Dataset Information

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

ABSTRACT: Purpose:To 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 Materials:Men 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. Results:LDRB 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). Conclusions:HDRB monotherapy is a promising modality associated with a lower urinary toxicity profile and higher HRQOL in the first 12 months compared with LDRB.

SUBMITTER: Hathout L

PROVIDER: S-EPMC6817536 | biostudies-literature | 2019 Oct-Dec

REPOSITORIES: biostudies-literature

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

Hathout Lara L Mahmoud Omar O Wang Yaqun Y Vergalasova Irina I Barkati Maroie M Després Philippe P Martin André-Guy AG Foster William W Lacroix Frédéric F Delouya Guila G Taussky Daniel D Morton Gerard G Vigneault Eric E

Advances in radiation oncology 20190418 4

<h4>Purpose</h4>To 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.<h4>Methods and materials</h4>Men 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, ...[more]

PMID: 31673656

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Project description:BACKGROUND:The objective of focal brachytherapy (BT) is to provide effective prostate cancer control for low-risk disease but with reduced genitourinary, gastrointestinal and sexual side effects in a cost-effective way. OBJECTIVE:The aim of this study is to describe a phase II study examining technical and dosimetric feasibility and toxicity, quality of life changes, and local control with post-treatment biopsy outcomes in men with early stage low volume prostate cancer treated with focal iodine-125 seed BT. METHODS:The study design is a prospective, multicenter trial with a planned sample size of 20 patients including men with a minimum age of 60 years, a life expectancy estimated to be greater than 10 years, with low or low-tier intermediate risk prostate cancer, unilateral disease on the biopsy, and a Gleason score of ?3+4 and <25% cores involved. The investigations specific for the study are multi-parametric magnetic resonance imaging (Mp-MRI) baseline, at 20 and 36 months to rule out high grade disease and a transperineal mapping biopsy (baseline and at 36 months) for more accurate patient selection. The hemigland region will receive 144 Gy. Standard normal tissue constraints will be considered as for a whole gland (WG) implant. Dosimetric parameters will be evaluated at day 30 after the implant. Toxicity and quality of life will be evaluated with international validated questionnaires focusing on urinary, rectal, sexual domain, and general health-related quality of life. The patients will complete this assessment at baseline and then approximately every 6 months after the implant up to 10 years. RESULTS:To date, one patient is involved in the trial. He underwent the pre-implant investigations which found bilateral disease. Therefore, a standard seed implant was performed. If the results from this trial provide evidence that the treatment is safe, feasible, and improves toxicity, funding will be sought to conduct a large, multicenter, randomized controlled trial (RCT). CONCLUSIONS:This protocol is designed to show feasibility in delivering hemigland focal therapy with seed BT. It may answer crucial questions and obtain data which will enable downstream decisions on focal low dose rate (LDR) prostate BT. CLINICALTRIAL:Clinicaltrial.gov NCT02643511; https://www.clinicaltrials.gov/ct2/show/NCT02643511 (Archived by Webcite at http://www.webcitation.org/6ghLCzIhY).

Project description:MIM Symphony is a recently introduced low-dose-rate prostate brachytherapy treatment planning system (TPS). We evaluated the dosimetric and planning accuracy of this new TPS compared to the universally used VariSeed TPS. For dosimetric evaluation of the MIM Symphony version 5.4 TPS, we compared dose calculations from the MIM Symphony TPS with the formalism recommended by the American Association of Physicists in Medicine Task Group 43 report (TG-43) and those generated by the VariSeed version 8.0 TPS for iodine-125 (I-125; Models 6711 and IAI-125A), palladium-103 (Pd-103; Model 200), and cesium-131 (Cs-131; Model Cs-1). Validation was performed for both line source and point source approximations. As part of the treatment planning validation, first a QA phantom (CIRS Brachytherapy QA Phantom Model 045 SN#D7210-3) containing three ellipsoid objects with certified volumes was scanned in order to check the volume accuracy of the contoured structures in MIM Symphony. Then the DICOM data containing 100 patient plans from the VariSeed TPS were imported into the MIM Symphony TPS. The 100 plans included 25 each of I-125 pre-implant plans, Pd-103 pre-implant plans, I-125 Day 30 plans (i.e., from 1 month after implantation), and Pd-103 Day 30 plans. The dosimetric parameters (including prostate volume, prostate D90 values, and rectum V100 values) of the 100 plans were calculated independently on the two TPSs. Other TPS tests that were done included verification of source input and geometrical accuracy, data transfer between different planning systems, text printout, 2D dose plots, DVH printout, and template grid accuracy. According to the line source formalism, the dosimetric results between the MIM Symphony TPS and TG-43 were within 0.5% (0.02 Gy) for r > 1 cm. In the line source approximation validation, MIM Symphony TPS values agreed with VariSeed TPS values to within 0.5% (0.09 Gy) for r > 1 cm. Similarly, in point source approximation validation, the MIM Symphony values agreed to within 1% of the TG-43 and VariSeed values for r > 1 cm. The volume calculations obtained from the MIM Symphony TPS for the CIRS Brachytherapy QA Phantom were within 1% of the actual volume of the phantom. For the clinical cases, the volume and dosimetric parameter calculations for the prostate and rectum did not differ substantially between the pre-implant and Day 30 plans. Overall, our investigations showed negligible differences in dosimetry calculations and planning parameters between the two TPSs. The tests done to check the performance of the MIM Symphony TPS, such as the library data, data transfer, isodose and DVH printout, were found to be satisfactory. On the basis of these results, we conclude that the MIM Symphony TPS can be used as an alternative to the VariSeed TPS for low-dose-rate prostate brachytherapy.

Dataset Information

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

Publications

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

Similar Datasets

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