18F-PSMA-1007 PET/CT Imaging for Prostate Cancer

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: University of Alberta

No Placebo Group

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial uses a special scan to detect prostate cancer cells in adults who have been treated for prostate cancer or are at high risk of it spreading. The scan works by using a radioactive substance that highlights cancer cells, making them visible on the scan.

Research Team

Eligibility Criteria

This trial is for adult men with prostate cancer who've had treatments like radiotherapy or surgery, and now have rising PSA levels or high-risk features. They must be able to consent, lie flat for the scan, and not exceed the PET/CT scanner's weight limit.

Inclusion Criteria

I am an adult who has had prostate cancer treatment and my PSA is rising or doubling quickly.

I am an adult with prostate cancer, high Gleason score, PSA > 20, or T-stage T2c or higher.

I am over 18, had prostate surgery, and my PSA level is above 0.2 µg/L.

Exclusion Criteria

I cannot lie flat for 30 minutes.

Unable to obtain consent

My weight is under 225 kg.

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Treatment Details

Interventions

18F-PSMA-1007 (Diagnostic Test)

Trial OverviewThe study tests a new imaging method using 18F-PSMA-1007 PET/CT scans in patients with recurrent or high-risk prostate cancer. It aims to evaluate safety, how the body processes it, its effectiveness in detecting cancer compared to standard bone and CT scans.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: 18F-PSMA-1007 PET/CT scanExperimental Treatment1 Intervention

Single Arm study - all enrolled patients will undergo an experimental 18F-PSMA-1007 PET/CT scan

18F-PSMA-1007 is already approved in Canada for the following indications: