Definitive Therapy For Prostate Cancer Research Articles

LBA02-09 EMBARK: A Phase 3 Randomized Study of Enzalutamide or Placebo Plus Leuprolide Acetate and Enzalutamide Monotherapy in High-risk Biochemically Recurrent Prostate Cancer

LBA02-09 EMBARK: A Phase 3 Randomized Study of Enzalutamide or Placebo Plus Leuprolide Acetate and Enzalutamide Monotherapy in High-risk Biochemically Recurrent Prostate Cancer

Changes in planned disease management after piflufolastat F18 PET/CT in men with biochemically recurrent prostate cancer and low PSA levels: A secondary analysis of results from the CONDOR study.

61 Background: Piflufolastat F 18 is a PSMA-targeted radiopharmaceutical approved in the US for imaging prostate cancer (PCa) patients both at the time of initial staging and at disease recurrence. In a phase 3 study of patients with biochemically recurrent (BCR) PCa, we reported that nearly two-thirds (63.9%; 131/205) of participants had a change in their intended disease management plan based on pre- and post-piflulfolastat F 18 PET/CT management questionnaires (MMQs) completed by the treating physicians. The clinical utility of piflufolastat F 18 scanning in men with very low/low PSA levels (<0.5 ng/mL) and a detection rate of ~36% has not been previously described. Here we report the changes in intended management in this subset of patients. Methods: Men ≥18 years of age with a rising PSA after definitive PCa therapy and negative or equivocal imaging were enrolled. A single ~9 mCi (333 MBq) dose of piflufolastat F 18 was administered followed by PET/CT from mid-thigh through skull vertex 1-2 hours later. Prior to scanning, the treating physicians completed a pre-PET MMQ to document the initial intended management plan for their patients based on available clinical information including baseline conventional imaging results. After PET, they completed a post-PET MMQ and recorded the management plan in light of PET findings. Treatment recommendations that differed from the pre-scan recommendations were reported as changes in the intended management plan. Results: 208 men (median PSA 0.8 ng/mL [range 0.17-98.45], n=202) underwent piflufolastat F 18-PET/CT. 200 evaluable patients had both a baseline PSA value and completed MMQs. Of 131 patients with a recorded change in intended management, 127 had an evaluable baseline PSA level. Of the 69 patients with baseline PSA levels ≤0.5ng/mL, 27 (39.1%) recorded a change in intended disease management based on positive (n=20) or negative (n=7) PET, including salvage local to systemic therapy (n=15); systemic to local therapy (n=3); observation to treatment (n=5); and treatment to observation (n=4). An additional 15 patients (21.7%) had recommended bidirectional change in management (e.g., salvage RT+ADT) and are excluded in this report. Specific treatment intensification/de-intensification plans are under investigation. Conclusions: The frequency of changes in intended disease management observed in BCR PCa patients with low baseline PSA levels (≤0.5ng/mL) was 39.1%. Both negative and positive PET/CT results impacted treatment recommendations and can provide useful and actionable information. Clinical trial information: NCT02981368 .

Inference of core needle biopsy whole slide images requiring definitive therapy for prostate cancer

BackgroundProstate cancer is often a slowly progressive indolent disease. Unnecessary treatments from overdiagnosis are a significant concern, particularly low-grade disease. Active surveillance has being considered as a risk management strategy to avoid potential side effects by unnecessary radical treatment. In 2016, American Society of Clinical Oncology (ASCO) endorsed the Cancer Care Ontario (CCO) Clinical Practice Guideline on active surveillance for the management of localized prostate cancer.MethodsBased on this guideline, we developed a deep learning model to classify prostate adenocarcinoma into indolent (applicable for active surveillance) and aggressive (necessary for definitive therapy) on core needle biopsy whole slide images (WSIs). In this study, we trained deep learning models using a combination of transfer, weakly supervised, and fully supervised learning approaches using a dataset of core needle biopsy WSIs (n=1300). In addition, we performed an inter-rater reliability evaluation on the WSI classification.ResultsWe evaluated the models on a test set (n=645), achieving ROC-AUCs of 0.846 for indolent and 0.980 for aggressive. The inter-rater reliability evaluation showed s-scores in the range of 0.10 to 0.95, with the lowest being on the WSIs with both indolent and aggressive classification by the model, and the highest on benign WSIs.ConclusionThe results demonstrate the promising potential of deployment in a practical prostate adenocarcinoma histopathological diagnostic workflow system.

Diagnostic Accuracy and Observer Agreement of the MRI Prostate Imaging for Recurrence Reporting Assessment Score.

