Low PSA Values Research Articles

FDG PET/CT Scan Still Can Help in Evaluation of Prostate Cancer.

Although 18F-FDG PET/CT scan is not the preferred modality to evaluate prostate cancer patients due to generally low uptake of FDG in prostate cancer cells, it can still be helpful in some selected cases with diagnostic dilemma. Here we are presenting an unusual prostate cancer case, status post radical prostatectomy, with heterogenous uptake in osseous lesions on 68Ga-PSMA PET/CT scan and low PSA values. He was referred for further evaluation with 18F-FDG PET/CT scan, revealing widely metastatic lesions in bone and liver, in addition to mildly avid recurrence in prostatectomy surgical bed and also metastasis in the spleen.

Clinical Factors Associated With Suspicious 18F-DCFPyL PSMA PET Activity in Patients Initially Managed With Radical Prostatectomy Including Prostate-Specific Antigen < 0.5 ng/mL.

There are limited data on PSMA PET/CT for workup of recurrence after radical prostatectomy (RP) at low PSA values. We evaluated a PSMA PET/CT cohort of patients with post-RP, focusing on patients with PSA < 0.5 ng/mL. We identified a retrospective cohort who underwent piflufolastat F-18 PSMA PET/CT across an 11 hospital system from July 2021 to February 2023. Prostate-specific membrane antigen (PSMA) positivity was determined by radiology reports. Univariable and multivariable logistic regression identified factors associated with suspicious PSMA activity. Median PSA was 0.37 ng/mL (IQR, 0.15-1.29 ng/mL), with 49% of patients overall having at least 1 suspicious PSMA-avid lesion. Rates of scan positivity among patients with PSA < 0.2 and 0.2 to 0.5 ng/mL were 34% and 38%, respectively. Among all patients, 25% (104/415) had pelvic disease (prostate bed or N1) and 24% (100/415) had M1 disease. Among patients with PSA < 0.5 ng/mL, prior postoperative radiation was associated with suspicious PSMA activity. In the overall cohort, age, PSA at PSMA PET/CT, and RP Gleason grade were associated with PSMA positivity. PSADT, EAU risk, and CAPRA-S were all associated with suspicious PSMA activity. Over one-third of patients with PSAs < 0.2 ng/mL had imaging findings concerning for recurrence. Prior postoperative radiation was associated with higher rates of PSMA positivity among patients with PSA < 0.5 ng/mL, and half of patients with evidence of PSMA avid distant metastatic disease underwent metastasis-directed therapy. PET-PSMA imaging at low PSAs can be considered to inform salvage therapies.

Salvage Radiotherapy PSMA PET/CT-guided in Men With PSA Recurrence.

To evaluate the clinical outcome in men with recurrent prostate cancer (PCa) treated by salvage radiotherapy (sRT) prostate-specific membrane antigen positron emission tomography/computed tomography (PSMA PET/CT)-guided. From January 2021 to January 2023, 33 patients who previously underwent definitive/systemic therapy were submitted to sRT PSMA PET/CT-guided for PCa recurrence: 16 (48.5%) on the prostate bed (PB), 12 (36.4%) on the lymph node (LN) and five (15.1%) on the bone. The median PSA value was 3.3 ng/ml (range=0.3-15.5 ng/ml): 0.2-0.5 ng/ml (18.2% cases), 0.51-1 ng/ml (39.4% cases) and >1 ng/ml (42.4% cases). Median 18F PSMA PET/CT standardized uptake value (SUVmax) was evaluated on PB, vs. LN vs. bones PCa recurrences and was equal to 12.5 vs. 19.0 vs. 30.1, respectively. Overall, at a median follow up of 12 months, 23/33 patients (69.7%) had local control without distant progression (PSA and SUVmax evaluation): 14/16 (87.5%) vs. 7/12 (58.3%) vs. 2/5 (40%) underwent sRT on the PB vs. LN vs. bone metastases, respectively. PSMA PET/CT allows to perform sRT early in men with PCa recurrence and low PSA values obtaining a complete clinical response in approximately 70% of the cases one year from treatment.

EAU Biochemical Recurrence Risk Classification and PSA Kinetics Have No Value for Patient Selection in PSMA-Radioguided Surgery (PSMA-RGS) for Oligorecurrent Prostate Cancer.

To assess the influence of biochemical recurrence (BCR) risk groups and PSA kinetics on the outcomes of radioguided surgery against prostate-specific membrane antigen (PSMA-RGS). Currently, neither BCR risk group nor PSA doubling time (PSA-DT), or PSA velocity (PSA-V) are actively assigned or relevant for counseling prior to PSMA-RGS. We retrospectively analyzed PSMA-RGS cases for oligorecurrent prostate cancer between 2014 and 2023. BCR risk groups, PSA-DT, and PSA-V were analyzed as predictors for complete biochemical response (cBR, PSA < 0.2 ng/mL), BCR-free, and therapy-free survival (BCRFS, TFS). Of 374 included patients, only 21/374 (6%) and 201/374 (54%) were classified as low- and high-risk BCR (no group assignment possible in 152/374, 41%). A total of 13/21 (62%) patients with low- and 120/201 (60%) with high-risk BCR achieved cBR (p = 1.0). BCR classification was no predictor for BCRFS (HR:1.61, CI: 0.70-3.71, p = 0.3) or subsequent TFS (HR:1.07, CI: 0.46-2.47, p = 0.9). A total of 47/76 (62%) patients with PSA-DT ≤ 6 mo and 50/84 (60%) with PSA-DT > 6 mo achieved cBR (p = 0.4). PSA-DT was not associated with cBR (OR: 0.99, CI: 0.95-1.03, p = 0.5), BCRFS (HR: 1.00, CI: 0.97-1.03, p = 0.9), or TFS (HR: 1.02, CI: 0.99-1.04, p = 0.2). Consistent negative findings were recorded for PSA-V. The BCR risk groups and PSA kinetics do not predict the oncological success of PSMA-RGS performed at low absolute PSA values. Indolent low-risk BCR is rarely treated by PSMA-RGS.

