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PSMA PET/CT Scan for Prostate Cancer

Phase 3
Waitlist Available
Led By Geoffrey B Johnson
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after imaging scan is complete - up to 1 day
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial offers access to PET/CT scans to detect prostate cancer in patients with metastatic castrate-resistant prostate cancer, using a small amount of radioactive tracer (68Ga-PSMA-11) that binds to the cancer cells.

Who is the study for?
This trial is for adult men with metastatic castrate-resistant prostate cancer who are under care at Mayo Clinic and considered for PSMA-targeted radionuclide therapy. They must not have had a reimbursable 68Ga-PSMA-11 PET scan, be above 18 years old, and able to consent and remain still during imaging.
What is being tested?
The study tests the use of a radioactive tracer in PET/CT scans to detect prostate cancer lesions. It involves using Gallium Ga 68 Gozetotide (68Ga-PSMA-11) which attaches to cancer cells, combined with CT imaging to screen patients before they receive targeted radionuclide therapy.
What are the potential side effects?
Potential side effects may include reactions related to the injection of the radioactive tracer such as mild pain or discomfort at the injection site. The radiation exposure from PET/CT is low but carries a small risk of contributing to future cancer risk.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after imaging scan is complete - up to 1 day
This trial's timeline: 3 weeks for screening, Varies for treatment, and after imaging scan is complete - up to 1 day for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Gallium

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Observational (68Ga-PSMA-11 PET/CT)Experimental Treatment3 Interventions
Patients receive 68Ga-PSMA-11 IV and then undergo a PSMA PET/CT scan throughout the trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Computed Tomography
2017
Completed Phase 2
~2790
Gallium Ga 68 Gozetotide
2021
Completed Phase 3
~1770
Positron Emission Tomography
2011
Completed Phase 2
~2200

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,344 Previous Clinical Trials
3,062,240 Total Patients Enrolled
27 Trials studying Prostate Cancer
6,970 Patients Enrolled for Prostate Cancer
National Cancer Institute (NCI)NIH
13,928 Previous Clinical Trials
41,017,976 Total Patients Enrolled
516 Trials studying Prostate Cancer
332,960 Patients Enrolled for Prostate Cancer
Geoffrey B JohnsonPrincipal InvestigatorMayo Clinic in Rochester

Media Library

Observational (68Ga-PSMA-11 PET/CT) Clinical Trial Eligibility Overview. Trial Name: NCT05547386 — Phase 3
Prostate Cancer Research Study Groups: Observational (68Ga-PSMA-11 PET/CT)
Prostate Cancer Clinical Trial 2023: Observational (68Ga-PSMA-11 PET/CT) Highlights & Side Effects. Trial Name: NCT05547386 — Phase 3
Observational (68Ga-PSMA-11 PET/CT) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05547386 — Phase 3
~47 spots leftby Nov 2025
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