PRO-BOOST-N: Prostate-First Versus Combined Prostate and Nodal Dose Escalation in PSMA PET-Staged Node-Positive 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-N is a prospective, multicenter, randomized phase II/III clinical trial for patients with prostate cancer and pelvic lymph node involvement (cN1M0) confirmed by PSMA PET/CT, without distant metastatic disease. Patients with PSMA PET-staged node-positive prostate cancer are potentially curable, but remain at substantial risk of distant progression despite contemporary treatment with radiotherapy, long-term androgen deprivation therapy, and, when appropriate, androgen receptor pathway inhibitors. The optimal way to intensify radiotherapy to the prostate and PSMA PET-positive pelvic lymph nodes remains uncertain in the era of modern molecular imaging. All participants receive a standardized ultrahypofractionated whole-pelvis radiotherapy backbone delivered in five fractions, combined with long-term systemic therapy according to contemporary clinical practice. The study uses a 2 x 2 factorial randomized design to evaluate two treatment questions. The primary comparison evaluates whether prostate dose escalation improves metastasis-free survival compared with no additional prostate boost. Patients assigned to prostate boost receive one of three protocol-defined boost techniques: high-dose-rate brachytherapy, low-dose-rate brachytherapy, or single-fraction SBRT. If more than one prostate boost technique is available at the treating center and technically suitable for the patient, the boost technique is assigned by embedded subrandomization. The key secondary, hierarchically tested comparison evaluates nodal dose escalation by comparing two predefined dose levels to PSMA PET-positive pelvic lymph nodes. Organ-at-risk-driven nodal dose de-escalation is permitted within the higher-dose arm when required for patient safety and protocol compliance. The primary endpoint is metastasis-free survival (MFS) . Secondary endpoints include overall survival (OS), radiographic progression-free survival (rPFS), intraprostatic and regional nodal control, time to castration-resistant prostate cancer, time to next systemic therapy, treatment-related adverse events graded according to CTCAE version 6.0, and patient-reported quality of life, including urinary, bowel, sexual, and global health domains. PRO-BOOST-N aims to determine the optimal radiotherapy intensification strategy for patients with PSMA PET-staged node-positive prostate cancer by prospectively evaluating prostate-directed and nodal-directed dose escalation within a modern, standardized radiotherapy platform.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Potwierdzony histologicznie rak gruczołu krokowego
- •Rak prostaty z przerzutami do węzłów chłonnych w miednicy, bez przerzutów na odległość
- •Przerzuty ograniczone do węzłów w miednicy (w okolicy kości krzyżowej, tętnicy biodrowej)
- •Brak przerzutów do kości, innych narządów lub węzłów chłonnych poza miedznicą
- •Możliwość otrzymania radioterapii prostaty i węzłów chłonnych
- •Wiek co najmniej 18 lat
- •Zdolność do zrozumienia badania i podpisania zgody
- •Dobry stan ogólny pozwalający na leczenie (skala ECOG 0-2)
✗ Disqualifies
- •Przerzuty na odległość (do kości, innych narządów, węzłów poza miedznicą)
- •Wcześniejsze operacyjne usunięcie prostaty lub radioterapia prostaty
- •Wcześniejsza radioterapia miednicy, która mogłaby kolidować z planem leczenia
- •Wcześniejsze leczenie systemowe raka prostaty (poza przygotowawczą terapią hormonalną)
- •Historia raka opornego na terapię hormonalną
- •Inny nowotwór wymagający aktywnego leczenia (z wyjątkiem czerniaków skóry)
- •Poważne choroby towarzyszące uniemożliwiające bezpieczne przeprowadzenie leczenia
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 Bilski, MD, PhD
Mateusz 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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