Change in Therapeutic Approach after PET/TC PSMA-18F DCFPyL in Occult Biochemical Recurrence of Prostate Carcinoma with Low PSA Values

To analyze changes in therapeutic attitude after PET-PSMA. in patients with occult biochemical recurrence after primary treatment with low PSA values. Retrospective study of patients diagnosed with prostate carcinoma who after primary treatment with curative intent present biochemical recurrence with low PSA values (<2ng/ml) and negative imaging tests (ultrasound, CT-Scan, MRI, GGO and/or PET-Choline). The assessment was performed by two expert nuclear physicians. All patients underwent a study with 300-350MBq PSMA-18F DCFPyL PET/TC, and after a follow-up of no less than six months we assessed whether there were changes in therapeutic attitude directly related to the results of the test. The clinical/therapeutic evaluation was performed by expert radiation oncologists. Descriptive statistical analysis was performed. RoC curves (sensitivity vs. 1-specificity) and the corresponding areas under the curve were calculated to assess the predictive power of the study. PET-PSMA with complete follow-up was performed on 85 patients aged 48-78 years (mean age 69 years) with occult biochemical recurrence. Most patients were staged T2 (50.58%) - T3 (48.23%), cases N1 (10.58%), Gleason score ≥ 7 (96%) with mean PSA level 11.24 ng/ml at diagnosis. The mean nadir PSA values of 0.13 mg/dl following primary treatment with radical intent. In 48.2% of patients (41/85) had a positive PET-PSMA during follow-up, pre-study the median PSA levels were 0,62 ng/dl. There is a correlation between the PSA value and the ability to detect disease in the PET-PSMA study (AUC: 0,74). In 75% of patients with positive PET-PSMA (31/41) there were changes in the therapeutic approach. This proportion was significantly lower (25%) in those without pathological PET findings (11/44). In PET-PSMA-positive patients the therapeutic changes found were classified as indicating or changing the planning of salvage radiotherapy treatment and/or initiating systemic treatment with hormone therapy (median PSA levels after treatment changes were 0.08 ng/dl). In cases with negative PET-PSMA a watchful waiting attitude was adopted. PET-PSMA is a powerful diagnostic tool that conditions significant changes in the therapeutic approach in those patients with occult biochemical recurrence with low PSA, changing the treatment in 75% of the cases when the study is positive.

Diagnostic Utility of PSMA 18F-DCFPyL PET/TC in Occult Biochemical Recurrence of Prostate Carcinoma with PSA Values

To analyze the diagnostic capability of PET-PSMA in clinical practice in patients with occult biochemical recurrence of prostate carcinoma with PSA values less than 2ng/ml. The first 116 patients who underwent PSMA 18F-DCFPyL PET/TC at the centers participating in the study for occult biochemical recurrence of prostatic neoplasia were selected. All patients had low PSA values (<2ng/ml). The studies were visually assessed by two experts in Nuclear Medicine, and classified dichotomously as positive or negative/inconclusive. The diagnostic capacity of the test was determined according to the PSA values, as well as the densities by groups. Descriptive statistical analysis was performed. The AUC was evaluated, determining the optimal cut-off point and its precision parameters. The retrospective analysis showed that 66/116 patients (56.9%) were positive, with statistically significant differences in the medians of the positive group (AUC 0.77) and 50/116 (43.1%) patients were negative (AUC 0.42). The study of densities by group showed a marked clustering of the negative/ inconclusive studies in PSA values less than 0.5 ng/ml. Correlation was observed between the PSA values and the detection capability of the test (AUC: 0,74). The optimal cut-off point calculated was 0,55 which showed a sensitivity of 0,75 and specificity of 0,68. PET-PSMA shows excellent diagnostic capability even in strictly selected patients with PSA values < 2ng/ml. Its indication with values < 0.5ng/mL should be assessed according to individual risk. In 56.9% of the patients in the study the positive result could influence changes in therapeutic strategy.

Personalized [177Lu]Lutetium-PSMA Therapy for Patients with Pre-Treated Castration-Resistant Prostate Cancer: A Single Institution Experience from a Comprehensive Cancer Centre.

Castration resistant prostate cancer (CRPC) is characterized by an aggressive biological behavior with a relatively short survival time, especially in progressive tumors pretreated with new hormonal agents and taxane chemotherapy. [177Lu]-Lutetium-PSMA (Lu-PSMA) treatment has proven efficacy in these patients. However, around 30% of the CRPC patients do not benefit from Lu-PSMA treatment, and little is known about predictive factors for treatment success if Lu-PSMA is offered in an individualized approach based on clinical and laboratory features. In this monocentric retrospective study, 86 CRPC patients receiving Lu-PSMA treatment were evaluated. The focus of the study was to describe clinical factors at baseline and during early treatment that are related to overall survival (OS). In addition, PSMA PET/CT-, PSA-response, and safety and tolerability (CTCAE adverse event reporting) were assessed. Efficacy endpoints were calculated using stratified Kaplan-Meier methods and Cox regression models. Mean applied dose was 17.7 GBq (mean 5.3 ± 1.1 GBq per cycle) with an average of 3.6 (range 1-8) therapy cycles. Patients were followed up for a mean of 12.4 months (range 1-39). The median OS was 15 months (95% CI 12.8-17.2). The best overall response rate in patients assessed with PSMA PET/CT and PSA response was 27.9%, and 50.0% had at least stable disease. Nine patients had a ≥grade 3 adverse event with anemia being the most frequent adverse event. Positive predictors for prolonged OS from baseline parameters were pre-treatment hemoglobin level of ≥10 g/dL and a lower PSA values at treatment start, while the presence of visceral or liver metastases were not significantly associated with worse prognoses in this cohort. With careful patient selection, an individualized Lu-PSMA treatment approach is feasible and patients with dose-limiting factors or visceral metastases should be included in prospective trials.

