68Ga-PSMA-11 PET for Prostate Cancer

Overseen By UCSF Genitourinary Medical Oncology Recruitment

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: University of California, San Francisco

Disqualifiers: Inability to consent, MRI contraindications, 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: 11

15 Participants Needed

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.

Research Team

Ivan A. de Kouchovsky, MD

Principal Investigator

University of California, San Francisco

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.

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).

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Imaging

Participants receive gallium Ga 68-PSMA-11 intravenously and undergo PET imaging

1 day

1 visit (in-person)

Follow-up Imaging

Participants undergo PET imaging 16 weeks after initiating therapy to assess changes in SUVmax

16 weeks

1 visit (in-person)

Disease Progression Imaging

Participants undergo PET imaging at the time of disease progression

Variable

1 visit (in-person)

Long-term Follow-up

Participants are followed up every 3 months for up to 24 months to monitor overall survival and progression-free survival

24 months

8 visits (in-person)

Treatment Details

Interventions

• 68Ga-PSMA-11

Trial Overview The 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

Group I: Experimental (68Ga-PSMA-11 PET) Experimental Treatment 2 Interventions

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

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Thomas Hope

Lead Sponsor

Trials

11

Recruited

1,800+

Conquer Cancer Foundation

Collaborator

Trials

22

Recruited

4,000+

Gateway for Cancer Research

Collaborator

Trials

47

Recruited

2,500+

Prostate Cancer Foundation

Collaborator

Trials

52

Recruited

3,000+