Ga-68 PSMA PET/CT for Prostate Cancer

Age: 18+

Sex: Male

Trial Phase: Phase 2 & 3

Sponsor: Michael Graham PhD, MD

Must not be taking: Furosemide, Sulfa drugs

Disqualifiers: Stevens-Johnson syndrome, Paget's disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

6 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This study investigates if a new drug (PSMA) makes prostate cancer easier to identify in positron-emission tomography (PET) imaging. If this works, prostate cancer treatments can be prescribed that match the location of the disease. PSMA is radiolabeled with Gallium-68 (Ga-68). This means a participant receives a small dose of radiation from the drug - less than the annual radiation limit for a medical worker. To test this new drug, participants will receive an injection of Ga-68 PSMA and then have a PET scan. This PET scan, and the reported results, will be entered into the medical record and shared with the treating oncologists.

Who Is on the Research Team?

Michael M Graham, Ph.D., MD

Principal Investigator

University of Iowa

Are You a Good Fit for This Trial?

This trial is for men with prostate cancer that has returned after surgery or radiation therapy. They must have a specific level of PSA, a protein linked to prostate cancer, in their blood and be generally healthy without other recent cancers (except certain skin or superficial bladder cancers). Participants can't join if they're taking experimental drugs, allergic to sulfa medications, have heart problems, uncontrolled illnesses, or conditions affecting study compliance.

Inclusion Criteria

You are not taking any experimental drugs that have not been approved by regulatory agencies for testing their effectiveness.

I can understand and agree to participate in the study.

My PSA levels are increasing after having surgery or radiation for prostate cancer.

Exclusion Criteria

You are allergic to medications that contain sulfa.

I have no other cancer besides the one currently being studied.

You have had Stevens-Johnson syndrome in the past.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants receive an injection of Ga-68 PSMA and undergo a PET scan to identify prostate cancer

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness of the imaging results, with clinical follow-up and additional imaging as needed

12 months

Optional Second Imaging

Participants may be invited for a second 68Ga PSMA scan if initial results show positive lymph nodes or metastases

What Are the Treatments Tested in This Trial?

Interventions

• Ga-68 PSMA-HBED-CC PET

Trial Overview The trial tests whether injecting Ga-68 PSMA before PET/CT imaging helps better detect where the prostate cancer is located. This could lead to more targeted treatments. The drug contains a small amount of radioactive material but within safe exposure limits for patients.

How Is the Trial Designed?

Group I: 68Ga PSMA PET scan Experimental Treatment 1 Intervention

Ga-68 PSMA-HBED-CC PET/CT scan

Who Is Running the Clinical Trial?

Michael Graham PhD, MD

Lead Sponsor

Trials

3

Recruited

290+