68Ga-PSMA-11 for Hormone-Refractory Prostate Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Hormone-Refractory Prostate Cancer+4 More68Ga-PSMA-11 - Drug
Eligibility
18+
Male
What conditions do you have?
Select

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.

Eligible Conditions
  • Hormone-Refractory Prostate Cancer
  • Stage IVB Prostate Cancer
  • Stage IV Prostate Cancer
  • Stage IVA Prostate Cancer
  • Castration-Resistant Prostate Cancer

Treatment Effectiveness

Study Objectives

4 Primary · 4 Secondary · Reporting Duration: Up to 24 months

Week 16
Comparison between mean percent change in SUVmax with Prostate-specific antigen (PSA) response group
Comparison between mean percent change in SUVmax with objective response group
Comparison between mean percent change in maximum standard uptake value (SUVmax) with Prostate-specific antigen (PSA) response group
Comparison between mean percent change in maximum standard uptake value (SUVmax) with objective response group
Mean maximum standard uptake value (SUVmax)
Median SUVmax
Up to 24 months
Comparison of Change in SUVmax-ave Group on Overall Survival (OS)
Comparison of Change in SUVmax-ave Group on Progression Free Survival (PFS)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

1 Treatment Group

Experimental (68Ga-PSMA-11 PET)
1 of 1

Experimental Treatment

110 Total Participants · 1 Treatment Group

Primary Treatment: 68Ga-PSMA-11 · No Placebo Group · Phase 2

Experimental (68Ga-PSMA-11 PET)Experimental Group · 2 Interventions: 68Ga-PSMA-11, Positron Emission Tomography (PET) · Intervention Types: Drug, Procedure
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gallium Ga-68 gozetotide
FDA approved
Positron Emission Tomography (PET)
2019
Completed Phase 4
~1320

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 24 months

Who is running the clinical trial?

Conquer Cancer FoundationOTHER
14 Previous Clinical Trials
3,338 Total Patients Enrolled
Prostate Cancer FoundationOTHER
38 Previous Clinical Trials
1,984 Total Patients Enrolled
University of California, San FranciscoLead Sponsor
2,282 Previous Clinical Trials
11,577,499 Total Patients Enrolled
Gateway for Cancer ResearchOTHER
35 Previous Clinical Trials
2,103 Total Patients Enrolled
Rahul R Aggarwal, MDPrincipal InvestigatorUniversity of California, San Francisco
2 Previous Clinical Trials
114 Total Patients Enrolled
Ivan A de Kouchovsky, MDPrincipal InvestigatorUniversity of California, San Francisco

Eligibility Criteria

Age 18+ · Male Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Patients must have baseline evaluations performed within 12 weeks prior to the start of systemic therapy.
You have progressive castration resistant prostate cancer.
Patients must have planned initiation of systemic treatment (sub-cohort A1), or ongoing systemic treatment (sub-cohort A2) for castration resistant prostate cancer within 12 weeks of baseline Ga-PSMA PET.
You have a performance status of 0 or 1.
You are 18 years or older.