| Titre |
Detection and Monitoring of Metastasis by 18F-DCFPyL PET/CT in Subjects Starting Enzalutamide for Untreated Castration Resistant Prostate Cancer and Negative Conventional Imaging |
| Protocole ID |
PROSTEP-002 |
| ClinicalTrials.gov ID |
NCT04655365 |
| Type(s) de cancer |
Prostate |
| Phase |
Phase II |
| Stade |
Résistant à la castration - métastatique |
| Type étude |
Clinique |
| Institution |
CHU DE QUEBEC – UNIVERSITE LAVAL
 L'HOTEL-DIEU DE QUEBEC ET CRCEO
11 Côte du Palais, Québec, QC, G1R 2J6
|
| Ville |
Québec |
| Investigateur(trice) principal(e) |
Dr Frédéric Pouliot
|
| Coordonnateur(trice) |
Marilyn Savard
418-525-4444 poste 20414
|
| Statut |
 Actif en recrutement |
| Critètes d'éligibilité |
- Histologically confirmed adenocarcinoma of the prostate per original diagnosis, with undergoing androgen deprivation therapy such as prior bilateral orchiectomy or surgical castration or LHRH-agonists/LHRH-antagonists.
- Suspected recurrence of prostate cancer based on rising PSA under androgen deprivation therapy. Recurrent castration resistant prostate cancer patients is defined by a rising PSA >1 ng/mL under ADT or surgical castration and with testosterone castration levels < 1.7 nM (PCWG3 criteria).
- Negative or equivocal findings for prostate cancer on conventional imaging bone scan AND 2) abdomen-pelvis CT/MRI and chest CT or FDG-PET/CT) performed as standard of care workup within 42 days of Day 1(accrual).
- The subject is candidate for second line androgen axis targeted inhibitors such as enzalutamide and planned to receive it.
- Life expectancy ≥6 months as determined by the investigator
- Able and willing to provide signed informed consent and comply with protocol requirement
- PSA doubling time less or equal to 10 months
|
| Critètes d'exclusion |
- Subjects administered any high energy (>300 KeV) gamma-emitting radioisotope within 5 physical half-lives prior to study drug injection.
- Receipt of investigational drug therapy for prostate cancer within 60 days of Day 1.
- Subjects with any medical condition or other circumstances that, in the opinion of the investigator, compromise obtaining reliable data, achieving study objectives, or completing the study.
- Contraindication to enzalutamide
- Treatment with 5-α reductase inhibitors (finasteride, dutasteride) within 4 weeks of randomization.
|
Groupe d'étude en oncologie du Québec