Background Prostate cancer local recurrence location and extent must be determined in an accurate and timely manner. Because of the lack of a standardized MRI approach after whole-gland treatment, a panel of international experts recently proposed the Prostate Imaging for Recurrence Reporting (PI-RR) assessment score. Purpose To determine the diagnostic accuracy of PI-RR for detecting local recurrence in patients with biochemical recurrence (BCR) after radiation therapy (RT) or radical prostatectomy (RP) and to evaluate the interreader variability of PI-RR scoring. Materials and Methods This retrospective observational study included patients who underwent multiparametric MRI between September 2016 and May 2021 for BCR after RT or RP. MRI scans were analyzed, and a PI-RR score was assigned independently by four radiologists. The reference standard was defined using histopathologic findings, follow-up imaging, or clinical response to treatment. Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and accuracy were calculated to assess PI-RR performance for each reader. The intraclass correlation coefficient was used to determine interreader agreement. Results A total of 100 men were included: 48 patients after RT (median age, 76 years [IQR, 70-82 years]) and 52 patients after RP (median age, 70 years [IQR, 66-74 years]). After RT, with PI-RR of 3 or greater as a cutoff (assigned when recurrence is uncertain), diagnostic performance ranges were 71%-81% sensitivity, 74%-93% specificity, 71%-89% PPV, 79%-86% NPV, and 77%-88% accuracy across the four readers. After RP, with PI-RR of 3 or greater as a cutoff, performance ranges were 59%-83% sensitivity, 87%-100% specificity, 88%-100% PPV, 66%-80% NPV, and 75%-85% accuracy. The intraclass correlation coefficient was 0.87 across the four readers for both the RT and RP groups. Conclusion MRI scoring with the Prostate Imaging for Recurrence Reporting assessment provides structured, reproducible, and accurate evaluation of local recurrence after definitive therapy for prostate cancer. © RSNA, 2022 Online supplemental material is available for this article. See also the editorial by Haider in this issue. An earlier incorrect version appeared online. This article was corrected on May 11, 2022.

The fluciclovine (FACBC) PET/CT site-directed therapy of oligometastatic prostate cancer (Flu-BLAST-PC) trial.

TPS5099 Background: Patients with biochemical recurrence (BCR) after local definitive therapy for prostate cancer (PC) represent the largest group of patients alive with PC in the United States. For patients with BCR after both radical prostatectomy and radiation, no further definitive treatment options currently exist as standard of care. FACBC PET/CT is a next-generation imaging modality approved in 2016 for suspected PC recurrence based on elevated PSA levels following prior treatment. FACBC PET/CT allows for earlier detection at lower PSA levels of oligometastatic PC in patients who would otherwise be considered as having micro-metastatic disease. FACBC PET/CT may provide potential targets for site-directed therapy; however, it is unknown whether this approach leads to improvement in clinically relevant outcomes. Methods: Flu-BLAST-PC (ClinicalTrials.gov Identifier: NCT0417543) is a prospective, interventional study enrolling men with PC and BCR who have previously undergone both radical prostatectomy and adjuvant or salvage radiation to the prostatic fossa, with PSA ≥0.5 to < 10 ng/mL, PSA doubling time > 3 to < 18 months, and no radiographically detectable metastases by conventional CT and bone scan imaging. Enrolled patients undergo FACBC PET/CT imaging, and those with no PC metastases detected (Group 1) undergo observation with repeat FACBC PET/CT performed at PSA thresholds of > 2 and > 5 ng/mL, with eligibility for the trial ending at PSA ≥10 ng/mL if FACBC PET/CT remains negative. Those with 1-3 PC regions (defined as radiation fields) detected on FACBC PET/CT (Group 2) undergo site-directed therapy with surgery (e.g. lymphadenectomy) and/or radiation, as well as six months of systemic treatment with androgen deprivation therapy (ADT) and abiraterone acetate with prednisone. Patients with ≥4 PC regions detected on FACBC PET/CT (Group 3) undergo six months of ADT and abiraterone acetate with prednisone without any site-directed therapy. Patients initially in Group 1 who subsequently have PC metastases detected on repeat FACBC PET/CT imaging per protocol join Group 2 or Group 3 based on the number of PC regions involved. Given the long anticipated survival of patients with PC and BCR, the primary endpoint of the study is undetectable PSA ( < 0.2 ng/mL) rate in Group 2 at two years beyond study treatment, with secondary endpoints including the same outcome measure for Group 3, undetectable PSA rate two years after testosterone recovery from ADT in Groups 2 and 3, time to re-initiation of ADT, overall survival, and safety and tolerability. Assuming a null hypothesis of 15% undetectable PSA rate for patients with BCR two years after completing ADT and alternative hypothesis of improvement to 40% in Group 2, planned enrollment is 65 patients in Group 2. This will provide 90% power at the two-sided significance level of 0.05. Five patients have enrolled to date. Clinical trial information: NCT0417543.

