Prostate-first versus combined prostate and pelvic lymph node radiation dose escalation in PSMA PET–staged node-positive prostate cancer
PRO-BOOST-N: A Randomized Phase II/III Trial Evaluating Prostate-First Versus Combined Prostate and Nodal Dose Escalation in PSMA PET-Staged Node-Positive Prostate Cancer Using an Ultrahypofractionated Whole-Pelvis Radiotherapy Platform
This trial tests whether giving a stronger radiation boost to just the prostate first or to both the prostate and pelvic lymph nodes helps men whose prostate cancer has spread to nearby pelvic lymph nodes seen on PSMA PET.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 1600 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Affidea Nu-med Center of Oncological DIagnostics and Therapy Academic / other |
| Locations | 1 site (Zamość, Lublin Voivodeship) |
| Trial ID | NCT07426094 on ClinicalTrials.gov |
What this trial studies
This randomized phase 2/3 trial enrolls patients with PSMA PET–staged pelvic node‑positive (cN1M0) prostate cancer and combines long‑term androgen deprivation therapy with differing radiotherapy strategies. Participants are assigned to approaches that vary prostate treatment (ultrahypofractionated or SBRT-based prostate radiotherapy with or without an ablative boost) and pelvic nodal dose escalation (intermediate versus higher nodal doses). The study uses modern PSMA PET staging to ensure nodal disease is regional and delivers protocol-defined radiotherapy schedules to compare patterns of failure and disease control. Key outcomes include measures of regional control, distant metastasis‑free survival, and safety/toxicity of the different dose‑escalation strategies.
Who should consider this trial
Good fit: Men aged ≥18 with histologically confirmed prostate adenocarcinoma, PSMA PET or conventional imaging–confirmed pelvic lymph node involvement (cN1) without distant metastases, who are fit for definitive radiotherapy and planned long‑term ADT (ECOG 0–2) are ideal candidates.
Not a fit: Patients with distant metastatic disease (M1), non‑regional nodal or visceral metastases, poor performance status, or those ineligible for definitive radiotherapy or long‑term ADT are unlikely to receive benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could lower the risk of distant metastasis and improve long‑term disease control for men with PSMA PET–detected pelvic node‑positive prostate cancer.
How similar studies have performed: Prior randomized and retrospective studies support combining definitive radiotherapy with long‑term ADT for node‑positive prostate cancer and prostate SBRT/boost techniques have shown promising local control, but optimal pelvic nodal dose escalation in PSMA PET‑staged patients remains largely untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histologically confirmed adenocarcinoma of the prostate. * Prostate cancer with clinically positive pelvic lymph nodes (cN1) without evidence of distant metastatic disease. * Pelvic lymph node involvement limited to regional pelvic lymph nodes (obturator, internal iliac, external iliac, presacral), as assessed by conventional imaging and/or PSMA PET/CT. * No evidence of distant metastatic disease (M0), including absence of non-regional nodal, bone, or visceral metastases. * Candidate for definitive radiotherapy to the prostate and elective pelvic lymph nodes. * Planned treatment with androgen deprivation therapy with or without androgen receptor pathway inhibitors according to protocol. * Eastern Cooperative Oncology Group (ECOG) performance status 0-2. * Adequate organ function allowing delivery of protocol-defined radiotherapy and systemic therapy. * Age ≥18 years. * Ability to understand and willingness to sign a written informed consent. Exclusion Criteria: * Evidence of distant metastatic disease (M1), including non-regional lymph node, bone, or visceral metastases. * Prior definitive local therapy for prostate cancer, including radical prostatectomy, whole-gland radiotherapy, or brachytherapy. * Prior pelvic radiotherapy for any indication that would overlap planned treatment fields. * Prior systemic therapy for prostate cancer other than protocol-allowed neoadjuvant androgen deprivation therapy. * History of castration-resistant prostate cancer. * Concurrent malignancy requiring active treatment, except non-melanoma skin cancer or other malignancies with negligible risk of interference with study outcomes. * Severe uncontrolled comorbidities that would preclude safe delivery of radiotherapy or systemic therapy. * Any condition that, in the opinion of the investigator, would interfere with patient safety or compliance with the study protocol.
Where this trial is running
Zamość, Lublin Voivodeship
- Affidea Nu-Med, Center of Oncological Diagnostics and Therapy — Zamość, Lublin Voivodeship, Poland (Recruiting)
Study contacts
- Principal investigator: Mateusz Bilski, MD, PhD — Affidea Nu-med Center of Oncological DIagnostics and Therapy
- Study coordinator: Mateusz Bilski, MD, PhD
- Email: bilskimat@gmail.com
- Phone: 048 84 535 99 10
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.