PRO-BOOST-N: Prostate-First Versus Combined Prostate and Nodal Dose Escalation in PSMA PET
Patients with prostate cancer and pelvic lymph node involvement (cN1M0) identified on PSMA PET imaging represent a biologically aggressive yet potentially curable disease population. Contemporary management relies on multimodality treatment combining definitive radiotherapy to the prostate and pelvic lymph nodes with l
| Condition(s) | Prostate Cancer, Brachytherapy, Stereotactic Body Radiation Therapy (SBRT), Dose Escalation: Solid Tumors, Regionally Advanced Prostate Cancer |
|---|---|
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Study type | Interventional |
| Summary | Patients with prostate cancer and pelvic lymph node involvement (cN1M0) identified on PSMA PET imaging represent a biologically aggressive yet potentially curable disease population. Contemporary management relies on multimodality treatment combining definitive radiotherapy to the prostate and pelvic lymph nodes with long-term androgen deprivation therapy (ADT), often intensified with androgen receptor pathway inhibitors. Despite these advances, a substantial proportion of patients still develop distant metastatic disease, highlighting the need to optimize local-regional treatment strategies in the era of molecular imaging. The introduction of PSMA PET has fundamentally altered staging accuracy in prostate cancer, enabling earlier and more precise detection of pelvic nodal disease. However |
| Who can participate | 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 org |
| Ages | 18 Years |
| Sex | Male |
| Lead sponsor | Affidea Nu-med Center of Oncological DIagnostics and Therapy |
| Locations | Zamość, Lublin Voivodeship, Poland |
| Start date | 2026-03-19 |
| NCT ID | NCT07426094 |
| Official listing | https://clinicaltrials.gov/study/NCT07426094 |