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Purpose: We sought to evaluate the prognostic impact of prostate-specific antigen (PSA) at 6 months after completion of radiotherapy (RT) in patients treated with RT alone, RT plus short-term (st; 3-6 months), and RT plus long-term (lt; 24-36 months) androgen-deprivation therapy (ADT)., Patients and Methods: Individual patient data were obtained from 16 randomized trials evaluating RT ± ADT for localized prostate cancer (PCa) between 1987 and 2011. The lowest PSA recorded within 6 months after RT completion was identified and categorized as < or ≥0.1 ng/mL. The primary outcomes were metastasis-free survival (MFS), PCa-specific mortality (PCSM), and overall survival (OS), from 12 months after random assignment., Results: Ninety-eight percent (n = 2,339/2,376) of patients allocated to RT alone, 84% (n = 4,756/5,658) allocated to RT + stADT, and 77% (n = 1,258/1,626) allocated to RT + ltADT had PSA ≥0.1 ng/mL within 6 months after completing RT. PSA ≥0.1 ng/mL was associated with lower MFS and OS and higher PCSM among patients allocated to RT ± ADT (RT - MFS: hazard ratio [HR], 2.24 [95% CI, 1.21 to 4.16]; PCSM: subdistribution hazard ratio [sHR], 1.82 [0.51 to 6.49]; OS: HR, 1.72 [0.97 to 3.05]; RT + stADT - MFS: HR, 1.27 [1.12 to 1.44]; PCSM: sHR, 2.10 [1.52 to 2.92]; OS: HR, 1.26 [1.11 to 1.44]; RT + ltADT - MFS: HR, 1.58 [1.27 to 1.96]; PCSM: sHR, 1.97 [1.11 to 3.49]; OS: HR, 1.59 [1.27 to 1.99]). Five-year MFS rates among patients allocated to RT, RT + stADT, and RT + ltADT were 91% versus 79%, 83% versus 76%, and 87% versus 74%, respectively, based on PSA < or ≥0.1 ng/mL., Conclusion: PSA ≥0.1 ng/mL within 6 months after RT completion was prognostic for lt outcomes in patients treated with RT ± ADT for localized PCa. This can be used to counsel patients treated with RT ± ADT and in guiding clinical trial design evaluating novel systemic therapies with RT + ADT as well as (de)intensification strategies.

Purpose: Prostate cancer risk calculators incorporate many factors to evaluate an individual's risk for prostate cancer. We validated two common North American-based, prostate cancer risk calculators., Patients and Methods: We conducted a prospective, multi-institutional study of 2,130 patients who underwent a prostate biopsy for prostate cancer detection from five centers. We evaluated the performance of the Sunnybrook nomogram-based prostate cancer risk calculator (SRC) and the Prostate Cancer Prevention Trial (PCPT) -based risk calculator (PRC) to predict the presence of any cancer and high-grade cancer. We examined discrimination, calibration, and decision curve analysis techniques to evaluate the prediction models., Results: Of the 2,130 patients, 867 men (40.7%) were found to have cancer, and 1,263 (59.3%) did not have cancer. Of the patients with cancer, 403 (46.5%) had a Gleason score of 7 or more. The area under the [concentration-time] curve (AUC) for the SRC was 0.67 (95% CI, 0.65 to 0.69); the AUC for the PRC was 0.61 (95% CI, 0.59 to 0.64). The AUC was higher for predicting aggressive disease from the SRC (0.72; 95% CI, 0.70 to 0.75) compared with that from the PRC (0.67; 95% CI, 0.64 to 0.70). Decision curve analyses showed that the SRC performed better than the PRC for risk thresholds of more than 30% for any cancer and more than 15% for aggressive cancer., Conclusion: The SRC performed better than the PRC, but neither one added clinical benefit for risk thresholds of less than 30%. Further research is needed to improve the AUCs of the risk calculators, particularly for higher-grade cancer.

