NCT03976843Active, not recruitingPhase 2
Prostate Specific Membrane Antigen (PMSA)-Based PET Imaging of High Risk Prostate Cancer
A Phase II Multi-Institutional Trial to Evaluate Prostate Specific Membrane Antigen (PMSA)-Based PET Imaging of High Risk Prostate Cancer
Source: ClinicalTrials.gov · Last updated 8 Sept 2026
Brief summary (registry, in English)
Background: People with prostate cancer usually have their cancer imaged with a CT scan and bone scan. They then have their prostate gland removed. Researchers want to test a scan that might predict if prostate cancer will return after this surgery. Objective: To test if a PET/CT scan before the prostate gland is removed can predict if prostate cancer will return. Also, to test if this approach is better or worse than the usual approach for prostate cancer. Eligibility: Men ages 18 and older with prostate cancer that appears to be contained within the prostate but is at risk of having spread Design: Participants will be screened with: * Medical history * Blood tests * CT and MRI scans: Participants will lie in a machine. The machine will take pictures of the body. * Bone scan Participants will have a radiotracer injected into a vein. They will have a PET/CT scan of their whole body 60-90 minutes later. During the scan, they will lie on their back and stay still. Within 60 days after the scan, participants will have surgery. This will remove the prostate gland and lymph nodes around it. Some tissue will be used for genetic testing. If the PET/CT scan suggests the cancer has spread, participants may need to have another biopsy within 60 days after the scan. After surgery, participants will have follow-up visits for 5 years. They will have 5 visits the first year and 2 the second. Then they will have visits once a year. If participants cancer returns, they will have repeat PET/CT scans.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 175 (actual)
- First submitted
- 5 Jun 2019
- Start date
- 4 Dec 2019
- Primary completion date
- 19 Nov 2027
- Lead sponsor
- National Cancer Institute (NCI)
- Diseases
- Prostate cancer
- NCT number
- NCT03976843
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 175
- From 4 Dec 2019 to the primary completion date, 19 Nov 2027
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any investigational agents in the past 28 days prior to enrollment.
- Any prior hormone therapy used to treat prostate cancer, except limited androgen receptor antagonist therapy, defined as less than or equal to 3 days of treatment. The medication must be discontinued within 5 half-lives of the compound prior to study entry.
- Any prior therapy for prostate cancer with surgery, radiation, and/or chemotherapy.
- Contraindication to MRI or PET:
- Patients weighing more than weight limit for the scanner tables or unable to fit within the imaging gantry
- Prior reaction to 18F-DCFPyL
- Patients with pacemakers, cerebral aneurysm clips, shrapnel injury or implantable electronic device that are not MRI compatible at 3 T
- Severe claustrophobia unresponsive to oral anxiolytics
- Radiotracer administered within 5 half-lives prior to the date of 18F-DCFPyL PET/CT imaging.
- PSMA-targeted imaging within 6 months with 18F-DCFPyL tracer prior to the date of 18F-DCFPyL PET/CT imaging. Participants can have PSMA targeted imaging with Gallium.
Other illness
- Distant metastatic disease on conventional imaging studies (computed tomography (CT)) of the abdomen and pelvis and bone scan. NaF PET/CT scan cannot substitute for a bone scan. Given lack of specificity of CT for lymph node metastases at lower thresholds, pelvic lymph nodes below 2 cm in the short axis are allowed.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Other medical conditions deemed by the principal investigator (or associates) to make the subject unsafe/ineligible for the protocol procedures or for radical prostatectomy.
- A malignancy within the past 3 years for which prostatectomy is a contraindication.
Other
- Clinical stage T4 (tumor invades adjacent structures except seminal vesicles).
- Unable to refrain from fathering a child or donating sperm for 10 days after each 18F-DCFPyL injection.
Criteria the registry did not label
- INCLUSION CRITERIA:
- Patients must have histologically proven prostate adenocarcinoma confirmed by a CLIA certified laboratory.
- Must have prostate cancer with high risk features defined as:
- Gleason 8 and higher OR
- PSA \> 20 ng/mL OR
- Clinical stage T3a (i.e. likely extraprostatic extension on MRI) or T3b
- Patients must be eligible for and must be planning to undergo radical prostatectomy and lymphadenectomy regardless of findings on 18F-DCFPyL PET/CT
- Men age greater than or equal to 18 years.
- ECOG performance status \<2
- Patients must have adequate organ and marrow function as defined below:
- Hemoglobin greater than or equal to 9 g/dL
- leukocytes greater than or equal to 3,000/mcL
- platelets greater than or equal to 100,000/mcL
- total bilirubin \<2 X normal institutional limits
- AST(SGOT)/ALT(SGPT) less than or equal to 3 X normal institutional limits
- creatinine \<2 X normal institutional limits
- OR
- eGFR greater than or equal to 50 mL/min/1.73 m\^2 for patients with creatinine levels above institutional normal. (calculated via the MDRD equation)
- Ability of subject to understand and the willingness to sign a written informed consent document.
- Willingness and ability to undergo biopsy of radiotracer-avid lesion if feasible.
- Willingness and ability to undergo multiparametric prostate MRI and 18F-DCFPyL PET/CT
Age in the registry: 18 years to 99 years · Sex: Male · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Johns Hopkins University Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| National Institutes of Health Clinical Center Coordinator of this site? Confirm its status | Bethesda | United States | Unknown status |
| Brigham and Women's Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Tulane University Coordinator of this site? Confirm its status | New Orleans | United States | Unknown status |
| Memorial Sloan-Kettering Cancer Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Thomas Jefferson University Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.