68GaPSMA-11 PET/CT to monitor treatment response in patients with metastatic prostate cancer: The concordance between biochemical response and PSMA response.

49 Background: The aim of this study was to assess whether PSMA PET is associated with flares, with discordant results in regard to biochemical response, and with positivity rates at low PSA values while monitoring metastatic prostate cancer (mPCa) receiving systemic treatment. Methods: A total of 96 patients with PSMA PET-detected mPCa who underwent at least one follow-up scan after receiving systemic treatment were included in the study. PSA levels at baseline PSMA PET-CT (bPSMA) and follow-up PSMA PET scans (fPSMA) were recorded. Any significant PSMA uptake at prostate and/or metastatic lesions were considered PSMA positivity. PSMA response were decided according to PSMA PET Progression (PPP) criteria . Biochemical progression was defined as ≥25% increase in PSA (1 ng/dL was the minimal starting value). PSMA PET and PSA response were dichotomized into progressive disease (PD) vs non-PD. Discordant responses among different metastases and prostate were defined as the condition when some metastatic lesions (or prostate) are responding (CR or PR) to systemic treatment while others had progressed. Results: A total of 346 serial PSMA PET/CT (96 bPSMA and 249 fPSMA) scans were evaluated. The median time between consecutive PSMA PET scans was 6.3 months (IQR: 4.7 – 10.6) Overall PSMA PET positivity rate of fPSMA scans was 88.4% (220/249). PSMA positivity rates according PSA levels were summarized. PPP was detected in 93 cases (37.8%) and biochemical progression was observed in 73 cases (30.2%). PSA and PSMA responses were highly concordant (Cohen’s K=0.623, p&lt;0.001). PSA-PSMA discordant responses were detected in 39 scans (17%). The possible causes could be identified in 34 of 39 scans (87%) while no obvious reason for discordance could be shown in the remaining 5. Conclusions: PSMA PET/CT showed very high detection rates of malignant lesions even in very low PSA values when monitoring treatment response in patients receiving systemic treatment for mPCa. PSA and PSMA responses were highly concordant. In cases with discordance, the reason seems to be the discordant behaviour of intraprostatic and metastatic lesions and not necessarily PSMA flares. PSMA PET is a promising biomarker to assess treatment response in patients with mPCa. [Table: see text]

18F]fluciclovine vs. [18F]fluorocholine Positron Emission Tomography/Computed Tomography: A Head-to-Head Comparison for Early Detection of Biochemical Recurrence in Prostate Cancer Patients.

Nowadays, there is still no consensus on the most accurate PET radiopharmaceutical to early detect prostate cancer (PCa) relapse. A tailored radiotracer choice based on a specific patient's profile could ensure prompt disease detection and an improvement in patients management. We aimed to compare the [18F]fluciclovine and [18F]fluorocholine PET/CT detection rate (DR) in PCa patients restaged for early biochemical recurrence (BCR), according to clinical and biochemical features. A cohort of 138 PCa patients with early BCR (mean age: 71 y, range: 50-87 y) were homogeneously randomized 1:1 to a [18F]fluciclovine or a [18F]fluorocholine PET/CT group. The respective PET/CT DR, according to per-patient and per-region analysis, and the impact of the biochemical, clinical, and histological parameters, were compared. The PSA cut-off values predictive of a positive scan were also calculated. Overall, the [18F]fluciclovine PET/CT DR was 64%, significantly higher than the [18F]fluorocholine PET/CT DR of 35% (p = 0.001). Similarly, in the per-region analysis, the [18F]fluciclovine PET/CT DR was 51% in the prostate region, significantly higher compared to 15% of [18F]fluorocholine (p < 0.0001). Furthermore, a statistically significant higher DR in per-patient and per-region (prostate/prostate bed) analysis was observed in the [18F]fluciclovine group for 0.5-1 ng/mL (p = 0.018, p = 0.049) and >1 ng/mL (p = 0.040, p < 0.0001) PSA values. A PSA of 0.45 ng/mL for [18F]fluciclovine and of 0.94 ng/mL for [18F]fluorocholine was identified as the optimal cut-off value in predicting a positive PET/CT scan. Our results demonstrated a better [18F]fluciclovine PET/CT DR compared to [18F]fluorocholine for restaging PCa patients in early BCR, particularly in the detection of locoregional recurrence. The significantly higher [18F]fluciclovine DR for low PSA values (PSA < 1 ng/mL) supports its use in this setting of patients.

Correlation Between Long-Term Acetylsalicylic Acid Use and Prostate Cancer Screening with PSA. Should We Reduce the PSA Cut-off for Patients in Chronic Therapy? A Multicenter Study.

PurposeTo evaluate the prostate cancer (PCa) detection rate in men with chronic use of Aspirin and to compare it with the detection rate of non-users.Patients and MethodsProspectively maintained database regarding patients undergoing prostate biopsy over the last 10 years in five institutions. Patients were divided into two groups according to their exposure to Aspirin. We relied on multivariable linear and logistic regression models to test whether Aspirin administration was associated with lower PSA values at prostate biopsy, higher PCa diagnosis, and higher Gleason Grade Grouping (GGG) at biopsy.ResultsWere identified 1059 patients, of whom 803 (76%) did not take Aspirin vs 256 (24%) were taking it. In multivariable log-linear regression analysis, Aspirin administration was associated with lower PSA levels (OR 0.83, 95% CI 0.71–0.97, p = 0.01), after controlling for age, prostate volume, smoking history, associated inflammation at prostate biopsy, presence of PCa at biopsy, and GGG. In multivariable logistic regression analysis, Aspirin administration was not found to be a predictor of PCa at prostate biopsy (OR 1.40, 95% CI 0.82–2.40, p = 0.21) after controlling for age, PSA, smoking history, prostate volume, findings at digital rectal examination and the number of biopsy cores. In patients with PCa at prostate biopsy (n = 516), Aspirin administration was found to predict higher GGG (OR 2.24, 95% CI 1.01–4.87, p = 0.04).ConclusionAspirin administration was found to be a predictor of more aggressive GGG. These findings suggest that a lower PSA threshold should be considered in patients taking Aspirin, as, despite low PSA levels, they might harbour aggressive PCa.

