NCT07426055
PRO-BOOST-LC: Whole-Gland Boost Strategies Versus SBRT Monotherapy in PSMA-Staged Localized and Locally Advanced Prostate Cancer
Recruiting · Phase 2, Phase 3 · Affidea Nu-med Center of Oncological DIagnostics and Therapy · registry updated 2026-07-21
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
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....
Inclusion
- 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.
Exclusion
- 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.