Patterns of Recurrence, Detection Rates, and Impact of 18-F Fluciclovine PET/CT on the Management of Men With Recurrent Prostate Cancer

To evaluate the characteristics of FACBC PET/CT in detecting recurrent prostate cancer after radiation or prostatectomy. The secondary aim was to determine the impact of FACBC PET/CT on radiation treatment recommendations in men with biochemical recurrence postprostatectomy. This is a single center retrospective study of men who underwent an FACBC PET/CT for rising PSA after definitive prostate cancer therapy. Detection rates in men with recurrence following any definitive treatment were compared at different PSA levels and anatomical sites. Radiotherapy treatment recommendations for patients postprostatectomy based on conventional imaging findings were compared to recommendations based on FACBC PET/CT findings. A total of 103 men underwent imaging with FACBC PET/CT. 74.8% (77) had lesions consistent with sites of prostate cancer recurrence. At PSA thresholds of <1, 1-2, and >2 ng/mL lesions were detected in 35.5%, 63.6%, and 95.2% of patients respectively (P <.001). The most common site of recurrence was outside of the pelvis (37). Detection of extraprostatic or extrapelvic recurrence was observed in 45.5% of men in the PSA tertile <1ng/mL. FACBC PET/CT results led to changes to the recommended radiotherapy treatment plan in 44.1% (15/34) of men with recurrence following radical prostatectomy. FACBC PET/CT demonstrated increased detection of recurrent prostate cancer with increasing PSA levels. Most recurrences were found outside the pelvis. Results of FACBC PET/CT changed radiotherapy management decisions in men treated with prostatectomy, supporting its use in localizing sites of disease recurrence in men with prostate cancer.

Perspective Regarding “Prevalence and Predictors of Climacturia and Associated Patient/Partner Bother in Patients With History of Definitive Therapy for Prostate Cancer”

Perspective Regarding “Prevalence and Predictors of Climacturia and Associated Patient/Partner Bother in Patients With History of Definitive Therapy for Prostate Cancer”

Imaging assessment of local recurrence of prostate cancer after radical prostatectomy.

Definitive therapy for prostate cancer includes radical prostatectomy and radiation therapy. Treatment is elected based on patient preference, biological tumor factors, and underlying health. Post prostatectomy, men are surveyed for disease recurrence with serial PSA measurements, digital rectal exam, and imaging studies depending on nomogram predicted risk of local disease recurrence and distant metastasis. In men with rising PSA levels, pathologically incomplete surgical margins or, if symptoms of metastasis develop, imaging may be obtained to localize disease. In cases of known biochemical recurrence, imaging is used to target biopsy, to contour in salvage radiation therapy and to assess disease response. For local disease recurrence, the most commonly performed exams are pelvic MRI and transrectal US. CT can evaluate for lymph node metastasis, but is suboptimal in the evaluation of the prostatectomy bed. PET/CT and PET/MRI have been used successfully to evaluate for local disease recurrence. The PI-RADSv2.1 manual provides a risk level and lexicon for use in description of prostate carcinoma prior to prostatectomy, but does not address imaging features post-surgery. A detailed description of nodal, bony, and visceral metastasis is given elsewhere. This manuscript outlines the context in which appropriate imaging exams may be obtained and focuses on imaging findings concerning for local disease recurrence after prostatectomy on various imaging modalities including CT, US, MRI, and PET.

MP78-10 PREVALENCE OF AND RISK FACTORS FOR CLIMACTURIA IN PATIENTS WITH HISTORY OF DEFINITIVE THERAPY FOR PROSTATE CANCER

INTRODUCTION AND OBJECTIVE:Climacturia is an underreported complication of definitive therapy for prostate cancer (PCa); i.e. radical prostatectomy (RP) or radiation therapy (RT). We sought to iden...

LBA02-12 A MULTICENTER PHASE 3 STUDY OF PSMA-TARGETED 18 F-DCFPYL PET/CT IN MEN WITH BIOCHEMICALLY RECURRENT PROSTATE CANCER: RESULTS FROM THE CONDOR TRIAL