Cohort study of patients with oligorecurrent prostate cancer: Oncological outcomes of patients treated with salvage lymph node dissection via PSMA radioguided surgery.

5009 Background: Prostate-specific membrane antigen (PSMA) positron-emission tomography (PET) allows detection of small and/or atypically localized metastatic prostate cancer (PCa) lesions. In a subset of patients with recurrent oligometastatic PCa salvage surgery with PSMA-targeted radioguidance (PSMA-RGS) may be of value. We aimed to evaluate the oncological outcomes of salvage PSMA-RGS for oligo-recurrent PCa and determine predictive preoperative factors of improved outcomes. Methods: In this cohort study within two tertiary care centers, patients with biochemical recurrence (BCR) after radical prostatectomy (RP) and imaging with PSMA PET receiving salvage PSMA-RGS between 2014 and 2020 were analyzed. Kaplan-Meier and multivariable Cox regression models adjusted for various parameters were used to test for BCR-free survival (BFS) and therapy-free survival (TFS) differences. Postoperative complications were classified according to Clavien-Dindo. Results: Overall, 364 patients were assessed. At PSMA-RGS, median (IQR) age and preoperative PSA was 67 (61-71) years and 1.0 (0.5-1.9) ng/ml. Metastatic soft-tissue lesions from PCa metastases could be removed in 343 (94.2%) patients. Within three months from surgery, 24 (6.6%) patients suffered from Clavien-Dindo complications grade III-IV. During follow-up, 225 patients experienced BCR and 121 patients received further therapy. Median follow-up for patients who did not experience BCR and who did not receive further therapy was 10.8 months and 10.3 months, respectively. Median (IQR) BFS and TFS was 7.8 (5.4-10.5) and 35.5 months (25.9-45.9 months). At two years of follow-up, BFS rate was 31.9% and TFS rate was 58.0%. In multivariable analyses, higher preoperative PSA (HR: 1.1), higher number of PSMA-avid lesions on preoperative imaging (HR: 1.2) and multiple (pelvic plus retroperitoneal) localizations (HR: 1.9), as well as retroperitoneal localization (HR: 2.0) of lesions in PSMA PET imaging were independent predictors of BCR after PSMA-RGS. Limitations are the retrospective design and lack of a control group. Conclusions: As salvage surgery in oligo-recurrent PCa currently constitutes an experimental treatment approach careful patient selection is mandatory based on life expectancy, low PSA values and low number of PSMA PET avid lesions located in the pelvis. Further studies are needed to confirm our findings and define the oncological value of salvage surgical procedures in oligo-recurrent PCa.

MP33-18 ASSOCIATION OF PATIENT AND IMAGING-RELATED FACTORS WITH FALSE NEGATIVE FUSION BIOPSIES OF PI-RADS 4 AND 5 LESIONS ON MRI

You have accessJournal of UrologyCME1 May 2022MP33-18 ASSOCIATION OF PATIENT AND IMAGING-RELATED FACTORS WITH FALSE NEGATIVE FUSION BIOPSIES OF PI-RADS 4 AND 5 LESIONS ON MRI Miyad Movassaghi, Firas Ahmed, Hanisha Patel, Lyndon Luk, Elias Hyams, Sven Wenske, and Hiram Shaish Miyad MovassaghiMiyad Movassaghi More articles by this author , Firas AhmedFiras Ahmed More articles by this author , Hanisha PatelHanisha Patel More articles by this author , Lyndon LukLyndon Luk More articles by this author , Elias HyamsElias Hyams More articles by this author , Sven WenskeSven Wenske More articles by this author , and Hiram ShaishHiram Shaish More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002587.18AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: In patients who end up having a negative MRI/TRUS-fusion biopsy (TBx) with positive systematic biopsies in the sextant core corresponding with the targeted area or adjacent sextant cores notable for clinically significant prostate cancer (csPCa), identifying the source of error to rule out missed disease is critical. The goal of this study was to investigate whether specific imaging and patient-related factors, including discrepant US and MRI prostate segmentation volumes, are associated with a false negative (FN) TBx of PI-RADS 4/5 lesions. METHODS: This was a retrospective study of patients with PI-RADS 4 or 5 peripheral zone (PZ) lesions on MRIs performed between 11/2015-12/2020 and subsequent TBx. Biopsied lesions were separated into true positive (TP), false positive (FP) and false negative (FN) using a combination of systematic and fusion biopsy and grade group 2 or higher as the reference standard. FP cases were excluded. FN TBx was defined as negative targeted fusion cores with adjacent positive systematic cores. The impact of patient and imaging-specific factors on the probability of a FN fusion biopsy were tested using logistic regression. RESULTS: 530 consecutive patients with 685 PI-RADS 4 or 5 PZ lesions on MRI and subsequent TBx were retrospectively collected. 361 lesions in 304 patients (median age 69 years, IQR 63-75, median PSA 6.5 ng/ml, IQR 4.7-9.3), including 67 (19%) FN and 294 TP (81%) were included. There was a significant inverse association between lesion size and probability of FN biopsy (odds ratio (OR): 0.90, 95% CI: 0.85 - 0.95, p-value: <0.0001). Similarly, PSA level was inversely associated with a FN biopsy (OR: 0.86, 95%CI: 0.77 - 0.93, p-value: 0.0003). The probability of a FN TBx was not associated with use of an enema prep before MRI, size of prostate gland, discrepancy between US and MRI segmented prostate volume or the operator (p-value >0.05). CONCLUSIONS: Among men undergoing TBx, lower PSA values and smaller PI-RADS 4/5 lesions are associated with FN fusion biopsies. Discrepant US and MRI prostate segmentation volumes derived as part of fusion biopsy were not associated with a FN biopsy. Our data support a biopsy strategy for select men, especially those with smaller PI-RADS 4/5 lesions, that includes a concomitant SBx at the time of TBx. Source of Funding: None © 2022 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 207Issue Supplement 5May 2022Page: e576 Advertisement Copyright & Permissions© 2022 by American Urological Association Education and Research, Inc.MetricsAuthor Information Miyad Movassaghi More articles by this author Firas Ahmed More articles by this author Hanisha Patel More articles by this author Lyndon Luk More articles by this author Elias Hyams More articles by this author Sven Wenske More articles by this author Hiram Shaish More articles by this author Expand All Advertisement PDF DownloadLoading ...

