| TITRE |
(EN) 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 |
| CLINICAL TRIAL.gov ID |
NCT04655365 |
| TYPE(S) DE CANCER |
Prostate |
| PHASE |
Phase II |
| TYPE D'ÉTUDE |
Clinique |
| INSTITUTION |
CENTRE UNIVERSITAIRE DE SANTE MCGILL
1001 boul. Décarie
|
| VILLE |
Montréal
|
| INVESTIGATEUR(RICE) PRINCIPAL(E) |
Armen Aprikian
|
| COORDONATEUR(RICE) |
Rodrigo Skowronski
rodrigo.skowronski@muhc.mcgill.ca
514-934-1934 poste 36275
|
| STATUT |
Actif en recrutement
|
| CRITÈRES D'ÉLIGIBILITÉ |
(EN)
- 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
|
| CRITÈRES D'EXCLUSION |
(EN)
- 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.
|