You have accessJournal of UrologyLate-Breaking Abstracts (LBA2)1 Apr 2020LBA02-12 A MULTICENTER PHASE 3 STUDY OF PSMA-TARGETED 18F-DCFPYL PET/CT IN MEN WITH BIOCHEMICALLY RECURRENT PROSTATE CANCER: RESULTS FROM THE CONDOR TRIAL Michael A. Gorin*, Barry A. Siegel, Steven P. Rowe, Lawrence Saperstein, Frédéric Pouliot, David Y. Josephson, Jeffrey Y.C. Wong, Austin R. Pantel, Steve Cho, Kenneth L. Gage, Morand Piert, Andrei Iagaru, Janet H. Pollard, Vivien Wong, Jessica Jensen, Nancy Stambler, Michael J. Morris, and Peter Carroll Michael A. Gorin*Michael A. Gorin* More articles by this author , Barry A. SiegelBarry A. Siegel More articles by this author , Steven P. RoweSteven P. Rowe More articles by this author , Lawrence SapersteinLawrence Saperstein More articles by this author , Frédéric PouliotFrédéric Pouliot More articles by this author , David Y. JosephsonDavid Y. Josephson More articles by this author , Jeffrey Y.C. WongJeffrey Y.C. Wong More articles by this author , Austin R. PantelAustin R. Pantel More articles by this author , Steve ChoSteve Cho More articles by this author , Kenneth L. GageKenneth L. Gage More articles by this author , Morand PiertMorand Piert More articles by this author , Andrei IagaruAndrei Iagaru More articles by this author , Janet H. PollardJanet H. Pollard More articles by this author , Vivien WongVivien Wong More articles by this author , Jessica JensenJessica Jensen More articles by this author , Nancy StamblerNancy Stambler More articles by this author , Michael J. MorrisMichael J. Morris More articles by this author , and Peter CarrollPeter Carroll More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000000958.012AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract Introduction: Improved diagnostics are needed to better inform the treatment of men with biochemically recurrent (BCR) prostate cancer (PCa). 18F-DCFPyL is a novel PET agent that selectively binds with high affinity to PSMA, a protein overexpressed in PCa cells. We report the performance of PSMA-targeted 18F-DCFPyL PET/CT in the detection of occult sites of disease in men with BCR. Methods: Men with negative or equivocal imaging (e.g., CT, MRI, bone scan, 18F-fluciclovine PET) and a rising PSA after definitive therapy for PCa were eligible. Patients underwent PET/CT imaging 1-2 hours after administration of 9 mCi (333 MBq) of 18F-DCFPyL. The primary endpoint was the correct localization rate (CLR), defined as the percentage of patients with 1:1 correspondence between =1 lesion identified by 18F-DCFPyL PET/CT and the composite standard of truth (SOT) of pathology, correlative imaging, or PSA response. 18F-DCFPyL PET/CT scans were evaluated by three independent, blinded, central imaging readers. SOT results were evaluated by a separate central reader panel or by assessment of PSA response. The a priori definition of trial success was an observed CLR for =2 central readers that exceeds the lower limit of the 95% confidence interval (CI) of 20%. Results: 208 men (median PSA 0.8 [range 0.2-98.4] ng/mL) underwent 18F-DCFPyL PET/CT, which was well tolerated with a single drug-related serious adverse event. Based on central imaging review, PET/CT detected at least one site of disease in 59-66% of patients. The study achieved its primary endpoint with respect to CLR, with the lower limit of the 95% CI for all readers being >77% (Table 1). Conclusions: 18F-DCFPyL PET/CT met the study’s primary endpoint with a CLR of =85% for occult sites of disease in men with BCR and negative or equivocal baseline conventional imaging. The high CLR was independent of SOT method and PSA level, supporting the use of 18F-DCFPyL PET in detecting occult disease which could lead to more informed treatment choices in men with recurrent or suspected metastatic PCa. NCT03739684 Source Of Funding: Progenics Pharmaceuticals, Inc. © 2020 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 203Issue Supplement 4April 2020Page: e1119-e1120 Advertisement Copyright & Permissions© 2020 by American Urological Association Education and Research, Inc.MetricsAuthor Information Michael A. Gorin* More articles by this author Barry A. Siegel More articles by this author Steven P. Rowe More articles by this author Lawrence Saperstein More articles by this author Frédéric Pouliot More articles by this author David Y. Josephson More articles by this author Jeffrey Y.C. Wong More articles by this author Austin R. Pantel More articles by this author Steve Cho More articles by this author Kenneth L. Gage More articles by this author Morand Piert More articles by this author Andrei Iagaru More articles by this author Janet H. Pollard More articles by this author Vivien Wong More articles by this author Jessica Jensen More articles by this author Nancy Stambler More articles by this author Michael J. Morris More articles by this author Peter Carroll More articles by this author Expand All Advertisement PDF downloadLoading ...