PD41-02 DIAGNOSIS OF PROSTATE CANCER IN MEN TREATED WITH 5-ALPHA-REDUCATES INHIBITORS WITH MULTIPARAMETRIC MRI: RESULTS OF A MULTICENTER INTERNATIONAL COLLABORATION

PD41-02 DIAGNOSIS OF PROSTATE CANCER IN MEN TREATED WITH 5-ALPHA-REDUCATES INHIBITORS WITH MULTIPARAMETRIC MRI: RESULTS OF A MULTICENTER INTERNATIONAL COLLABORATION

Cohort study of oligorecurrent prostate cancer patients: Oncological outcomes of patients treated with salvage lymph node dissection via PSMA radioguided surgery.

106 Background: Prostate-specific membrane antigen (PSMA) positron-emission tomography (PET) allows detection of small and/or atypically localized metastatic prostate cancer (PCa) lesions. In a subset of patients with recurrent oligometastatic PCa salvage surgery with PSMA-targeted radioguidance (PSMA-RGS) may be of value. We aimed to evaluate the oncological outcomes of salvage PSMA-RGS for oligorecurrent PCa and determine predictive preoperative factors of improved outcomes. Methods: In this cohort study within two tertiary care centers, patients with biochemical recurrence (BCR) after radical prostatectomy (RP) and imaging with PSMA PET receiving salvage PSMA-RGS between 2014 and 2020 were analyzed. Kaplan-Meier and multivariable Cox regression models adjusted for various parameters were used to test for BCR-free survival (BFS) and therapy-free survival (TFS) differences. Postoperative complications were classified according to Clavien-Dindo. Results: Overall, 364 patients were assessed. At PSMA-RGS, median (IQR) age and preoperative PSA was 67 (61-71) years and 1.0 (0.5-1.9) ng/ml. Metastatic soft-tissue lesions were removed in 356 (94.4%) patients. Within three months from surgery, 25 (6.6%) patients suffered from Clavien-Dindo complications grade III-IV. During follow-up, 235 patients experienced BCR and 129 patients received further therapy. Median follow-up for patients who did not experience BCR and who did not receive further therapy was 11.1 months and 10.5 months, respectively. Median (IQR) BFS and TFS was 7.8 (5.4-10.9) and 34.9 (24.7-43.5) months. At two years of follow-up, BFS rate was 31.9% and TFS rate was 56.6%. In multivariable analyses, higher preoperative PSA (HR: 1.06), higher number of PSMA-avid lesions on preoperative imaging (HR: 1.2) and multiple (pelvic plus retroperitoneal) localizations (HR: 1.7), as well as retroperitoneal localization (HR: 2.0) of lesions in PSMA PET imaging were independent predictors of BCR after PSMA-RGS. Limitations are the retrospective design and lack of a control group. Conclusions: As salvage surgery in oligorecurrent PCa currently constitutes an experimental treatment approach careful patient selection is mandatory based on life expectancy, low PSA values and low number of PSMA PET avid lesions located in the pelvis. Further studies are needed to confirm our findings and define the oncological value of salvage surgical procedures in oligorecurrent PCa.

Aspartyl (Asparaginyl) β-hydroxylase (AABH) as a serum biomarker for prostate cancer, to identify prostate cancer, regardless of PSA level.

226 Background: Prostate Cancer (PC) is the most common form of cancer in men in the United States. In their lifetime, approximately 1 out of every 6 American men will develop PC. The chances of developing PC increase dramatically after age 50 with more than 72% of cases occurring in individuals over 65 years of age. Methods: We have investigated the use of aspartyl (asparaginyl) β-hydroxylase (AABH) as a cancer biomarker. We have developed a sandwich ELISA for its detection. Here this assay was utilized to screen sera from patients with prostate cancer and PSA values in various ranges. Results: AABH levels were assessed in sera from 263 individuals with PC and 73 men over 50 years of age not known to have cancer. The levels of AABH in the two groups were &gt; 3.00 ng/ml and &lt; 3.00 ng/ml, respectively. The overall sensitivity and specificity of the test were 97.5% and 96%. AABH and PSA levels were also compared. The AABH values and sensitivities in individuals with PC and PSA values in the ranges &lt; 2 ng/ml, 2-4 ng/ml and &gt; 4 ng/ml were &gt; 3.00 ng/ml, 99% (n = 115); &gt; 3.00 ng/ml, 98% (n = 64) and &gt; 3.00 ng/ml, 95% (n = 114). Conclusions: The present study of AABH indicates that cancer group can be clearly distinguished from normal healthy controls. Moreover, the study indicates that AABH might be used to identify disease in individuals with questionable PSA values. These results support to the establishment of routine screening of serum AABH as a means to detect those who need referral for prostate biopsy. The use of AABH testing may enhance current prostate cancer screening practices by both identifying individuals with low but suspicious PSA values who should be recommended for biopsy and reducing the number of false biopsies indicated by positive PSA tests. Serum AABH levels are significantly elevated in individuals with prostate cancer. Using a cutoff value of 3ng/ml, overall sensitivity of the assay for prostate cancer is 97%. The test has a specificity of 96% in healthy men over 50 years of age. AABH is elevated in prostate cancer tissue but NOT in normal prostate or in Benign Prostatic Hyperplasia (BPH). Serum AABH levels are NOT correlate with PSA levels.

