RecruitingPhase 2/3

PRO-BOOST-LC: Whole-Gland Boost Strategies Versus SBRT Monotherapy in PSMA-Staged Localized and Locally Advanced Prostate Cancer

Poland1,000 participantsStarted 2026-03-19

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Male patients aged ≥18 years. * Histologically confirmed adenocarcinoma of the prostate. * Localized or locally advanced prostate cancer classified as cT1-4, cN0, cM0. * Negative pelvic nodal and distant metastatic disease on baseline PSMA PET. * NCCN favourbale or unfavourbale intermediate-, high-, or very high-risk disease. * Candidate for definitive radiotherapy with curative intent. * ECOG performance status 0-2. * Baseline PSA available prior to randomization. * Ability to undergo external beam radiotherapy and brachytherapy or SBRT according to protocol. * Planned androgen deprivation therapy (ADT) permitted according to protocol-defined risk group. * Ability to understand and willingness to sign written informed consent. Exclusion Criteria: * Evidence of pelvic nodal (cN1) or distant metastatic disease (cM1) on baseline imaging. * Prior definitive local treatment for prostate cancer, including prostatectomy, brachytherapy, or definitive external beam radiotherapy. * Prior pelvic radiotherapy for any malignancy. * Prior systemic therapy for prostate cancer other than protocol-allowed neoadjuvant ADT. * History of other active malignancy requiring systemic treatment (except adequately treated non-melanoma skin cancer). * Contraindications to radiotherapy or anesthesia required for brachytherapy procedures. * Severe uncontrolled comorbidities that would preclude protocol treatment. * Inability to comply with study procedures or follow-up schedule.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Failure-Free Survival (FFS)

Timeframe: From randomization up to 10 years

Metastasis-Free Survival (MFS) hierarchical

Timeframe: From randomization up to 10 years

Trial details

NCT IDNCT07426055

SponsorAffidea Nu-med Center of Oncological DIagnostics and Therapy

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2033-12

Contact for this trial

Mateusz Edward Bilski, MD, PhD

048 84 535 99 10 bilskimat@gmail.com

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