| TITRE |
Intensification du traitement des patients à risque de cancer de la prostate avancé guidée par la TEP/TDM |
| PROTOCOLE ID |
PATRON |
| CLINICAL TRIAL.gov ID |
NCT04557501 |
| TYPE(S) DE CANCER |
Prostate |
| PHASE |
Phase III |
| TYPE D'ÉTUDE |
Clinique |
| INSTITUTION |
CHUM
1051 rue Sanguinet
(514) 890-8000
|
| VILLE |
Montréal
|
| INVESTIGATEUR(RICE) PRINCIPAL(E) |
Cynthia Ménard
|
| COORDONATEUR(RICE) |
Mom Phat
mom.phat.chum@ssss.gouv.qc.ca
514-890-8000 poste 11171
|
| STATUT |
Fermé
|
| CRITÈRES D'ÉLIGIBILITÉ |
(EN)
- 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
|
| CRITÈRES D'EXCLUSION |
(EN)
- 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)
|
