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68Ga-PSMA-11 PET for Prostate Cancer

Phase 2
Waitlist Available
Led By Rahul R Aggarwal, MD
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
- No history of radiation therapy to the target metastatic lesion selected for tumor biopsy.
Patient must be Aged 18 years or older at the time of study entry.
Must not have
Patients who because of age, general medical or psychiatric condition, or physiologic status cannot give valid informed consent.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights
No Placebo-Only Group

Summary

This trial uses 68Ga-PSMA-11 PET scans to find out if it can help doctors learn more about where disease is located in the body for patients with prostate cancer who have had their testes removed or have been castrated.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While not explicitly listed, potential side effects may include reactions at the injection site of the imaging agent, discomfort from lying still during PET scanning, and risks associated with biopsies if performed (e.g., bleeding or infection).

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My biopsy target has not received radiation.
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I am 18 years old or older.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My prostate cancer is getting worse despite hormone therapy.
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I don't have any conditions that would make a biopsy unsafe.
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My scan shows at least one cancer spread with specific protein uptake.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am unable to give informed consent due to my age or health condition.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Mean Maximum Standard Uptake Value (SUVmax)
Median SUVmax
Percentage of Participants Who Progressed by Prostate-specific Antigen (PSA) Response Group
Secondary study objectives
Comparison Between Mean Percent Change in SUVmax With Objective Response Group
Comparison of Change in SUVmax-ave Group on Overall Survival (OS)
Comparison of Change in SUVmax-ave Group on Progression Free Survival (PFS)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
68Ga-PSMA-11
2019
Completed Phase 3
~270
Positron Emission Tomography (PET)
2018
Completed Phase 4
~1540

Find a Location

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor
2,593 Previous Clinical Trials
14,887,935 Total Patients Enrolled
52 Trials studying Prostate Cancer
17,597 Patients Enrolled for Prostate Cancer
Thomas HopeLead Sponsor
10 Previous Clinical Trials
1,807 Total Patients Enrolled
3 Trials studying Prostate Cancer
1,056 Patients Enrolled for Prostate Cancer
Conquer Cancer FoundationOTHER
19 Previous Clinical Trials
3,910 Total Patients Enrolled
1 Trials studying Prostate Cancer
51 Patients Enrolled for Prostate Cancer
Gateway for Cancer ResearchOTHER
46 Previous Clinical Trials
2,490 Total Patients Enrolled
Prostate Cancer FoundationOTHER
49 Previous Clinical Trials
2,945 Total Patients Enrolled
28 Trials studying Prostate Cancer
1,960 Patients Enrolled for Prostate Cancer
Rahul R Aggarwal, MDPrincipal InvestigatorUniversity of California, San Francisco
2 Previous Clinical Trials
114 Total Patients Enrolled
1 Trials studying Prostate Cancer
60 Patients Enrolled for Prostate Cancer
Ivan A de Kouchovsky, MDPrincipal InvestigatorUniversity of California, San Francisco

Media Library

68Ga-PSMA-11 Clinical Trial Eligibility Overview. Trial Name: NCT04716725 — Phase 2
Prostate Cancer Research Study Groups: Experimental (68Ga-PSMA-11 PET)
Prostate Cancer Clinical Trial 2023: 68Ga-PSMA-11 Highlights & Side Effects. Trial Name: NCT04716725 — Phase 2
68Ga-PSMA-11 2023 Treatment Timeline for Medical Study. Trial Name: NCT04716725 — Phase 2
~4 spots leftby Dec 2025
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