Prevalence and Predictors of Climacturia and Associated Patient/Partner Bother in Patients With History of Definitive Therapy for Prostate Cancer

BackgroundClimacturia is an under-reported complication of definitive therapy for prostate cancer (PCa) - that is, radical prostatectomy (RP) and/or radiation therapy (RT). AimWe sought to identify the prevalence and predictors of climacturia and associated patient/partner bother in patients with and without prior PCa treatment. MethodsWe analyzed a database of patients who presented to our Men's Health clinic and filled out a questionnaire related to sexual function and pertinent medical histories. The prevalence of climacturia and associated patient/partner bother in patients with/without prior RP/RT was calculated. Univariable and multivariable logistic regressions were performed to identify predictors associated with climacturia and patient/partner bother. OutcomesThe primary outcomes were the prevalence and predictors of climacturia and associated patient/partner bother in patients with/without history of definitive PCa treatment. ResultsAmong 1,117 patients able to achieve orgasm, 192 patients (17%) had prior history of definitive therapy for PCa (RP alone = 139 [72%]; RT alone = 22 [11%]; RP + RT = 31 [16%]). Climacturia was reported by 39%, 14%, 52%, and 2.4% of patients with history of RP alone, RT alone, RP + RT, and neither RP nor RT, respectively (P < .05 between all groups). 33 to 45 percent of patients with climacturia noted significant patient/partner bother. Factors significantly associated with climacturia were prior RP, prior RT, history of other prostate surgery, and erectile dysfunction, although erectile dysfunction was not significant on multivariable analysis. Significant reduction in climacturia prevalence was noted for patients who were ≥1 year out from RP, compared with patients who were <1 year out.Among patients with prior RP/RT, stress urinary incontinence was associated with increased risk of climacturia, whereas diabetes was associated with decreased risk. No factors were associated with patient/partner bother. Among patients with prior RP, nerve-sparing technique did not predict presence of climacturia but was associated with reduced patient/partner bother. Clinical translationGiven significant prevalence of climacturia and associated patient/partner bother, patients should be counseled on the risk of climacturia before undergoing RP/RT. Strengths and limitationsStrengths include the large study population and the focus on both RP and RT. Limitations include the facts that this is a single-institution study that primarily relies on patients’ subjective reporting and that the study population may not represent the general population. ConclusionsClimacturia affects a significant proportion of patients with history of RP/RT for PCa, and many patients and their partners find this bothersome.Jimbo M, Alom M, Pfeifer ZD, et al. Prevalence and Predictors of Climacturia and Associated Patient/Partner Bother in Patients With History of Definitive Therapy for Prostate Cancer. J Sex Med 2020;17:1126–1132.

134 Prevalence of Climacturia in Patients with History of Definitive Therapy for Prostate Cancer

134 Prevalence of Climacturia in Patients with History of Definitive Therapy for Prostate Cancer

Imaging of Prostate Specific Membrane Antigen Targeted Radiotracers for the Detection of Prostate Cancer Biochemical Recurrence after Definitive Therapy: A Systematic Review and Meta-Analysis.

Prostate specific membrane antigen targeted radiotracers are promising agents for imaging patients with prostate cancer biochemical recurrence after definitive therapy. We report the results of a systematic review and meta-analysis of the detection of biochemical recurrence after definitive therapy for prostate cancer stratified by prostate specific antigen levels and using prostate specific membrane antigen targeted radiotracers. According to the Preferred Reporting Items for Systematic reviews and Meta-Analysis Diagnostic Test Accuracy guidelines, we searched for articles in PubMed® and EMBASE® databases in our systematic review from 2012 to July 2018. Studies evaluating men with prostate cancer biochemical recurrence after definitive therapy and without known metastatic disease who underwent prostate specific membrane antigen positron emission tomography/computerized tomography to detect recurrent disease were included in analysis. The risk of bias and applicability concerns were assessed by QUADAS-2 (Quality Assessment of Diagnostic Accuracy Studies 2). Statistical heterogeneity was assessed with the Cochrane Q and an I2 estimate. The reference standard was pathology findings, followup imaging or a prostate specific antigen decline after salvage treatment. We calculated pooled estimates and the 95% CI around the prevalence of a positive examination in the study population using a random effects model. A total of 5,113 patients in 43 studies were included in this systematic review. Of the studies 15 (34.8%) were prospective, 3 (6.9%) were multi-institutional and the remainder were done at a single center. A total of 18 studies (41.8%) were done in subjects after radical prostatectomy, 2 (4.6%) were in subjects after radiotherapy and 23 (53.5%) were in subjects after radical prostatectomy and radiotherapy. Median prostate specific antigen was 1.6 ng/ml (IQR 0.7-4.4) and median subject age was 68 years (IQR 67-70). Of the 43 studies 33 (76.7%) evaluated 68Ga prostate specific membrane antigen-11 (Ga-HBED-CC) positron emission tomography/computerized tomography. The pooled detection rate was 70.2% (95% CI 65.0-75.4) in the entire cohort. For prostate specific antigen less than 0.5, 0.5 to 0.9, 1 to 1.9 and 2 ng/ml or greater the pooled detection rate was 44.9% (95% CI 36.0-53.9), 61.3% (95% CI 52.3-70.3), 78.2% (95% CI 70.8-85.6) and 93.9% (95% CI 92.0-95.8), respectively. A reference standard was confirmed to be positive in 684 of the 715 patients (95.7%). There were significant study heterogeneity and publication biases (p <0.01). Prostate specific membrane antigen targeted radiotracers are likely effective to detect biochemically recurrent prostate cancer at low prostate specific antigen levels. However, existing studies are limited by retrospective design, limited reference standards, publication bias and a lack of interagent comparison.

