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 UNIVERSITAIRE DE SANTE MCGILL
SITE GLEN
1001 boul. Décarie , Montréal, QC, H4A 3J1
|
Ville |
Montréal |
Investigateur(trice) principal(e) |
Dr Fabio Cury
|
Coordonnateur(trice) |
Rodrigo Skowronski
514-934-1934 poste 36275
|
Statut |
Actif en recrutement |
Date d'activation |
18-10-2022 |
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)
|