PRO-BOOST-LC: Whole-Gland Boost Strategies Versus SBRT Monotherapy in PSMA-Staged Localized and Locally Advanced Prostate Cancer
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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 to determine whether assignment to a prostate boost strategy improves failure-free survival compared with SBRT monotherapy. Failure-free survival includes biochemical recurrence, local or regional progression, distant metastases, progression-driven salvage treatment, or death from any cause. Key secondary outcomes include metastasis-free survival, overall survival, physician-reported treatment-related toxicity, and patient-reported quality of life, including urinary, bowel, and sexual function. Participants will undergo baseline clinical evaluation, PSA testing, prostate MRI, PSMA PET/CT, and quality-of-life assessments. After treatment, participants will be followed regularly with clinical assessments, PSA testing, toxicity evaluation, patient questionnaires, and imaging when clinically indicated. The study is designed to provide long-term evidence on how best to use modern radiotherapy dose escalation for patients with PSMA-staged localized or locally advanced prostate cancer.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Mężczyzna w wieku co najmniej 18 lat
- •Potwierdzony histologicznie rak gruczołowy prostaty
- •Rak prostaty w stadium początkowym lub zaawansowanym lokalnie bez przerzutów
- •Ujemny wynik w badaniu PET/CT na przerzuty do węzłów chłonnych i odległe
- •Gotowość do leczenia radioterapią z zamiarem wyleczenia
- •Możliwość poddania się planowanemu leczeniu zewnętrznym promieniowaniem i brachoterapią
- •Zgoda na uczestnictwo i podpisanie świadomej zgody
✗ Disqualifies
- •Przerzuty do węzłów chłonnych w miednicy lub odległe przerzuty
- •Wcześniejsze chirurgiczne usunięcie prostaty lub poprzednia radioterapia prostaty
- •Wcześniejsza radioterapia w okolicy miednicy
- •Aktywny nowotwór złośliwy wymagający systemowego leczenia
- •Przeciwwskazania do radioterapii lub znieczulenia
- •Ciężkie choroby towarzyszące uniemożliwiające leczenie
- •Niemożliwość uczestniczenia w badaniu i kontrolach
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- July 21, 2026
- Sex
- Male only
Therapies / drugs in trial
Locations (1)
Affidea Nu-Med, Center of Oncological Diagnostics and Therapy
Zamość, Poland
Trial contact
Mateusz Edward Bilski, MD, PhD
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/22/2026.
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