Worse Urinary, Sexual and Bowel Function Cause Emotional Distress and Vice Versa in Men Treated for Prostate Cancer

Definitive therapy for prostate cancer (eg surgery or radiotherapy) often has side effects, including urinary, sexual and bowel dysfunction. The purpose of this study was to test whether urinary, sexual and bowel functions contribute to emotional distress during the first 2 years after treatment and whether distress may in turn decrease function. The study participants were 1,148 men diagnosed with clinically localized disease who were treated with surgery (63%) or radiotherapy (37%). Urinary, sexual and bowel functions were assessed withEPIC (Expanded Prostate Cancer Index Composite). Emotional distress wasassessed with the NCCN® (National Comprehensive Cancer Network®) Distress Thermometer. Assessment time points were before treatment, and 6weeks, and 6, 12, 18 and 24 months after treatment. We used time lagged multilevel models to test whether physical function predicted emotional distress and viceversa. Men with worse urinary, bowel and sexual functions reported more emotional distress than others at subsequent time points. The relationships were bidirectional. Men who reported worse distress also reported worse urinary, bowel and sexual functions at subsequent time points. Clinicians supported by practice and payer policies should screen for and facilitate the treatment of side effects and heightened emotional distress to improve well-being in survivors of prostate cancer. These interventions may be cost-effective, given that emotional distress can negatively impact functioning across life domains.

Trends and Clinico-Sociodemographic Determinants of Stereotactic Body Radiation Therapy Use for Localized Prostate Cancer

Stereotactic body radiotherapy (SBRT) represents an emerging and cautiously guideline-approved definitive therapy option for prostate cancer, though long-term data on efficacy and toxicity is still pending. Herein, we sought to determine contemporary national SBRT trends and clinico-sociodemographic determinants associated with its use in prostate cancer. The National Cancer Data Base (NCDB) was queried to identify 181,544 patients diagnosed with localized prostate cancer from 2004-2012 who received external beam radiotherapy. Multivariable logistic regression adjusted for sociodemographic and clinical factors was used to identify independent determinants of SBRT use. Rate of SBRT use for localized prostate cancer increased from 0.05% in 2004 to 4.87% in 2012 (Ptrend<0.001). SBRT was more likely to be delivered at academic centers, to patients with Medicare, and to patients who were white, younger, healthier, from wealthier and more educated zipcodes, and who had lower risk disease features (all P<0.001). Relative to Whites, men from more affluent zipcodes, or men with low stage or grade prostate cancer, Blacks, Hispanics, and men from less affluent zipcodes and men with high stage or grade prostate cancer were less likely to receive SBRT after multivariable adjustment, with adjusted hazard ratios of 0.66, 0.35, 0.33, 0.07, and 0.21, respectively (all P<0.001). The absolute national rate of SBRT use as definitive therapy for prostate cancer has increased nearly 100-fold over the last decade. Men who are White, younger, healthier, from more affluent zipcodes and with favorable disease characteristics are more likely to receive an emerging form of radiotherapy with unknown long-term efficacy and toxicity.

Trends and clinico-sociodemographic determinants of stereotactic body radiotherapy use for localized prostate cancer: A National Cancer Database study.

e545 Background: Stereotactic body radiotherapy (SBRT) represents an emerging and cautiously guideline-approved definitive therapy option for prostate cancer, though long-term data on efficacy and toxicity is still pending. Herein, we sought to determine contemporary national SBRT trends and clinico-sociodemographic determinants associated with its use in prostate cancer. Methods: The National Cancer Data Base (NCDB) was queried to identify 181,544 patients diagnosed with localized prostate cancer from 2004-2012 who received external beam radiotherapy. Multivariable logistic regression adjusted for sociodemographic and clinical factors was used to identify independent determinants of SBRT use. Results: Rate of SBRT use for localized prostate cancer increased from 0.05% in 2004 to 4.87% in 2012 ( Ptrend&lt; 0.001). SBRT was more likely to be delivered at academic centers, to patients with Medicare, and to patients who were white, younger, healthier, from wealthier and more educated zipcodes, and who had lower risk disease features (all P&lt; 0.001). Relative to Whites, men from more affluent zipcodes, or men with low stage or grade prostate cancer, Blacks, Hispanics, and men from less affluent zipcodes and men with high stage or grade prostate cancer were less likely to receive SBRT after multivariable adjustment, with adjusted hazard ratios of 0.66, 0.35, 0.33, 0.07, and 0.21, respectively (all P&lt; 0.001). Conclusions: The absolute national rate of SBRT use as definitive therapy for prostate cancer has increased nearly 100-fold over the last decade. Men who are White, younger, healthier, from more affluent zipcodes and with favorable disease characteristics are more likely to receive an emerging form of radiotherapy with unknown long-term efficacy and toxicity.