Evaluation of hybrid PET/CT imaging with the 68Ga-labelled PSMA ligand in patients with prostate cancer and biochemical progression in the low-range values of PSA after radical prostatectomy

Introduction: Currently 68 Ga-PSMA PET/CT is making a significant shift in the diagnosis, staging and restaging of prostate cancer (PC) patients. Мany questions have been raised concerning the indications and the sensitivity of the method. Most of them are related to the PSA values in biochemical progression, specifically in the low PSA values of up to 2.00 ng/mL. Aim: The aim of this study was to analyze the influence of PSA values in biochemical progression on 68 Ga-PSMA PET/CT sensitivity, detection rate and the association with regional or metastatic lesions incidence in patients after radical prostatectomy (RP) with a focus on the impact of the lower ranges of the PSA values. Material and Methods: We performed a retrospective analysis in 144 consecutive patients with radical prostatectomy (RP) who underwent 68 Ga-PSMA PET/CT from July 2019 to February 2020. The patients were divided into six groups according to the PSA value: 1) ≤ 0.040 ng/mL; 2) 0.041–0.160 ng/mL; 3) 0.161–0.500 ng/mL; 4) 0.501–1.0 ng/mL; 5) 1.001–2.00 ng/mL; 6) &gt; 2.00 ng/mL. Results and Discussion: The mean age of the patients was 67.3 (7) years and the mean PSA level was 11.0 (52.28) ng/mL. A total of 62 patients (43.1%) showed at least one positive lesion. 68 Ga-PSMA PET/CT detection rate varied into the different groups between 12.0% and 94.0%. There was a significant relationship between the PSA level and the ability of 68 Ga-PSMA PET/CT to detect the lesions. Local recurrence was determined in patients with higher PSA values. Regional metastatic lymph nodes incidence in the 6 groups was between 17.0% and 50.0%. Bone metastases were most commonly diagnosed in patients with low PSA levels. Distant lymph nodes involvement in the studied groups ranged between 0.0% and 75.0%. Distant metastases were detected most commonly in patients with low levels of PSA. The PSA-based assessment of the overall sensitivity and specificity of 68 Ga-PSMA PET/CT was 58.0% and 87.0%, respectively. Sensitivity of 15.0% was found in the group with the lowest mean PSA levels. Conclusion: Tumor detection rate is positively associated with PSA levels. Biochemical progression after RP is more commonly related to distant metastases, specifically bone metastases in patients with lower levels of PSA.

Positivity Rate of [18F]Fluciclovine PET/CT in Patients with Suspected Prostate Cancer Recurrence at PSA Levels Below 1 ng/mL.

Early and precise localization of recurrent prostate cancer lesions after local therapy facilitates optimal disease management. Here, we present results from a single-center study to evaluate the utility of [18F]fluciclovine PET/CT to localize prostate cancer recurrence in patients with PSA <1 ng/mL. Data from men who underwent [18F]fluciclovine PET/CT (August 2016-March 2020) for suspected recurrent prostate cancer and who had a PSA value <1ng/mL were retrospectively reviewed. The number of positive scans (positivity rates, PR) was calculated for the whole body, prostate/bed, and extraprostatic regions (pelvic or extrapelvic lymph nodes, bones, and soft tissue). PR were stratified by pre-scan PSA. Data from 113 patients were included. In total, 98 (87%) were post-prostatectomy and 15 (13%) had received non-surgical primary therapy. Twenty patients (18%) were receiving ADT at the time of the scan, 91 (81%) were not, and ADT status was not known for 2 (1.8%) patients. The overall PR at PSA <1ng/mL was 59% (67/113). For the prostate/bed, it was 35% (40/113), and for extraprostatic locations, it was 37% (42/113). At PSA >0-<0.2, 0.2-<0.5, and 0.5-<1 ng/mL, the overall PR was 43% (10/23), 70% (35/50), and 55% (22/40), respectively. In the prostate/bed, these were 13% (3/23), 50% (25/50), and 30% (12/40), respectively, and in extraprostatic lesions were 30% (7/23), 44% (22/50), and 33% (13/40), respectively. Pelvic lymph nodes were the most common site for extraprostatic lesions (29/113, 26%). PR in extrapelvic lymph nodes, bone, and soft tissue were 8.0%, 12%, and 3.5%, respectively. Soft tissue lesions comprised lung nodules (n=3) and a perirectal mass implant (n=1). Despite low PSA values, more than half of patients had positive [18F]fluciclovine PET/CT findings. Patients with low PSA levels may demonstrate suspicious findings outside of the pelvis, including abdominal lymph nodes and metastatic disease to bones and lungs.

MP15-19 68Ga-PSMA PET/CT For RECURRENT PROSTATE CANCER AFTER RADICAL PROSTATECTOMY: WHAT IS NEXT?

