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OBJECTIVE. The purpose of this study was to determine the diagnostic accuracy of 68 Ga-labeled prostate-specific membrane antigen 11 (PSMA-11) PET for disease detection in patients with prostate cancer who have biochemically recurrent disease after radiation therapy or prostatectomy. SUBJECTS AND METHODS. One hundred fifty patients underwent 68 Ga-PSMA-11 PET/CT or PET/MRI, and the images were interpreted by two blinded board-certified radiologists. Each reader evaluated for the presence or absence of PSMA-positive disease within the prostate bed, pelvic lymph nodes, bones, and soft tissues (extrapelvic lymph nodes and visceral structures). The presence or absence of disease was confirmed by histopathologic analysis if available. For patients who did not have pathologic analysis, a composite of imaging and clinical follow-up was used as the reference standard. RESULTS. The median prostate-specific antigen level was 2.1 ng/mL. Forty-three patients had pathologic correlation, and for 29 patients a composite of imaging and follow-up was used to determine the presence or absence of disease. With substantial to almost perfect interreader reliability by region (κ = 0.78-0.87), 68 Ga-PSMA-11 PET had high sensitivity per region (up to 100%) and per patient (up to 89.8%). It also had high positive predictive value per region (up to 100%) and per patient (up to 91.5%). Sensitivity was highest for bone metastases and lowest for soft-tissue metastases. Positive predictive value was highest for bone metastases and lowest for prostate bed recurrence. CONCLUSION. Gallium-68-labeled PSMA-11 PET is sensitive for prostate cancer metastases in patients with biochemically recurrent prostate cancer. It has high positive predictive value and substantial to almost perfect interrater reliability.

The purpose of this prospective study was to estimate the effect of 68 Ga-labeled prostate-specific membrane antigen (PSMA)-11 PET on the intended management of patients with biochemically recurrent prostate cancer. Methods: Pre- and postimaging surveys were filled out by the referring providers for patients with biochemical recurrence who were imaged using 68 Ga-PSMA-11 PET. The inclusion criterion for this study was a prostate-specific antigen (PSA) doubling time of less than 12 mo after initial treatment (NCT02611882). Of the 150 consecutive patients imaged, 126 surveys were completed (84% response rate). The responses were categorized as major change, minor change, no change, or unknown change. Results: There were 103 patients (82%) with disease detected on 68 Ga-PSMA-11 PET. On the basis of the survey results, there were 67 patients (53.2%) with major changes in management and 8 patients (6.4%) with minor changes. The proportion of cases resulting in a change in management did not significantly differ by baseline PSA level. In patients with PSA levels below 0.2 ng/dL, 7 of 12 patients had disease detected on 68 Ga-PSMA-11 PET, 5 of whom had a major change in management. Conclusion: 68 Ga-PSMA-11 PET resulted in a major change in management in 53% of patients with biochemical recurrence. Further studies are warranted to investigate whether PSMA-based management strategies result in improved outcomes for patients., (© 2017 by the Society of Nuclear Medicine and Molecular Imaging.)

Purpose: Little is known about patterns of local failure following radiation therapy for prostate cancer. We aimed to characterize post-radiation biopsy findings, including the treatment effect and the zonal distribution of recurrent disease after radiation therapy, in men experiencing biochemical recurrence., Materials and Methods: We identified patients who received post-radiation biopsy in the setting of biochemical recurrence following primary radiation for localized disease. Histological post-radiation biopsy results were categorized by the absence of tumor, demonstration of radiation treatment effect, failure (recurrent cancer) or a combination of treatment effect and failure. We described patterns of histological failure and compared them to the diagnostic biopsy findings., Results: A total of 284 men underwent mapped post-radiation biopsy for biochemical recurrence. Mean age at initial diagnosis was 63 years and median prostate specific antigen was 8.2 ng/ml. Of the men 33%, 32% and 35% were classified at low, intermediate and high risk based on clinical CAPRA (Cancer of the Prostate Risk Assessment) categories. Median time to post-radiation biopsy was 61 months after treatment. Findings were negative in 4% of cases while we noted a treatment effect in 31%, failure in 45% and a combination in 20%. Failure rates were similar across sextants. Of 140 patients with mapped pretreatment and posttreatment biopsies 4% demonstrated cancer in a new location previously identified as negative. Gleason upgrading occurred in 43% of cases with 85% upgraded to 4 + 3 or higher., Conclusions: Men with rising prostate specific antigen after radiotherapy for prostate cancer most often experience recurrence in dominant tumor sites. Whether failure is due to inadequate targeting, dosing or intrinsic radiation resistance remains unknown to our knowledge. Further study is warranted., (Copyright © 2015 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.)

