68Ga-PSMA PET/CT Scan for Prostate Cancer

Recruiting in Palo Alto (17 mi)

Overseen ByRajan Rakheja

Age: 18+

Sex: Male

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: University of Saskatchewan

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial involves giving prostate cancer patients a special radioactive substance to take detailed images of their cancer. The goal is to improve how doctors detect and monitor prostate cancer. The substance helps highlight cancer cells, making them easier to see on the scan.

Eligibility Criteria

This trial is for men over 18 with prostate cancer, who can lie still for up to 40 minutes and handle an IV injection. They should be under a doctor's care with an ECOG status of 0-3, meaning they have varying levels of ability to perform daily activities. Those unstable in health, too heavy or large for the PET/CT equipment, or severely claustrophobic cannot join.

Inclusion Criteria

I can care for myself but may not be fully active.

I have been diagnosed with prostate cancer and am under a doctor's care.

I am 18 years old or older.

I can lie still for 40 minutes and handle an IV injection for a PET/CT scan.

I am male.

Exclusion Criteria

I weigh less than 400 lbs and can fit into a PET/CT scanner.

I am not currently experiencing any severe health crises like heart or breathing problems.

Participant Groups

The trial tests how well a special type of imaging called 68Ga-PSMA PET/CT works in detecting prostate cancer spread compared to standard scans. It involves one additional scan using a radioactive tracer and follows patients immediately after and two weeks later for any side effects.

2Treatment groups

Experimental Treatment

Group I: High Risk Prostate CancerExperimental Treatment1 Intervention

Patients with high risk prostate cancer who have not received any definitive treatment. These high-risk patients are defined using the D'Amico Classification System: Those with a PSA of more than 20, or a Gleason score equal to or greater than 8, or have a clinical stage greater than T2c.

Group II: Biochemical ReoccurrenceExperimental Treatment1 Intervention

Patients with biochemical reoccurrence (post-prostatectomy or post radical radiotherapy) or patients with biochemical relapse with rising PSA in spite of taking hormone treatment (this situation is characterized as non-metastatic castration resistant prostate cancer M0CRPC) and compare it to bone scan and CT in 2 groups: PSA \>= 0.2 ng/mL and \<= 0.5 ng/mL or PSA \> 0.5 ng/ml