PRO-BOOST-N: Prostate-First Versus Combined Prostate and Nodal Dose Escalation in PSMA PET-Staged Node-Positive Prostate Cancer

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 ly

Trial Details

NCT ID
NCT07426094
Phase
PHASE2 / PHASE3
Sponsor
Affidea Nu-med Center of Oncological DIagnostics and Therapy
Status
RECRUITING
Cancer Type
Prostate Cancer
Interventions
  • Ultrahypofractionated Whole-Pelvis Radiotherapy
  • SBRT-Based Prostate Radiotherapy (No Boost)
  • Ablative Prostate Boost
  • Intermediate Nodal Dose Escalation
  • Higher Nodal Dose Escalation
  • Androgen Deprivation Therapy (ADT)
Locations (sample)
  • Zamość, Lublin Voivodeship, Poland|50.72314,23.25196

Key Eligibility 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 convent…
  • No evidence of distant metastatic disease (M0), including absence of non-regional nodal, bone, or visceral metastases.

For full eligibility, visit ClinicalTrials.gov.

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