| 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 |
CENTRE HOSPITALIER DE L'UNIVERSITE DE MONTREAL
|
| Ville |
Montréal |
| Investigateur(trice) principal(e) |
Dre Cynthia Ménard
|
| Coordonnateur(trice) |
Mom Phat
514-890-8000 poste 11171
|
| Statut |
 Actif en recrutement |
| 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)
|
Groupe d'étude en oncologie du Québec