18F-DCFPyL Positron Emission Tomography (PET) in Intermediate or High Risk Prostate Cancer

• Status: Recruiting
• Trial end date: 2025-05-01
• Target enrollment: 0
• Participant gender: Male

Summary

This is an interventional, single group assignment, prospective nonrandomized, open label Phase 2 trial designed to evaluate 18F-DCFPyL PET imaging in men diagnosed with prostate cancer with increasing prostate-specific antigen (PSA) levels.

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

Details

• Lead Sponsor: Ashok Muthukrishnan
• Collaborator: Progenics Pharmaceuticals, Inc.

Criteria

Inclusion Criteria:

• Histologically confirmed diagnosis of prostate cancer

• Biochemical recurrence was defined as a PSA of 0.2 or more ng/mL measured more than 6 weeks after prostatectomy or a PSA of 2 or more ng/mL rise above nadir following radiation therapy (ASTRO Phoenix consensus definition)

• Age ≥ 18 years of age

• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%)

• Ability to understand and willingness to sign a written informed consent document

• Willing to comply with clinical trial instructions and requirements

Exclusion Criteria:

• History of another active malignancy within 3 years, other than basal cell and squamous cell carcinoma of the skin

• Presence of prostate brachytherapy implants unless approved by the PI

• Administration of another radioisotope within five physical half-lives of trial enrollment

• Radiation or chemotherapy within 2 weeks prior to trial enrollment

• Estimated glomerular filtration rate (eGFR) < 15 ml/mmol

• Serum total bilirubin > 3 times the upper limit of normal

• Aspartate transaminase (AST) or alanine aminotransferase (ALT) > 5 times the upper limit of normal

• Inadequate venous access

• Claustrophobia or any other condition that would preclude PET imaging

• Patients must not be receiving ADT except per criteria directly below. Patients who received in the past must have a serum testosterone that is recovered to at least 100 ng/dL.

• Patients who have been on ADT +/- novel hormonal agent (NHA) and developed M0 CRPC