- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04727736
18F-DCFPyL Positron Emission Tomography (PET) in Intermediate or High Risk Prostate Cancer
January 23, 2024 updated by: Ashok Muthukrishnan
Phase 2 Study of 18F-DCFPyL Positron Emission Tomography (PET) in Men With Intermediate or High Risk Biochemically Recurrent Prostate Cancer
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.
Study Overview
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 18FDCFPyL PET and undergo a PET imaging study.
18F-DCFPyL Injection is an 18F-labeled small molecule that targets the extracellular domain of PSMA.
One intravenous catheter will be placed for radiopharmaceutical administration.
Patients will be injected with ≤ 333 MBq (≤ 9 mCi) of 18F-DCFPyL via this catheter.
The dose range for 18F-DCFPyL will be 7 - 9 mCi.
The PET imaging may be repeated at a later date if the biopsy of the lesion is negative and if the lesion is present on follow-up imaging.
Study Type
Interventional
Enrollment (Actual)
47
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15232
- UPMC Hillman Cancer Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 18F-DCFPyL + PET imaging
Participants will receive a single dose of 18F-DCFPyL and undergo a PET imaging study. (The PET imaging may be repeated at a later date if the biopsy of the lesion is negative and if the lesion is present on follow-up imaging.) |
18F-DCFPyL (single dose injection) - a radiolabeled prostate-specific membrane antigen (PSMA) ligand
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Positive Predictive Value (PPV) (Per-patient)
Time Frame: Up to 12 months
|
Number of patients with true positive scans (TP - positive test with disease) divided by number of TP plus number of false positive scans (FP - positive test without disease).
A scan will be deemed 'positive' if at least one lesion suggestive of disease recurrence is noted.
Prostate lesions and lymph nodes will be considered positive if the uptake in those lesions exceeds blood pool activity.
Bone lesions will be recorded as positive if the activity is higher than normal bone marrow uptake.
|
Up to 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Positive Predictive Value (PPV) (Per-region)
Time Frame: Up to 12 months
|
Number of true positive scans (TP - positive test with disease) divided by number of TP plus number of false positive scans (FP - positive test without true disease), by region (prostate bed, locoregional lymph nodes, distant lymph nodes, bones, and/or visceral organs).
A scan will be deemed 'positive' if at least one lesion suggestive of disease recurrence is noted.
Prostate lesions and lymph nodes will be considered positive if the uptake in those lesions exceeds blood pool activity.
Bone lesions will be recorded as positive if the activity is higher than normal bone marrow uptake.
|
Up to 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Ashok Muthukrishnan, MD, MS, University of Pittsburgh - Associate Professor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2021
Primary Completion (Actual)
December 31, 2022
Study Completion (Actual)
December 31, 2022
Study Registration Dates
First Submitted
January 22, 2021
First Submitted That Met QC Criteria
January 22, 2021
First Posted (Actual)
January 27, 2021
Study Record Updates
Last Update Posted (Actual)
February 15, 2024
Last Update Submitted That Met QC Criteria
January 23, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HCC 20-009
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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