (22.5%) bone, 11/120 (9.2%) prostatic bed, and 3/120 (2.5%) elsewhere. The most common treatment alteration was directed stereotactic body radiation therapy (SBRT) (16/34, 47%), followed by salvage surgical therapy (4/34, 11.7%) and ADT (3/34, 8.7%).The optimal PSA cut-off was 0.5 with sensitivity of 81.13% and specificity of 78.38% (ROC=0.7880). Conclusions: 18F-fluciclovine PET/CT detected radiographic disease in 67.9% of patients, resulting in alterations in treatment plans in 58.6% of cases. SBRT was the most common alteration in treatment plan. Previous use of salvage therapy or ADT are risk factors and when combined with a PSA &gt;0.5, may be associated with radiographic recurrence. [Table: see text]