You have accessJournal of UrologyProstate Cancer: Localized: Surgical Therapy I (MP15)1 Sep 2021MP15-19 68Ga-PSMA PET/CT For RECURRENT PROSTATE CANCER AFTER RADICAL PROSTATECTOMY: WHAT IS NEXT? Giorgio Gandaglia, Daniele Robesti, Nicola Fossati, Armando Stabile, Enrico Camisassa, Vito Cucchiara, Marco Moschini, Andrea Necchi, Giuseppe Rosiello, Riccardo Leni, Renzo Colombo, Pierre I. Karakiewicz, Francesco Montorsi, and Alberto Briganti Giorgio GandagliaGiorgio Gandaglia More articles by this author , Daniele RobestiDaniele Robesti More articles by this author , Nicola FossatiNicola Fossati More articles by this author , Armando StabileArmando Stabile More articles by this author , Enrico CamisassaEnrico Camisassa More articles by this author , Vito CucchiaraVito Cucchiara More articles by this author , Marco MoschiniMarco Moschini More articles by this author , Andrea NecchiAndrea Necchi More articles by this author , Giuseppe RosielloGiuseppe Rosiello More articles by this author , Riccardo LeniRiccardo Leni More articles by this author , Renzo ColomboRenzo Colombo More articles by this author , Pierre I. KarakiewiczPierre I. Karakiewicz More articles by this author , Francesco MontorsiFrancesco Montorsi More articles by this author , and Alberto BrigantiAlberto Briganti More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000001996.19AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: The use of 68Ga-PSMA PET/CT is recommended for prostate cancer (PCa) re-staging in patients with either PSA persistence or biochemical recurrence (BCR) after radical prostatectomy (RP). Although PSMA PET/CT is characterized by a high sensitivity even at low PSA values, its prognostic implications as well as the patterns of subsequent progression has been poorly addressed METHODS: We retrospectively identified 182 patients who were evaluated with 68Ga-PSMA PET/CT for BCR after RP between 2016 and 2020. Patients were stratified according to PSMA PET/CT into two groups: positive (n=116) vs. negative (n=66) scan. Pathological features and salvage treatments were compared. Kaplan-Meier analyses assessed the time the first PSMA PET/CT to disease progression. Cox regression analyses assessed the impact of a positive PSMA PET/CT on progression after adjusting for confounders. Per-lesion analysis using Pearson Chi-square assessed the impact of a positive PSMA PET/CT on the location of clinical recurrence after PSMA PET/CT RESULTS: Median PSA at PSMA PET/CT scan and time from surgery to BCR were 0.7 ng/ml and 49 months. At a median follow-up of 16 months after the first PSMA PET/CT, 46 patients experienced progression. Overall, 13 vs. 33 patients experienced progression in negative vs. positive groups. No differences were observed for pathologic stage, ISUP group grade, pN status and the rate of salvage RT and HT (all p≥0.07). The 3-year progression-free survival rates were 75 vs. 40% for negative vs. positive PSMA PET/CT scan at the time of BCR. At MVA, a positive PSMA PET/CT scan was associated with a 2-fold higher risk of progression compared to a negative PSMA PET/CT (p=0.01). Median time to secondary progression in PSMA negative and positive PET was 44 and 25 months (p=0.006). In men with negative PSMA (n=66) patterns of recurrence was not influenced by receipt of salvage RT (no SRT: 37% pelvic, 62% lung vs. SRT 30% pelvic, 70% lung). In men with positive PSMA PET/CT no differences in terms of site of recurrences were seen between those receiving metastasis directed therapy (MDT) vs androgen deprivation therapy (ADT: pelvic 28%, bone 35% visceral 35% vs MDT pelvic 50% bone 10% visceral 40%). CONCLUSIONS: A negative PSMA PET/CT scan is a protective factor for metastases during follow-up. Patents with negative PSMA did not show any bony progression during follow-up. The pattern of recurrence was not influenced by the use of any salvage treatment both in negative and positive PSMA PET patients. Salvage therapies might impact on disease progression but do not alter patterns of PCa dissemination Source of Funding: None © 2021 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 206Issue Supplement 3September 2021Page: e271-e271 Advertisement Copyright & Permissions© 2021 by American Urological Association Education and Research, Inc.MetricsAuthor Information Giorgio Gandaglia More articles by this author Daniele Robesti More articles by this author Nicola Fossati More articles by this author Armando Stabile More articles by this author Enrico Camisassa More articles by this author Vito Cucchiara More articles by this author Marco Moschini More articles by this author Andrea Necchi More articles by this author Giuseppe Rosiello More articles by this author Riccardo Leni More articles by this author Renzo Colombo More articles by this author Pierre I. Karakiewicz More articles by this author Francesco Montorsi More articles by this author Alberto Briganti More articles by this author Expand All Advertisement Loading ...

MP62-20 THE DETECTION OF A PI-RADS 4-5 LESION AT MULTIPARAMETRIC MRI BEFORE CONFIRMATORY BIOPSY IS THE STRONGEST PREDICTOR OF DISEASE PROGRESSION AMONG MEN WITH LOW-RISK PROSTATE CANCER INCLUDED IN AN ACTIVE SURVEILLANCE PROSPECTIVE PROTOCOL

You have accessJournal of UrologyProstate Cancer: Localized: Active Surveillance II (MP62)1 Sep 2021MP62-20 THE DETECTION OF A PI-RADS 4-5 LESION AT MULTIPARAMETRIC MRI BEFORE CONFIRMATORY BIOPSY IS THE STRONGEST PREDICTOR OF DISEASE PROGRESSION AMONG MEN WITH LOW-RISK PROSTATE CANCER INCLUDED IN AN ACTIVE SURVEILLANCE PROSPECTIVE PROTOCOL Luigi Nocera, Giorgio Gandaglia, Riccardo Leni, Armando Stabile, Elio Mazzone, Carlo Andrea Bravi, Giuseppe Rosiello, Giuseppe Cirulli, Donato Cannoletta, Lorenzo Toneatto, Simone Scuderi, Francesco Barletta, Francesco Pellegrino, Francesco De Cobelli, Francesco Montorsi, and Alberto Briganti Luigi NoceraLuigi Nocera More articles by this author , Giorgio GandagliaGiorgio Gandaglia More articles by this author , Riccardo LeniRiccardo Leni More articles by this author , Armando StabileArmando Stabile More articles by this author , Elio MazzoneElio Mazzone More articles by this author , Carlo Andrea BraviCarlo Andrea Bravi More articles by this author , Giuseppe RosielloGiuseppe Rosiello More articles by this author , Giuseppe CirulliGiuseppe Cirulli More articles by this author , Donato CannolettaDonato Cannoletta More articles by this author , Lorenzo ToneattoLorenzo Toneatto More articles by this author , Simone ScuderiSimone Scuderi More articles by this author , Francesco BarlettaFrancesco Barletta More articles by this author , Francesco PellegrinoFrancesco Pellegrino More articles by this author , Francesco De CobelliFrancesco De Cobelli More articles by this author , Francesco MontorsiFrancesco Montorsi More articles by this author , and Alberto BrigantiAlberto Briganti More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002102.20AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Although multiparametric magnetic resonance imaging (mpMRI) is commonly used in the diagnosis and staging of prostate cancer (PCa), its implications for patient selection and follow-up of active surveillance (AS) candidates is still controversial. METHODS: Patients with localized PCa enrolled in an AS protocol at a single tertiary referral center between 2010 and 2019 were identified. All underwent mpMRI before confirmatory biopsy (cBx) (n=294). AS was proposed to pts with grade group (GG) 1 PCa, all received a cBx within 12 months. Patients referred from other institutions underwent central pathology review. mpMRIs were evaluated according to PI-RADS v.2 criteria. The primary endpoint was disease progression, defined as GG >1 at follow-up Bx. Kaplan-Meier analyses assessed the impact of negative or equivocal mpMRI (PIRADS <4) performed before cBx on risk of progression. Uni- and multivariable Cox regression tested the effect of negative or equivocal mpMRI on progression after adjusting for confounders. Multivariable Cox models tested which characteristics were associated with progression in pts with positive mpMRI. RESULTS: Median age was 65.1 y (58.6–69.3), PSA 5.7 ng/mL (4.3–7.7), PSA density (PSAD) 0.11 ng/mL2 (0.07–0.15). Median follow-up was 22 months (8–47). Overall, 115 pts (36%) had a positive (PI-RADS ≥4) mpMRI before enrollment or during follow-up. Patients with negative or equivocal mpMRI scan were younger (64.5 vs 66.5 yrs, p=0.007), had lower PSA values (5.3 vs 6.1 ng/ml, p=0.01), larger prostate volumes (55 vs 45 ml, p=0.007) and lower PSAD (0.10 vs 0.13, p<0.001). No significant differences were recorded with respect to number of positive Bx cores at enrollment (median 1 vs 1, p=0.3). Men with negative or equivocal mpMRI scan had lower progression rates compared to pts with positive baseline or follow-up mpMRI (HR 0.35, p<0.001). This finding was corroborated in multivariable regression, after adjusting for age, PSA, prostate volume and number of positive cores (p<0.001). In subgroup analyses, among patients with positive mpMRI, those with a number of cores >16 exhibited lower risk of progression (HR: 0.5, p=0.02). CONCLUSIONS: Individuals with a PI-RADS 4-5 managed with AS should be considered at increased risk of progression and should receive a more stringent follow-up. In this scenario, a number of collected cores >16 appears to be key to reduce such risk given better assessment by more extensive Bx sampling. Source of Funding: None © 2021 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 206Issue Supplement 3September 2021Page: e1100-e1100 Advertisement Copyright & Permissions© 2021 by American Urological Association Education and Research, Inc.MetricsAuthor Information Luigi Nocera More articles by this author Giorgio Gandaglia More articles by this author Riccardo Leni More articles by this author Armando Stabile More articles by this author Elio Mazzone More articles by this author Carlo Andrea Bravi More articles by this author Giuseppe Rosiello More articles by this author Giuseppe Cirulli More articles by this author Donato Cannoletta More articles by this author Lorenzo Toneatto More articles by this author Simone Scuderi More articles by this author Francesco Barletta More articles by this author Francesco Pellegrino More articles by this author Francesco De Cobelli More articles by this author Francesco Montorsi More articles by this author Alberto Briganti More articles by this author Expand All Advertisement Loading ...

Progression-free survival in patients with 68Ga-PSMA-PET-directed SBRT for lymph node oligometastases

Background Prostate cancer oligometastatic disease can be treated using stereotactic body radiotherapy (SBRT) in order to postpone start of systemic treatments such as androgen deprivation therapy (ADT). 68Ga-PSMA-PET/CT imaging allows for diagnosis of oligometastases at lower PSA values. We analysed a cohort of patients with prostate cancer lymph node oligometastases detected on PSMA-PET/CT. Materials and methods Ninety patients with metachronous oligometastatic prostate cancer received SBRT for 1–3 lymph node metastases diagnosed on 68Ga-PSMA-PET/CT. The primary end point was progression free survival (PFS), with disease progression defined as occurrence of either target lesion progression, new metastatic lesion or biochemical progression. Secondary outcomes were biochemical PFS (BPFS), ADT-free survival (ADT-FS), toxicity and quality of life (QoL). Baseline patient characteristics were tested for association with PFS and a preliminary risk score was created. Results Median follow-up was 21 months (interquartile range 10–31 months). Median PFS and BPFS were 16 and 21 months, respectively. Median ADT-FS was not reached (73% (95%-CI 62–86%) at 24 months). In multivariable analysis, younger age, higher PSA prior to SBRT and extrapelvic location were associated with shorter PFS. Grade 1 fatigue was the most predominant acute toxicity (34%). Highest grade toxicity was grade 2 for acute and late events. QoL analysis showed mild, transient increase in fatigue at 1–4 weeks after SBRT. Conclusion A median PFS of 16 months was attained after SBRT for patients with PSMA-PET positive oligometastatic lymph nodes from prostate cancer. Higher pre-SBRT PSA, younger age and extrapelvic location were found to be predictors of shorter PFS.