Titre PSMA PET/CT Guided Intensification of Therapy in Patients at Risk of Advanced Prostate Cancer
Protocole ID PATRON
ClinicalTrials.gov ID NCT04557501
Type(s) de cancer Prostate
Phase Phase III
Type étude Clinique
Médicament Radiothérapie
Institution CIUSSS DU CENTRE-OUEST-DE-L'ILE-DE-MONTREAL
   HOPITAL GENERAL JUIF SIR MORTIMER B.DAVIS
      3755 rue de la Côte Ste. Catherine, Montréal, QC, H3T 1E2
Ville Montréal
Investigateur(trice) principal(e) Dr Tamim Niazi
Coordonnateur(trice) Paola Diego
 514-340-8222 poste 27715
Statut Actif en recrutement
Date d'activation 19-09-2023
Critètes d'éligibilité
  • Histological diagnosis of adenocarcinoma of the prostate planned for curative-intent standard-of-care radiotherapy (primary or salvage post prostatectomy) or radical prostatectomy with lymph node dissection.
  • Age ≥ 18
  • High risk of regional or distant metastases as defined by any of:
  • Newly diagnosed and untreated prostate cancer with CAPRA score 6-10, or stage cN1.
  • Prior history of radical prostatectomy and biochemical failure (PSA>0.1ng/mL).
  • Patients must provide study-specific informed consent prior to study entry.
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
Critètes d'exclusion
  • Active or prior androgen deprivation therapy (except 5-alpha reductase inhibitor) terminated < 12 months prior to enrollment.
  • Prior or planned PSMA PET/CT scan outside of this clinical trial.
  • Charlson Comorbidity Index > 5 (see Appendix 2).
  • Prior curative intent treatment for prostate cancer with local therapy other than surgery (primary radiotherapy or ablative therapies)
  • Evidence of extra-pelvic nodal disease (M1a) on conventional imaging (if performed)
  • Evidence of metastatic disease (M1b bone, M1c viscera/soft tissue) on conventional imaging (if performed)