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68Ga-PSMA-11 PET Scan for Prostate Cancer
Phase 2
Recruiting
Led By Delphine L. Chen, M.D.
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of metastatic castration-resistant prostate cancer
Ability to understand and willingness to provide informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years post-scan
Awards & highlights
Study Summary
This trial is testing how well a 68Ga-PSMA-11 PET/CT scan works in detecting prostate cancer. The scan may improve monitoring of treatment response.
Who is the study for?
Men with prostate cancer who have had surgery or radiation therapy and show signs of the cancer returning, as indicated by rising PSA levels. They must not have other cancers within the last 2 years (with some exceptions) and should be in a stable physical condition with a performance status indicating they can carry out daily activities without significant limitations.Check my eligibility
What is being tested?
The trial is testing how effective a new type of PET scan called 68Ga-PSMA-11 is at detecting prostate cancer compared to standard imaging techniques. It aims to improve diagnosis and monitoring of treatment response in patients showing signs of recurrent prostate cancer.See study design
What are the potential side effects?
While this trial focuses on diagnostic imaging rather than drug treatment, potential side effects may include discomfort during the scanning process, allergic reactions to contrast agents used for MRI or CT scans, and exposure to radiation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My prostate cancer has spread and is not responding to hormone therapy.
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I can understand and agree to participate in the study.
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My prostate cancer is aggressive or my PSA level is over 20.
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My PSA levels are increasing after having surgery or local treatments for prostate cancer.
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My PSA levels have risen by 2 mg/mL or more after radiation therapy.
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I can take care of myself but may not be able to do active work.
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I have been diagnosed with prostate cancer.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years post-scan
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years post-scan
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in planned management strategy
Secondary outcome measures
68Ga-PSMA-11 standard uptake value normalized to lean body mass (SULpeak)
68Ga-PSMA-11 standardized uptake value maximum (SUVmax)
Change in 68Ga-PSMA-11 SULpeak
+5 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Diagnostic (Gallium Ga 68-labeled PSMA-11, PET/CT, PET/MR)Experimental Treatment4 Interventions
Patients receive gallium Ga 68-labeled PSMA-11 IV then undergo PET/CT or PET/MR scan over 2-4 minutes per bed position at baseline. Patients receiving systemic therapy undergo an additional 68Ga-PSMA-11 PET/CT or PET/MR scan 12 weeks after initiating therapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Computed Tomography
2017
Completed Phase 2
~2720
Positron Emission Tomography
2008
Completed Phase 2
~2240
Gallium Ga 68 Gozetotide
2020
Completed Phase 3
~1750
Find a Location
Who is running the clinical trial?
University of WashingtonLead Sponsor
1,741 Previous Clinical Trials
1,847,553 Total Patients Enrolled
18 Trials studying Prostate Cancer
8,244 Patients Enrolled for Prostate Cancer
Delphine L. Chen, M.D.Principal InvestigatorFred Hutch/University of Washington Cancer Consortium
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My PSA levels are above 0.2 ng/mL after prostate surgery, indicating a recurrence.I do not have any serious illnesses or social situations that would stop me from following the study's requirements.My prostate cancer has spread and is not responding to hormone therapy.I haven't had any cancer except for certain skin, bladder cancers, or very early stage leukemia in the past 2 years.I have a lesion that imaging tests couldn't clearly identify.I can understand and agree to participate in the study.My prostate cancer is aggressive or my PSA level is over 20.My PSA levels are increasing after having surgery or local treatments for prostate cancer.My PSA levels have risen by 2 mg/mL or more after radiation therapy.I can take care of myself but may not be able to do active work.I have been diagnosed with prostate cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Diagnostic (Gallium Ga 68-labeled PSMA-11, PET/CT, PET/MR)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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 big is the sample size for this research project?
"That is correct. The official website for this clinical trial indicates that it is still looking for participants. This specific study was originally posted on May 17th, 2021 and was last edited on September 26th, 2022. In total, they are hoping to have 150 patients from 1 location."
Answered by AI
Has Positron Emission Tomography received the green light from the FDA?
"Positron Emission Tomography receives a safety score of 2 from our team at Power. This is due to it being in Phase 2 trials, which have provided some evidence that the intervention is safe, but not effective."
Answered by AI
What types of illnesses does Positron Emission Tomography help with most often?
"Positron Emission Tomography can be used to effectively manage prostate cancer, eczema, dyshidrotic and psoriasis."
Answered by AI
Are there any more spots open in this clinical trial for people who want to participate?
"That is accurate. The clinicaltrials.gov website has the most recent information on this trial, which was created on May 17th, 2021 and last updated September 26th, 2022. They are looking for 150 patients at a single site."
Answered by AI
Could you please list other times when PET scans have been used in research?
"Positron Emission Tomography is being trialled in 21 different studies, 3 of which are Phase 3 clinical trials. The majority of these studies are centred in Iowa City, but there are active 25 research sites across the United States."
Answered by AI
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