Objective: To gather a pooled database from six tertiary-care referral centres using salvage cryotherapy (SC) for locally recurrent prostate cancer, and develop a pretreatment nomogram allowing a prediction of the probability of biochemical failure after SC, based on pretreatment clinical variables., Patients and Methods: We retrospectively analysed 797 men treated at six tertiary-care referral centres with SC for locally recurrent disease after primary radiotherapy with curative intent. The median duration of follow-up from the time of SC to the date of last contact was 3.4 years. The primary study endpoint was biochemical failure, defined as a serum prostate-specific antigen (PSA) level after SC of >0.5 ng/mL., Results: Overall, the rate of biochemical failure was 66% with a median of 3.4 years of follow-up. A logistic regression model was used to predict biochemical failure. Covariates included serum PSA level at diagnosis, initial clinical T stage, and initial biopsy Gleason score. On the basis of these results, a pretreatment nomogram was developed which can be used to help select patients best suited for SC. Our pretreatment nomogram was internally validated using 500 bootstrap samples, with the concordance index of the model being 0.70., Conclusion: A pretreatment nomogram based on several diagnostic variables (serum PSA level at diagnosis, biopsy Gleason grade, and initial clinical T stage) was developed and might allow the selection of ideal candidates for SC.

Objectives: To report the 3‐year follow‐up of a Phase I study of magnetic resonance imaging (MRI)‐guided transurethral ultrasound ablation (TULSA) in 30 men with localised prostate cancer. Favourable 12‐month safety and ablation precision were previously described. Patients and Methods: As a mandated safety criterion, TULSA was delivered as near whole‐gland ablation, applying 3‐mm margins sparing 10% of peripheral prostate tissue in 30 men. After 12‐month biopsy and MRI, biannual follow‐up included prostate‐specific antigen (PSA), adverse events (AEs), and functional quality‐of‐life assessment, with repeat systematic biopsy at 3 years. Results: A 3‐year follow‐up was completed by 22 patients. Between 1 and 3 years, there were no new serious or severe AEs. Urinary and bowel function remained stable. Erectile function recovered by 1 year and was stable at 3 years. The PSA level decreased 95% to a median (interquartile range) nadir of 0.33 (0.1–0.4) ng/mL, stable to 0.8 (0.4–1.6) ng/mL at 3 years. Serial biopsies identified clinically significant disease in 10/29 men (34%) and any cancer in 17/29 (59%). By 3 years, seven men had recurrence (four histological, three biochemical) and had undergone salvage therapy without complications (including six prostatectomies). At 3 years, three of 22 men refused biopsy, and two of the 22 (9%) had clinically significant disease (one new, one persistent). Predictors of salvage therapy requirement included less extensive ablation coverage and higher PSA nadir. Conclusion: With 3‐year Phase I follow‐up, TULSA demonstrates safe and precise ablation for men with localised prostate cancer, providing predictable PSA and biopsy outcomes, without affecting functional abilities or precluding salvage therapy. [ABSTRACT FROM AUTHOR]

The article discusses a study which determined the long-term effect of vitamin E and selenium on risk of prostate cancer in relatively healthy men. Statistical analysis showed the significant increase in the risk of prostate cancer among healthy men who received vitamin E dietary supplements. According to data, 620 men in the vitamin E group and 575 men in the selenium group developed prostate cancer, compared with 529 men in the placebo group. Data indicate the frequency of use of prostate-specific antigen (PSA) and digital rectal examination, as well as the rate of prostate cancer detection in all the treatment groups.

Purpose: We assessed the efficacy of cryoablation of the prostate with an emphasis on finding predictive factors that lead to improved outcome. Materials and Methods: A total of 187 patients with locally recurrent prostate cancer after radiotherapy underwent salvage cryoablation of the prostate, and were studied after a mean followup of 39 months. Survival analysis was performed with the Kaplan-Meier method. Several variables were tested for predictive value using the Cox regression model including serum prostate specific antigen before radiotherapy, serum prostate specific antigen at cryoablation, clinical stage before radiotherapy, Gleason score before radiotherapy, Gleason score at cryoablation, number of positive biopsy cores and use of neoadjuvant hormonal therapy before cryoablation. Results: Serum prostate specific antigen at cryoablation was a predictive factor for biochemical recurrence on univariate and multivariate analysis (p <0.001). Patients with pre-cryoablation prostate specific antigen less than 4 ng/ml had a 5 and 8-year biochemical recurrence-free survival of 56% and 37%, respectively. In contrast, patients with pre-cryoablation prostate specific antigen 10 ng/ml or greater had a 5 and 8-year biochemical recurrence-free survival of only 1% and 7%, respectively. Patients with pre-cryoablation prostate specific antigen from 4 to 9.99 ng/ml had intermediate survival outcomes. Of the patients 32% were started on hormonal therapy for disease progression at a mean of 31 months postoperatively. Overall 5 and 8-year survival was 97% and 92%, respectively. Conclusions: Salvage cryoablation is a viable treatment option for patients with prostate cancer in whom radiation therapy has failed. Salvage cryoablation should be performed when serum prostate specific antigen is still relatively low because in these patients the procedure may potentially be curative. Even when cryoablation fails to eradicate the disease in some patients, it allows hormonal therapy to be deferred for a significant period of time in that cohort. [Copyright &y& Elsevier]

