Dataset Information

Hemiablative Focal Low Dose Rate Brachytherapy: A Phase II Trial Protocol.

ABSTRACT: 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).

SUBMITTER: Fernandez Ots A

PROVIDER: S-EPMC4923592 | biostudies-literature | 2016 Jun

REPOSITORIES: biostudies-literature

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Hemiablative Focal Low Dose Rate Brachytherapy: A Phase II Trial Protocol.

Fernandez Ots Ana A Bucci Joseph J Chin Yaw Sinn YS Malouf David D Howie Andrew A Enari Komiti Ese KE

JMIR research protocols 20160613 2

<h4>Background</h4>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.<h4>Objective</h4>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 wi ...[more]

PMID: 27296781

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Project description:CivaTech Oncology Inc. (Durham, NC) has developed a novel low-dose rate (LDR) brachytherapy source called the CivaSheet.TM The source is a planar array of discrete elements ("CivaDots") which are directional in nature. The CivaDot geometry and design are considerably different than conventional LDR cylindrically symmetric sources. Thus, a thorough investigation is required to ascertain the dosimetric characteristics of the source. This work investigates the repeatability and reproducibility of a primary source strength standard for the CivaDot and characterizes the CivaDot dose distribution by performing in-phantom measurements and Monte Carlo (MC) simulations. Existing dosimetric formalisms were adapted to accommodate a directional source, and other distinguishing characteristics including the presence of gold shield x-ray fluorescence were addressed in this investigation. Primary air-kerma strength (SK ) measurements of the CivaDots were performed using two free-air chambers namely, the Variable-Aperture Free-Air Chamber (VAFAC) at the University of Wisconsin Medical Radiation Research Center (UWMRRC) and the National Institute of Standards and Technology (NIST) Wide-Angle Free-Air Chamber (WAFAC). An intercomparison of the two free-air chamber measurements was performed along with a comparison of the different assumed CivaDot energy spectra and associated correction factors. Dose distribution measurements of the source were performed in a custom polymethylmethacrylate (PMMA) phantom using GafchromicTM EBT3 film and thermoluminescent dosimeter (TLD) microcubes. Monte Carlo simulations of the source and the measurement setup were performed using MCNP6 radiation transport code. The CivaDot SK was determined using the two free-air chambers for eight sources with an agreement of better than 1.1% for all sources. The NIST measured CivaDot energy spectrum intensity peaks were within 1.8% of the MC-predicted spectrum intensity peaks. The difference in the net source-specific correction factor determined for the CivaDot free-air chamber measurements for the NIST WAFAC and UW VAFAC was 0.7%. The dose-rate constant analog was determined to be 0.555 cGy h-1 U-1 . The average difference observed in the estimated CivaDot dose-rate constant analog using measurements and MCNP6-predicted value (0.558 cGy h-1 U-1 ) was 0.6% ± 2.3% for eight CivaDot sources using EBT3 film, and -2.6% ± 1.7% using TLD microcube measurements. The CivaDot two-dimensional dose-to-water distribution measured in phantom was compared to the corresponding MC predictions at six depths. The observed difference using a pixel-by-pixel subtraction map of the measured and the predicted dose-to-water distribution was generally within 2-3%, with maximum differences up to 5% of the dose prescribed at the depth of 1 cm. Primary SK measurements of the CivaDot demonstrated good repeatability and reproducibility of the free-air chamber measurements. Measurements of the CivaDot dose distribution using the EBT3 film stack phantom and its subsequent comparison to Monte Carlo-predicted dose distributions were encouraging, given the overall uncertainties. This work will aid in the eventual realization of a clinically viable dosimetric framework for the CivaSheet based on the CivaDot dose distribution.

Project description:To compare the outcomes of localized prostate cancer treatment with high-dose-rate brachytherapy (HDR-BT) and low-dose-rate brachytherapy (LDR-BT), we examined 924 patients treated with HDR-BT + external beam radiotherapy (EBRT) and 500 patients treated with LDR-BT ± EBRT using multi-institutional retrospective data. The HDR-BT treated advanced disease with more hormonal therapy than LDR-BT. To reduce background selection bias, we performed inverse probability of treatment weighting (IPTW) analysis using propensity scores and excluded patients with T3b-4 disease/ initial prostate-specific antigen (PSA) levels > 50 ng/ml. The actuarial 5-year biochemical control rates (5y-bNED) were 96.3% and 95.7% in the HDR-BT and LDR-BT groups, respectively. The corresponding values were 100% and 96.5% in the low-risk group; 97.4% and 97.1% in the intermediate-risk group (97.2% and 97% in the higher titer group and 97.5% and 94.6% in the lower titer group, respectively); and 95.7% and 94.9% in the selected high-risk group, respectively. IPTW correction indicated no significant difference among the groups. The 5y-bNED in the HDR-BT + EBRT, LDR-BT + EBRT, and LDR-BT alone groups were 96.3%, 95.5%, and 97%, respectively (P = 0.3011). The corresponding values were 97.4%, 94.7%, and 96.6% (P = 0.1004) in the intermediate-risk group (97.5%, 100%, and 94.5% in the lower titer group [P = 0.122] and 97.2%, 96.2%, and 100% [P = 0.664] in the higher titer group, respectively) and 95.7%, 95.5%, and 100% (P = 0.859) in the high-risk group, respectively. The HDR-BT group showed a lower incidence of acute grade ≥ 2 genitourinary toxicities; the incidence of other early and late grade ≥ 2 toxicities were similar between the HDR-BT and LDR-BT groups. Acute genitourinary toxicity predicted the occurrence of late genitourinary toxicity. EBRT increased the risk of grade ≥ 2 gastrointestinal toxicity. HDR-BT + EBRT is a good alternative to LDR-BT ± EBRT for low-, intermediate-, and selected high-risk patients.

Dataset Information

Hemiablative Focal Low Dose Rate Brachytherapy: A Phase II Trial Protocol.

Publications

Hemiablative Focal Low Dose Rate Brachytherapy: A Phase II Trial Protocol.

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