PET/CT Scan with Tracers for Prostate Cancer

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen byAshesh Jani, MD, MSEE

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Emory University

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?This phase II trial studies how well a positron emission tomography (PET)/computed tomography (CT) scan using fluciclovine F18 compared with a PET/CT scan with 68Ga-PSMA works in planning radiation treatments and enhancing outcomes in patients with prostate adenocarcinoma. Fluciclovine F18 and 68Ga-PSMA are types of tracers, called radiotracers, that are injected and can accumulate in tumor cells to develop images of them during a PET/CT scan. It is not yet known whether giving fluciclovine F18 or 68Ga-PSMA may work better in planning radiation treatments and enhancing outcomes in patients with prostate adenocarcinoma.

Eligibility Criteria

This trial is for men with prostate adenocarcinoma who've had surgery but still have detectable PSA levels, no signs of metastasis outside the pelvis or in bones, and can perform daily activities (ECOG 0-2). They must be willing to undergo pelvic radiotherapy and not have other recent cancers or severe illnesses like heart failure, infections needing IV antibiotics, severe lung disease, AIDS, or conditions that prevent radiation therapy.

Inclusion Criteria

I am able to get out of my bed or chair and move around.

I had surgery to remove my prostate due to adenocarcinoma.

No definitive findings for skeletal metastasis on technetium 99-m methyl diphosphonate (MDP) or F-18 PET bone scan

+3 more

Exclusion Criteria

I do not have severe recent heart issues, infections needing IV antibiotics, severe lung problems, or AIDS.

I cannot have certain PET-CT scans due to my condition.

My cancer has spread to other parts of my body, confirmed by imaging or biopsy.

+2 more

Participant Groups

The study compares two types of PET/CT scans using different tracers—Fluciclovine F18 and Ga68-labeled PSMA—to see which one is better at guiding radiation treatment plans for prostate cancer. The goal is to find out if one tracer leads to improved outcomes over the other in patients post-prostatectomy.

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm I (fluciclovine F18, PET/CT)Experimental Treatment3 Interventions

Patients receive fluciclovine F18 IV and undergo positron emission tomography (PET)/computed tomography (CT) over 30 minutes.

Group II: Arm II (68Ga-PSMA, PET/CT)Active Control3 Interventions

Patients receive gallium Ga68-labeled PSMA-11 IV, wait 60 minutes, then undergo positron emission tomography (PET)/computed tomography (CT) over 30 minutes.