S&T-27 STATINS AND BIOCHEMICAL RECURRENCE AND MORTALITY AFTER RADICAL PROSTATECTOMY OR RADIOTHERAPY: A SYSTEMATIC REVIEW AND META-ANALYSIS

You have accessJournal of UrologyScience & Technology Posters1 Apr 2016S&T-27 STATINS AND BIOCHEMICAL RECURRENCE AND MORTALITY AFTER RADICAL PROSTATECTOMY OR RADIOTHERAPY: A SYSTEMATIC REVIEW AND META-ANALYSIS Ping Tan, Shiyou Wei, Lu Yang, Liang Gao, Zhuang Tang, and Qiang Wei Ping TanPing Tan More articles by this author , Shiyou WeiShiyou Wei More articles by this author , Lu YangLu Yang More articles by this author , Liang GaoLiang Gao More articles by this author , Zhuang TangZhuang Tang More articles by this author , and Qiang WeiQiang Wei More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2016.02.2856AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES There is considerable interest in the potential ability of statins to improve prostate cancer outcomes after definitive therapy. We aim to further analysis of the association of statins use with biochemical recurrence and prostate cancer-specific mortality after definitive therapy for prostate cancer. METHODS A systematic literature search of PubMed, MEDLINE, and EMBASE through April 2015 was conducted using specific search terms. Pooled Hazard ratio (HR) estimates with corresponding 95% confidence intervals (CIs) were calculated using random-effects model. Publication bias and heterogeneity were evaluated before meta-analysis. STATA version 10 (Stata corporation, college station, TX) was employed to conduct all statistical analyses. RESULTS A total of 22 studies and 8 studies contributed to the PCa recurrence analysis and PCa-specific mortality, respectively. There was significant heterogeneity among studies but no publication bias. Overall, the combined result showed statins users had lowered 12% recurrence risk of PCa compared with non-users (HR=0.88, 95%CI: 0.765-0.998) (P<0.001) (Figure 1). The association was null among the men who underwent radical prostatectomy as primary therapy (HR=0.96, 95%CI: 0.83-1.09), while an inverse association was observed among patients received radiation therapy (HR=0.67, 95%CI: 0.48-0.86). Meanwhile, long-term statins use did not alter recurrence risk. There was 32% lower risk of prostate cancer-specific mortality among statins users (HR=0.68, 95%CI: 0.56-0.80). CONCLUSIONS Our meta-analysis provides evidence supporting the hypothesis that statins lower the recurrence risk of PCa after definitive treatment and significantly lower the risk of PCa-specific mortality. © 2016FiguresReferencesRelatedDetails Volume 195Issue 4SApril 2016Page: e319 Advertisement Copyright & Permissions© 2016MetricsAuthor Information Ping Tan More articles by this author Shiyou Wei More articles by this author Lu Yang More articles by this author Liang Gao More articles by this author Zhuang Tang More articles by this author Qiang Wei More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...

Relationship of phosphodiesterase type 5 inhibitor to biochemical recurrence after definitive therapy for prostate cancer.

119 Background: Phosphodiesterase type 5 inhibitors (PDE5i) are commonly utilized among men receiving definitive treatment for prostate cancer (PCa). Recently, contradictory clinical evidence regarding the association between biochemical recurrence (BCR) and receipt of PDE5i has been reported. We aimed to clarify this question among a multi-center, cohort of men with PCa. Methods: Participants enrolled in Cancer of the Prostate Strategic Urologic Research Endeavor (CaPSURE) at diagnosis and received radical prostatectomy, RP, or radiation therapy, RT (external beam radiation therapy or brachytherapy) without androgen deprivation therapy ≤ 6 months. We examined associations between clinical, Prostate Cancer Index Sexual Function score, SF (0-100 (best)), and pathological characteristics as well as baseline, time-dependent and ever-use of PDE5i (patient or physician reported) with risk of BCR using descriptive analyses, Kaplan-Meier method, and multivariate Cox proportional hazards models. Results: A total of 4,844 men were identified (3,847 RP, 997 RT.) Men received RP at median age 61 years (IQR 56-66), had a mean baseline SF score 62.4 (SD 26.7), were followed for a median of 77 months (IQR 36-117), and 3,089 (80%) were prescribed or reported use of PDE5i post-operatively. Patients treated with RT were older with a median age 69 years (IQR 63-74) and mean baseline SF score 46.6 (SD 29.5), were followed for a median of 91 months (IQR 53-125), and had lower rates of reported PDE5i usage (421 men, 42%). In Cox regression models baseline use (HR = 0.9 (95% CI 0.3-2.4) p = 0.83) and ever-usage (HR = 0.7 (0.5-1.1) p = 0.73) of PDE5i were not independently associated with BCR after RP. Time-dependent use (HR 1.3 (0.6, 2.7) p = 0.45) also was not associated with BCR after RP among men taking PDE5i medications. Baseline (HR = 4.6 (0.6-37.3) p = 0.14) and ever-usage (HR 0.6 (0.3-1.5) p = 0.30) also were not associated with BCR after RT. This study was limited by incomplete data on prescription compliance. Conclusions: PDE5i usage following RP or RT for PCa was not associated with BCR. PDE5i therapy should not be withheld due to concerns that it increases the risk of disease recurrence.

