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 CIUSSS DE L'ESTRIE – CENTRE HOSP. UNIV. DE SHERBROOKE
   HOPITAL FLEURIMONT
      3001 12e Avenue Nord, Sherbrooke, QC, J1H 5N4
Ville Sherbrooke
Investigateur(trice) principal(e) Dr Robert Sabbagh
Coordonnateur(trice) Elsie Morneau
 819-346-1110 poste 12827
Statut Actif en recrutement
Date d'activation 04-10-2023
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.