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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Comparison between mean percent change in SUVmax with Prostate-specific antigen (PSA) response group
Mean maximum standard uptake value (SUVmax)
Median SUVmax
Secondary outcome measures
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)

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
~170
Positron Emission Tomography (PET)
2018
Completed Phase 4
~1390

Find a Location

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor
2,505 Previous Clinical Trials
15,237,540 Total Patients Enrolled
52 Trials studying Prostate Cancer
17,033 Patients Enrolled for Prostate Cancer
Thomas HopeLead Sponsor
9 Previous Clinical Trials
1,593 Total Patients Enrolled
3 Trials studying Prostate Cancer
1,056 Patients Enrolled for Prostate Cancer
Conquer Cancer FoundationOTHER
19 Previous Clinical Trials
3,960 Total Patients Enrolled
1 Trials studying Prostate Cancer
51 Patients Enrolled for Prostate Cancer

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the ultimate goal of this clinical experiment?

"This clinical trial is designed to assess the Mean maximum standard uptake value (SUVmax) over a Baseline, and up to 16 weeks after initiation of therapy period. Secondary outcomes include comparing Change in SUVmax-ave Group on Overall Survival (OS), mean percent change in SUVmax with objective response group, and comparison between mean percent change in maximum standard uptake value (SUVmax) with objective response group. These analyses will be conducted using log-rank test and Mann-Whitney test techniques."

Answered by AI

What therapeutic benefits does 68Ga-PSMA-11 bring to patients?

"68Ga-PSMA-11 is frequently employed for the management of tumor antigens and other ailments such as presumed metastasis, positron emission tomography imaging, and prostate cancer."

Answered by AI

What is the current size of this experiment's participant pool?

"Affirmative. Clinicaltrials.gov's data reveals that this study, initially published on September 28th 2021 is actively recruiting patients. 110 participants must be recruited from a single centre for the trial to continue."

Answered by AI

Has the regulatory arm of the government sanctioned 68Ga-PSMA-11 for public use?

"After careful consideration, the team at Power assigned a score of 2 to 68Ga-PSMA-11's safety rating as there is evidence that it can be safely administered but no proof of its effectiveness."

Answered by AI

Is it still possible to enroll in this research endeavor?

"Affirmative. According to the clinicaltrials.gov website, this medical experiment which was first posted on September 28th 2021 is actively recruiting participants. 110 subjects are needed at a single site for the study's completion."

Answered by AI

Has the potential of 68Ga-PSMA-11 been explored through additional research studies?

"Currently, 15 clinical investigations are being conducted with 68Ga-PSMA-11 and 3 of these trials have entered Phase 3. While Iowa City, IA is a major hub for research into this drug, there are 19 trial sites across the US offering access to it."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
68Ga-PSMA-11 PET for the Diagnosis of Metastatic Castration Resistant Prostate Cancer
Thomas Hope 2021. "68Ga-PSMA-11 PET for the Diagnosis of Metastatic Castration Resistant Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04716725.
~4 spots leftby Apr 2025
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