Initial results of a randomized phase III trial of high dose image guided radiation with or without androgen deprivation therapy for intermediate-risk prostate cancer.

BACKGROUND: Prior randomized studies have shown a survival benefit using combined androgen deprivation therapy (ADT) and radiation therapy for intermediate-risk prostate cancer. However, these studies either used low doses of radiation (66.6 Gy to isocenter) or imaged guidance was not available. This study reports the initial differences for high dose image guided radiation with or without ADT. METHODS: From 2012 to 2014, 56 patients were treated with and 60 patients without 6 months of ADT (N = 116) in our phase III randomized trial for intermediate-risk prostate cancer. The primary endpoints of the current analysis are Expanded Prostate Cancer Index Composite (EPIC) scores, International Prostate Symptom Score (IPSS) scores, and bowel or urinary adverse events (AEs, graded using CTCAE v4) with and without ADT. Treatment consisted of 81 Gy in 45 treatments (tx) or 100 Gy Pd-103 implant followed by 45 Gy in 25 tx with or without ADT. Cone-beam fiducial-based guidance was done. Statistical analysis included Fisher's exact test, chi-square test, and ANCOVA. RESULTS: Median follow-up for both groups was 2.6 years. Acute or chronic urinary and acute or chronic bowel toxicities were similar with or without ADT (acute urinary: 16 vs 25 G0-1, 39 vs 35 G2 and 1 vs 0 G3, p = 0.17; chronic urinary: 40 vs 45 G1 and 16 vs 15 G2 toxicities, p = 0.68; acute bowel: 56 vs 59 G1 and 0 vs 1 G2 toxicities, p = 0.99; chronic bowel: 56 vs 59 G1 and 0 vs 1 G2 toxicities, p = 0.99). One patient had grade 3 urinary AE (1/116 or 0.8%). No patient had grade 3 bowel AE. With the use of ADT, a temporary decline in the EPIC sexual (p = 0.004) and hormonal scores (p = 0.02) were seen for the first 3 to 6 months after the completion of radiation, but the scores recovered by 12 months. Brachytherapy plus external beam radiation was compared to external beam radiation alone; brachytherapy EPIC urinary irritative scores were temporarily lower at 3 months, 76 vs. 84 (p = 0.006), had higher IPSS scores at 3 months, 15 vs 12 (p = 0.01), and had increased acute urinary AEs (p<0.001). No difference in failures were seen with or without ADT or associated with the use of brachytherapy. SIGNIFICANCE: Low toxicity and minimal temporary bother as measured by EPIC and IPSS were seen in both arms. ADT was well-tolerated and associated with temporary changes.

Study characteristics of abstracts presented at the annual meetings of the southeastern section of the American Urological Association (1996-2005).

PURPOSE: We determined study characteristics, authorship and institutional origin of studies presented in abstract form at the Southeastern Section of the American Urological Association annual meetings and identified predictors of full text publication. MATERIALS AND METHODS: All abstracts of poster and podium presentations from the Southeastern Section of the American Urological Association annual meetings from 1996 to 2005 were reviewed. A standardized evaluation form was developed and tested in 2 subsets of 50 abstracts, and then applied by 2 individual reviewers with specific coding instructions. Predictor variables analyzed included study origin, design, topic, domain, presentation form, number of patients, reporting of statistical analysis and gender. Univariate and multivariate analysis was applied using SPSS version 14.0. RESULTS: A total of 1,195 abstracts were found eligible for review. The mean number of abstracts presented per year was 120 +/- 16 (range 107 to 146). In clinical studies (1,068) approximately three-quarters of the abstracts reported case series (801, 75.0%). Cohort studies accounted for 11.2% of the abstracts and 4.0% were randomized controlled trials or systematic reviews/meta-analyses. Median followup was 64 months (range 17 to 126) and the overall publication rate was 33.5%. First and senior female authorship were identified in 6.2% (74) and 5.4% (64) of abstracts presented, respectively. CONCLUSIONS: A majority of studies presented at the Southeastern Section of the American Urological Association annual meetings continue to represent small case series that may not be well suited to guide clinical decision making. Only a third of studies are subsequently published in the peer reviewed literature. The percentage of abstracts with female authorship remains low suggesting that increased efforts to involve women in urological research are indicated.

Outcomes of men who present with elevated serum PSA (>20 ng/mL) to an inner-city hospital.

INTRODUCTION: We report the incidence, clinicopathologic features, and outcomes of men who presented to an inner-city hospital with serum PSA >20 ng/ml. MATERIALS AND METHODS: Five-hundred-sixty men underwent a transrectal ultrasound needle-guided biopsy of the prostate for elevated PSA >4 ng/ml with or without an abnormal digital rectal examination. RESULTS: Of the 560 men, 65 (12%) were found to have a serum PSA >20 ng/ml, and 57 (10%) were diagnosed with prostate cancer. In the group of 57 men with cancer, the positive predictive value of PSA alone was 72% for PSA levels of 20-29.99 ng/ml and 100% for PSA >30 ng/ml. Of the 57 men, 18 underwent definitive therapy, 24 underwent androgen deprivation, 8 refused treatment or were lost to follow-up, and 7 were treated on protocol. An additional seven men with cancer refused therapy or were lost to follow-up, thus giving a total of 15 (26%) men who were noncompliant to medical advice. CONCLUSIONS: Serum PSA >30 ng/ml is an almost certain predictor of the presence of prostate cancer. Aggressive prostate cancer education and screening programs are needed in our inner cities in order to detect prostate cancer at an earlier, treatable stage.