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Prostate Specific Membrane Antigen (PMSA)-Based PET Imaging of High Risk Prostate Cancer

NCT03976843 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 175

Last updated 2026-04-24

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

18F-DCFPyL

18F-labeled agent that is a high affinity small molecule inhibitor of PSMA to detect prostate cancer via PET imaging

Sponsors & Collaborators

  • Lantheus

    collaborator UNKNOWN

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Fatima H Karzai, M.D. · National Cancer Institute (NCI)

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-04
Primary Completion
2027-11-19
Completion
2027-11-19
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03976843 on ClinicalTrials.gov