Condition: Prostate Cancer (Adenocarcinoma) · Prostate Brachytherapy · Stereotactic Body Radiation Therapy (SBRT) · Sponsor: Affidea Nu-med Center of Oncological DIagnostics and Therapy
PRO-BOOST-LC is a prospective, multicenter, randomized phase II/III clinical trial for men with localized or locally advanced prostate cancer without lymph node or distant metastases, confirmed using prostate-specific membrane antigen positron emission tomography/computed tomography (PSMA PET/CT). Radiotherapy is an established curative treatment option for prostate cancer. Several modern radiotherapy strategies can safely deliver high radiation doses to the prostate while limiting dose to surrounding organs. These include stereotactic body radiotherapy (SBRT), high-dose-rate (HDR) brachytherapy, low-dose-rate (LDR) brachytherapy, and combinations of external beam radiotherapy with a prostate boost. However, the optimal dose-escalation strategy for balancing cancer control, treatment-related toxicity, and long-term quality of life remains uncertain in patients staged with modern PSMA PET imaging. The aim of PRO-BOOST-LC is to compare definitive SBRT monotherapy with whole-gland prostate boost strategies delivered after a short course of external beam radiotherapy. Participants will be randomly assigned, according to center capability and patient-level technical suitability, to one of the protocol-defined treatment options. The control group receives SBRT monotherapy. The experimental groups receive external beam radiotherapy followed by one of three whole-gland boost techniques: HDR brachytherapy, LDR brachytherapy, or single-fraction SBRT boost. The primary objective is t…
This description comes directly from the study's public registry record.
Mateusz Edward Bilski, MD, PhD · 048 84 535 99 10 · bilskimat@gmail.com
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| Affidea Nu-Med, Center of Oncological Diagnostics and Therapy | Zamość, Lublin Voivodeship, Poland | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07426055