Status:
TERMINATED
18F-DCFPyL Positron Emission Tomography (PET) in Intermediate or High Risk Prostate Cancer
Lead Sponsor:
Ashok Muthukrishnan
Collaborating Sponsors:
Progenics Pharmaceuticals, Inc.
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief 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 increasin...
Detailed Description
This is an trial designed to evaluate the positive predictive value of 18F-DCFPyL PET imaging in men diagnosed with prostate cancer with increasing PSA levels. Patients will receive a single dose of 1...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2022
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT04727736
Start Date
May 1 2021
End Date
December 31 2022
Last Update
February 15 2024
Active Locations (1)
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1
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232