To assess the clinical outcome of patients with a diagnosis of high-grade prostatic intraepithelial neoplasia (PIN) on initial prostatic biopsy, with a minimum of 5 years of follow-up, as such patients are at greater risk of having prostate cancer on subsequent biopsy. Between November 1992 and October 1998, 21 patients were identified as having PIN on their initial transrectal ultrasonography-guided prostate biopsy. None of these patients had a focus of cancer on the initial biopsy. Their medical data were reviewed retrospectively to determine the natural history of PIN in these patients. Patients who were not identified as having cancer were followed every 6–12 months with prostate-specific antigen (PSA) testing and digital rectal examinations (DRE). A mean (range) of 7 (2–8) cores were taken at initial biopsy; the mean age of the patients was 63 (53–77) years and mean PSA level 9.1 (4.9–17.6) ng/mL. Six patients had an abnormal DRE at presentation. A mean of 8 (7–10) cores were obtained on the second biopsy; six patients were diagnosed with cancer, with a mean Gleason score of 6 (5–7), while three were diagnosed with persistent PIN. These three patients had a third prostate biopsy which showed cancer of Gleason score 6 in one and benign prostatic hyperplasia in two. After a mean follow-up of 72.2 (60–84) months, none of the remaining 12 patients was diagnosed with clinically significant cancer. Five of these patients went on to a third prostate biopsy, with no evidence of cancer. One patient died from unrelated causes during this period. This study affirms our current practice of following patients with PIN conservatively if a second or third subsequent prostate biopsy is negative. Whether PIN is a premalignant lesion or merely a lesion associated with cancer needs to be addressed in multicentre studies with a follow-up of > 10 years. [ABSTRACT FROM AUTHOR]

INTRODUCTION: Radiation therapy for prostate cancer is associated with a 15-20% five-year recurrence rate. Patients with recurrence in the prostate only are candidates for salvage local therapies; however, there is no consensus on modality. This study uses registries at Memorial Sloan Kettering Cancer Center (MSKCC) and University of Western Ontario (UWO) to compare the oncologic outcomes of salvage radical prostatectomy (SRP) and salvage ablation (SA). METHODS: A total of 444 patients were available for analysis. Due to intergroup differences, propensity score methodology was used and identified 378 patients with more comparable pre-salvage prostate-specific antigen (PSA), Gleason score, and primary radiation treatment. Patients underwent SRP at MSKCC and SA at UWO. RESULTS: Of the 378 patients, 48 died of disease, with a 6.0-year median (interquartile range [IQR] 3.0, 9.7) followup among survivors; 88 developed metastases, with a median 4.6-year (IQR 2.3, 7.9) followup among metastasis-free survivors. There was a non-significantly higher rate of cancer-specific (hazard ratio [HR] 1.02, 95% confidence interval [CI] 0.51, 2.06, p=0.9) and improved metastasis-free survival (HR 0.71, 95% CI 0.44, 1.13, p=0.15) among patients undergoing SA compared to patients undergoing SRP. There were 143 patients who received hormonal therapy, with higher rates of androgen deprivation therapy (ADT) in SA (HR 1.42, 95% CI 0.97, 2.08, p=0.068), although this did not meet conventional levels of significance. CONCLUSIONS: This propensity score analysis of salvage therapy for radio-recurrent prostate cancer identified no statistically significant differences in oncologic outcome between SRP and SA; however, there was evidence of a lower risk of ADT in the cohort undergoing SRP. Given they are both potentially curative therapies, these treatments are viable options for men with clinically localized, radio-recurrent prostate cancer rather than ADT alone. Future research may further elucidate subpopulations that may be more amenable to either SRP or SA. [ABSTRACT FROM AUTHOR]