Purpose: Prostate cancer biopsy information is important for patient risk assessment. Although the number and extent of positive biopsies have been used to predict recurrence, the impact of positive biopsy location and contiguity is less clear. We compared the ability of positive prostate biopsy location and pattern with number and percent positive biopsies to predict recurrence after RP., Materials and Methods: From CaPSURE we identified 2,037 men treated with RP from 1992 to 2002 for whom detailed biopsy information and 2 or more followup PSA values were available. Treatment failure was defined as 2 consecutive PSA values of 0.2 ng/ml or higher, or a second treatment delivered more than 6 months after RP. Biopsy tumor volume (number and percent positive sites), location of disease (anatomical site, laterality), and contiguity of positive biopsies were entered into Cox proportional hazards models to predict risk of disease recurrence while controlling for Gleason grade, PSA and T stage., Results: Higher number and percent of positive biopsy cores were associated with prostate cancer recurrence, risk stratification category and Gleason grade, p <0.0001, HR 1.09 (CI 1.02 to 1.16) and 1.01 (CI 1.00 to 1.01), respectively. Number of biopsy cores taken, laterality, contiguity and positive biopsy location were not associated with disease recurrence., Conclusions: The number and the percentage of biopsies positive for cancer correlated with treatment failure after radical prostatectomy. Contiguity, laterality and location were not associated with recurrence.

Purpose: The Kattan preoperative nomogram combines preoperative prostate specific antigen (PSA), biopsy Gleason grade and clinical stage to estimate disease recurrence after radical prostatectomy. Several studies using patient data from academic centers have validated the nomogram. We assessed the performance of the Kattan nomogram using the Cancer of the Prostate Strategic Urological Research Endeavor database, a national, largely community based observational disease registry., Materials and Methods: From the Cancer of the Prostate Strategic Urological Research Endeavor database we identified 1701 men with clinically localized prostate cancer undergoing radical prostatectomy with sufficient pretreatment information and PSA followup after surgery. Disease recurrence was defined as 2 consecutive PSA values 0.2 ng/ml or greater, or a second cancer treatment more than 6 months after prostatectomy. A concordance index was used to evaluate the performance of the nomogram compared to observed 5-year recurrence-free survival (Kaplan-Meier). Kattan nomogram scores were calculated for each patient and stratified into 6 groups for analysis., Results: In our cohort of 1701 men 413 (24%) had evidence of disease recurrence. Median followup in these patients was 2.3 years. Kattan nomogram scores were 17% to 99% (mean 79%). The overall concordance index was 0.68. Varying the definition of recurrent disease and excluding patients with imputed data did not substantially alter nomogram performance (concordance index 0.65 to 0.70). The Kattan nomogram tended to overestimate 5-year freedom from recurrence in patients with scores of 65% and higher., Conclusions: We noted the reasonable performance of the Kattan nomogram for predicting cancer outcomes after radical prostatectomy using a community based population. Although concordance is lower than in previous validation studies and the nomogram overestimates recurrence-free survival in patients at lower risk, the model is fairly robust and it provides important information when counseling patients regarding treatment options in the community setting. Further refinements in pretreatment estimation of disease-free survival and ultimately overall survival are needed.