Status:
ACTIVE_NOT_RECRUITING
18F-DCFPyL Positron Emission Tomography (PET)/Computed Tomography (CT) in Men With Prostate Cancer
Lead Sponsor:
Columbia University
Conditions:
Prostatic Neoplasms
Eligibility:
MALE
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
PyL, also known as \[18F\]DCFPyL, is a second-generation fluorinated prostate-specific membrane antigen (PSMA) targeted PET imaging agent. In preliminary studies it demonstrates a higher detection of ...
Detailed Description
The investigators will conduct a prospective phase II/III study of 300 men diagnosed with prostate cancer with a rising prostate-specific antigen (PSA). Upon enrollment, subjects will undergo standard...
Eligibility Criteria
Inclusion
- Histologically confirmed diagnosis of prostate cancer
- PSA ≥ 0.2ng/ml
- 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
- Wiling to comply with clinical trial instructions and requirements
- Willing to cover the cost of PyL PET/CT imaging if funds are not available
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
- Serum creatinine \> 3 times the upper limit of normal
- 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
Key Trial Info
Start Date :
February 12 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2023
Estimated Enrollment :
129 Patients enrolled
Trial Details
Trial ID
NCT03824275
Start Date
February 12 2019
End Date
December 1 2023
Last Update
May 11 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Columbia University Irving Medical Center
New York, New York, United States, 10032