Detecting Metastases by PyL PET/CT in Subjects Starting Enzalutamide for Untreated Castration Resistant Prostate Cancer.

• Status: Not yet recruiting
• Trial end date: 2023-09-01
• Target enrollment: 0
• Participant gender: Male

Summary

This study aimed to evaluate the diagnostic performance of 18F-DCFPyL (PyL) PET/CT in subjects presenting not previously treated for castration resistant prostate cancer and showing negative or equivocal findings per institutional standard of care conventional imaging

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CHU de Quebec-Universite Laval
• Collaborator: Astellas Pharma Europe Ltd.

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.