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Radiopharmaceutical
PSMA-11 PET/CT Imaging for Recurrent Prostate Cancer (PSMA SRT Trial)
Phase 3
Waitlist Available
Led By Jeremie Calais
Research Sponsored by Jonsson Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histopathology proven prostate cancer
Planned SRT for recurrence after primary prostatectomy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
PSMA SRT Trial Summary
This trial is testing a new way to find and diagnose prostate cancer that has come back after surgery, using a solution that is taken up by cancer cells. The hope is that this will help doctors plan better for salvage radiation therapy in participants with recurrent prostate cancer.
Who is the study for?
This trial is for men with prostate cancer recurrence post-surgery, who are willing to undergo radiotherapy. They must have a PSA level of at least 0.1 ng/ml and agree that their treatment plan may include findings from the PET/CT scan. Men currently on hormone therapy or with inflammatory bowel disease, extra-pelvic metastasis, or using other investigational drugs can't participate.Check my eligibility
What is being tested?
The study tests if a diagnostic procedure using Gallium Ga 68-labeled PSMA-11 (a substance taken up by cancer cells) combined with PET/CT scans can help in planning salvage radiation therapy for recurrent prostate cancer after surgery.See study design
What are the potential side effects?
While this trial focuses on diagnosis rather than treatment, potential side effects could relate to the imaging process such as allergic reactions to tracers or discomfort from lying still during the PET/CT scan.
PSMA SRT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My prostate cancer diagnosis was confirmed through tissue examination.
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I am scheduled for radiation therapy after prostate surgery due to cancer recurrence.
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I am willing to undergo radiotherapy.
PSMA SRT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Success rate of salvage radiation therapy (SRT)
Secondary outcome measures
Biochemical progression-free survival rate
Change in initial treatment intent
Initiation of additional salvage therapy after completion of SRT
+1 morePSMA SRT Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm II (68Ga-PSMA-11 PET/CT)Experimental Treatment3 Interventions
Participants receive 68Ga-PSMA-11 IV and 50-100 minutes later undergo whole-body (skull base to mid-thighs) PET/CT. Participants then undergo SRT per the discretion of the treating radiation oncologist.
Group II: Arm I (standard of care)Active Control1 Intervention
Participants receive standard of care SRT.
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
~2240
Computed Tomography
2017
Completed Phase 2
~2720
Find a Location
Who is running the clinical trial?
Jonsson Comprehensive Cancer CenterLead Sponsor
359 Previous Clinical Trials
25,857 Total Patients Enrolled
39 Trials studying Prostate Cancer
4,000 Patients Enrolled for Prostate Cancer
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,474 Total Patients Enrolled
561 Trials studying Prostate Cancer
507,173 Patients Enrolled for Prostate Cancer
Jeremie CalaisPrincipal InvestigatorUCLA / Jonsson Comprehensive Cancer Center
7 Previous Clinical Trials
1,180 Total Patients Enrolled
4 Trials studying Prostate Cancer
1,087 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot undergo radiotherapy due to certain health conditions like active inflammatory bowel disease.My cancer has spread beyond the pelvic area.My prostate cancer diagnosis was confirmed through tissue examination.I am scheduled for radiation therapy after prostate surgery due to cancer recurrence.My doctor will use 68Ga-PSMA-11 PET/CT scan results in my radiotherapy plan.I am willing to undergo radiotherapy.I have started hormone therapy for prostate cancer within the last 3 months.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (standard of care)
- Group 2: Arm II (68Ga-PSMA-11 PET/CT)
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How much of a threat does Gallium Ga 68-labeled PSMA-11 pose to patients?
"Gallium Ga 68-labeled PSMA-11 is estimated to be a safe as it has progressed to Phase 3 in clinical trials. This suggests that not only is there data supporting its efficacy, but also that it has undergone multiple rounds of testing for safety."
Answered by AI
Are people still being signed up for this experiment?
"According to the latest update on clinicaltrials.gov, this particular trial is not looking for any more participants at the moment. The study was first posted on July 12th, 2018 and was last updated February 2nd, 2020. There are however 1289 other trials that are actively recruiting patients right now."
Answered by AI
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