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Radiopharmaceutical

Gallium Ga 68-labeled PSMA-11 for Prostate Cancer

Phase 2
Waitlist Available
Led By Gregory C Ravizzini
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Pathologically proven prostate cancer
Rising prostate-specific antigen (PSA) after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 36 months
Awards & highlights

Study Summary

This trial looks at using gallium-68 PSMA-11 PET/CT or PET/MRI to find recurrent prostate cancer cells. The radiotracer is injected and can help PET/CT or PET/MRI imaging find the cancer cells.

Eligible Conditions
  • Prostate Cancer

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 36 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Positive predictive value of 68Ga-PSMA-11 (gallium Ga 68-labeled PSMA-11) positron emission tomography (PET)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Diagnostic (gallium Ga 68-labeled PSMA-11, PET/CT, PET/MRI)Experimental Treatment4 Interventions
Patients receive gallium Ga 68-labeled PSMA-11 IV. 50-100 minutes after injection, patients then undergo a PET/CT scan or PET/MRI scan over 60 minutes.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gallium Ga 68-labeled PSMA-11
2019
Completed Phase 2
~1030
Positron Emission Tomography
2008
Completed Phase 2
~2260
Computed Tomography
2017
Completed Phase 2
~2790
Magnetic Resonance Imaging
2017
Completed Phase 3
~1310

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,958 Previous Clinical Trials
1,798,449 Total Patients Enrolled
96 Trials studying Prostate Cancer
29,740 Patients Enrolled for Prostate Cancer
National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,915,646 Total Patients Enrolled
560 Trials studying Prostate Cancer
507,154 Patients Enrolled for Prostate Cancer
Gregory C RavizziniPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
2 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~0 spots leftby Mar 2025