A Phase 2 Randomized Pilot Study Comparing High-Dose-Rate Brachytherapy and Low-Dose-Rate Brachytherapy as Monotherapy in Localized Prostate Cancer

Abstract

PurposeTo compare health-related quality of life (HRQOL) of high-dose-rate brachytherapy (HDRB) versus low dose-rate brachytherapy (LDRB) for localized prostate cancer in a multi-institutional phase 2 randomized trial.Methods and MaterialsMen with favorable-risk prostate cancer were randomized between monotherapy brachytherapy with either Iodine-125 LDRB to 144 Gy or single-fraction Iridium-192 HDRB to 19 Gy. HRQOL and urinary toxicity were recorded at baseline and at 1, 3, 6, and 12 months using the Expanded Prostate Cancer Index Composite (EPIC)-26 scoring and the International Prostate Symptom Score (IPSS). Independent samples t test and mixed effects modeling were performed for continuous variables. Time to IPSS resolution, defined as return to its baseline score ±5 points, was calculated using Kaplan-Meier estimator curves with the log-rank test. A multiple-comparison adjusted P value of ≤.05 was considered significant.ResultsLDRB and HDRB were performed in 15 and 16 patients, respectively, for a total of 31 patients. At 3 months, patients treated with LDRB had a higher IPSS score (mean, 15.5 vs 6.0, respectively; P = .003) and lower EPIC urinary irritative score (mean, 69.2 vs 85.3, respectively; P = .037) compared with those who received HDRB. On repeated measures at 1, 3, 6, and 12 months, the IPSS (P = .003) and EPIC urinary irritative scores (P = .019) were significantly better in the HDR arm, translating into a lower urinary toxicity profile. There were no significant differences in the EPIC urinary incontinence, sexual, or bowel habit scores between the 2 groups at any measured time point. Time to IPSS resolution was significantly shorter in the HDRB group (mean, 2.0 months) compared with the LDRB group (mean, 6.0 months; P = .028).ConclusionsHDRB monotherapy is a promising modality associated with a lower urinary toxicity profile and higher HRQOL in the first 12 months compared with LDRB.

Building a High-Dose-Rate Prostate Brachytherapy Program With Real-Time Ultrasound-Based Planning: Initial Safety, Quality, and Outcome Results

“…Acute urinary retention rate in our cohort was 2.4%, comparable with 1% to 20% reported in the literature. [11][12][13][14][15] Although the follow-up remained short, the estimated 3-year DFS and OS were also comparable with reported studies. 5 In the beginning, the procedure took about 3 hours to complete to meet dosimetric parameters of quality implantation.…”

“…With its advantages of precise dosimetry, no radiation exposure to the providers and to a lesser degree to the patients compared with permanent seed implants, high-dose-rate (HDR) prostate brachytherapy offers a compelling alternative option. [9][10][11][12][13] Because HDR brachytherapy has been used to treat other malignancies, especially gynecologic cancers, many institutions have an HDR program. Expanding its role to prostate cancer treatment maximizes the usage of existing resources, thus reducing the overall cost of maintaining an active HDR program.…”

High-dose-rate brachytherapy with external beam radiotherapy versus low-dose-rate brachytherapy with or without external beam radiotherapy for clinically localized prostate cancer

“…HDR-BT treated more advanced cases than LDR-BT in our cohort. Several retrospective studies 14 – 16 and a few preliminary and premature prospective studies have reported benefits of HDR-BT 17 – 19 .…”

Low dose rate brachytherapy for primary treatment of localized prostate cancer: A systemic review and executive summary of an evidence-based consensus statement

“…Two randomized controlled trials compared urinary quality of life between I-125 brachytherapy and single fraction HDR monotherapy (19-21 Gy x 1) (Table A ( 58 ). In another trial of 100 patients from Agoston et al , LDR brachytherapy was associated with greater IPSS scores at 3 months, but not at 12 months ( 59 ).…”