Abstract B147: Randomized phase II trial of a DNA vaccine encoding prostatic acid phosphatase (PAP) in patients with recurrent prostate cancer (NCT01341652)

Abstract Background: Patients with rapidly rising PSA alone after definitive therapy for prostate cancer are at high risk for metastatic progression and ultimately death from prostate cancer. This is a stage of disease for which there are no standard therapies, although androgen deprivation is often used. We have previously reported that a DNA vaccine encoding PAP (pTVG-HP) was safe and could elicit antigen-specific CD4+ and CD8+ T cells in this population (NCT00582140). Patients who developed persistent Th1-type immunity tended to have favorable changes in serum PSA doubling time. The safety, immunological activity, and changes in PSA doubling time were observed in a second pilot clinical trial evaluating different schedules of administration (NCT00849121). Methods: 106 patients with high-risk PSA-recurrent prostate cancer, PSA doubling time &amp;lt; 12 months, and no metastases by standard radiographic imaging, are being randomized to DNA vaccine with GM-CSF adjuvant versus GM-CSF adjuvant alone in this multicenter trial (NCT01341652). The primary endpoint is 2-year radiographic progression-free survival (PFS). Secondary and exploratory endpoints include median PFS, predictive and early response immune biomarkers, association of T-cell immunity with PFS, and change in tumor growth rates as measured by PSA and quantitative bone imaging using NaF PET imaging. Results: To our knowledge, this is the first randomized, phase II trial using an anti-tumor DNA vaccine. Enrollment is ongoing, but expected to be complete in 2015. The clinical and biomarker plan of evaluation will be presented, as well as descriptions of other pilot clinical trials ongoing with this DNA vaccine. Citation Format: Douglas G. McNeel, Lawrence Fong, Emmanuel S. Antonarakis, Glenn Liu. Randomized phase II trial of a DNA vaccine encoding prostatic acid phosphatase (PAP) in patients with recurrent prostate cancer (NCT01341652). [abstract]. In: Proceedings of the CRI-CIMT-EATI-AACR Inaugural International Cancer Immunotherapy Conference: Translating Science into Survival; September 16-19, 2015; New York, NY. Philadelphia (PA): AACR; Cancer Immunol Res 2016;4(1 Suppl):Abstract nr B147.

Radiotherapy for isolated lymph node metastases in patients with locally advanced prostate cancer after primary therapy.

To evaluate the outcome of radiotherapy for isolated lymph node metastases in patients with progression towards castration-resistant prostate cancer (CRPC) after definitive therapy. Between 11/2009 and 06/2014, 18 patients with isolated lymph node metastases after definitive prostate cancer therapy received radiotherapy to the affected lymph nodes with a total dose of 50.4 or 54.0Gray (Gy). All patients had continuously rising levels of PSA despite androgen deprivation therapy (ADT). Biochemical progression-free survival (BPFS), clinical failure-free survival (CFFS) and freedom from local failure were assessed, as was the toxicity profile. Of the 18 patients, 17 had high-risk prostate cancer. Radiotherapy was performed at a median interval of 64.55 [interquartile range (IQR) 23.2-153.8] months after definitive therapy. ADT was administered for a median (IQR) time of 3.8 (3.2-24.7) months prior to irradiation. The median (IQR) follow-up was 15.59 (5.3-28.5) months with 94.1% freedom from local failure. The median BPFS and CFFS were 5.85 (IQR 3.0-20.3) and 9.60months (IQR 5.9-28.8), respectively. No grade III acute or grade II late toxicity was observed. Only two patients developed local relapse. No patients exhibited deterioration of urinary or faecal continence. Radiotherapy of isolated lymph node metastases in patients who develop CRPC provides effective local control, is not associated with clinically important acute or long-term side effects, improves PSA kinetics and may delay the necessity of chemotherapy.