Prostate Study
Description
Objectives: To report the initial differences for high dose image guided radiation with or without androgen deprivation (AD). Material and methods: From 2012 to 2014, 116 patients were treated with or without 6 months of AD in our phase III randomized trial for intermediate-risk prostate cancer. The primary end points of the current analysis are early changes in the Expanded Prostate Cancer Index Composite (EPIC) scores, differences in the International Prostate Symptom Score (IPSS) scores, and bowel or urinary adverse events (AEs, graded using CTCAE v4) with and without AD. 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 AD. 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 (p=0.17) or chronic (p=0.68) urinary and acute (p=0.99) or chronic (p=0.99) bowel toxicities were similar with or without AD. Overall grade 3 urinary AEs were seen in 0.8% (1/116) of cases and no grade 3 bowel AEs were seen. With the use of AD, 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 AD or associated with the use of brachytherapy. Conclusions: Low toxicity and minimal temporary bother were seen in both arms. AD was well-tolerated and associated with temporary changes.