PSMA-Based PET Imaging for Prostate Cancer

Recruiting at6 trial locations

Overseen by Fatima H Karzai, M.D.

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Research Team

Fatima H Karzai, M.D.

Principal Investigator

National Cancer Institute (NCI)

Eligibility Criteria

Men over 18 with high-risk prostate cancer that's likely still in the prostate but could have spread. They must be healthy enough for surgery, able to undergo certain scans and biopsies if needed, and not have had any prior treatments or other cancers within 3 years.

Inclusion Criteria

I am a man aged 18 or older.

I am planning to have surgery to remove my prostate and lymph nodes.

Ability of subject to understand and the willingness to sign a written informed consent document.

Exclusion Criteria

I have had treatment for prostate cancer, including surgery, radiation, 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, 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, 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, Unable to refrain from fathering a child or donating sperm for 10 days after each 18FDCFPyL injection.

I have had hormone therapy for prostate cancer, but only short-term androgen blocker use.

Treatment Details

Interventions

• 18F-DCFPyL (Radiopharmaceutical)

Trial Overview The trial is testing a new PET/CT scan using the tracer 18F-DCFPyL before removing the prostate gland to see if it can predict cancer recurrence better than current methods. Participants will be followed up for five years after surgery.

Participant Groups

Group I: 1/18F-DCFPyL PET/CT + radical prostatectomy Experimental Treatment 1 Intervention

18F-DCFPyL PET/CT with radical prostatectomy and lymphadenectomy

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School

Lantheus

Collaborator

Trials

1

Recruited

180+