68Ga-PSMA-11 PET for Prostate Cancer

Recruiting in Palo Alto (17 mi)

Overseen byIvan A. de Kouchovsky, MD

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: University of California, San Francisco

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This phase II trial studies the use of 68Ga-PSMA-11 positron emission tomography (PET) in diagnosing patients with prostate cancer that continues to grow despite the surgical removal of the testes or medical intervention to block androgen production (castration resistant), and has spread to other places in the body (metastatic). 68Ga- PSMA-11 is a new imaging agent that may help get more detailed pictures of the tumor. This trial aims to see whether using 68Ga-PSMA-11 PET scans may help doctors learn more about where disease is located in the body.

Eligibility Criteria

This trial is for men aged 18+ with prostate cancer that has spread and is resistant to castration treatment. They must be starting or already receiving systemic therapy, have a detectable metastatic lesion on a PSMA PET scan, and meet health criteria like sufficient platelet counts. Men unable to give informed consent or follow the study procedures are excluded.

Inclusion Criteria

Sub-cohort A1: Patients must have baseline evaluations performed within 12 weeks prior to the start of systemic therapy.

I had a biopsy after my baseline Ga-PSMA PET scan.

My biopsy target has not received radiation.

See 15 more

Exclusion Criteria

I am unable to give informed consent due to my age or health condition.

Patients with any condition that, in the opinion of the Principal Investigator, would impair the patient's ability to comply with study procedures.

Patients with any contra-indication to magnetic resonance imaging (MRI) (e.g. pacemaker placement, severe claustrophobia) Note: The exclusion criteria above (3) is only applicable for patients scheduled for a Positron Emission Tomography (PET) MRI (PET/MRI).

Treatment Details

Interventions

68Ga-PSMA-11 (Imaging Agent)

Trial OverviewThe trial studies the effectiveness of a new imaging agent called 68Ga-PSMA-11 used in PET scans for better tumor detection in metastatic castration-resistant prostate cancer. It aims to improve disease location identification which could enhance treatment planning.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Experimental (68Ga-PSMA-11 PET)Experimental Treatment2 Interventions

Patients receive gallium 68Ga-PSMA-11 IV and undergo PET at baseline, 16 weeks after initiating therapy, and at time of disease progression.