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Diagnostic Test
PSMA PET Scan for Prostate Cancer
Phase 2
Waitlist Available
Led By William Aronson, MD
Research Sponsored by VA Greater Los Angeles Healthcare System
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
Study Summary
This trial will compare two imaging techniques to see if one helps detect prostate cancer more accurately than the other.
Who is the study for?
This trial is for men with suspected clinically significant prostate cancer, indicated by a PI-RADS score of 4-5 from an mpMRI. Participants must have had this imaging within the last 9 months and be willing to undergo a biopsy. They should be able to consent and agree to random assignment in the study but cannot join if under 18 or have health issues that could affect their participation.Check my eligibility
What is being tested?
The study is testing whether combining PSMA PET scans with mpMRI can better detect important prostate cancers compared to using mpMRI alone. It's a phase 2 trial where patients are randomly chosen to either get just an mpMRI or an additional DCFPyL PET/CT scan.See study design
What are the potential side effects?
Potential side effects may include reactions at the injection site from the radiotracer (18F-DCFPyl), discomfort during imaging procedures, and possible allergic reactions, although specific side effects will depend on individual patient responses.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Detection of Clinically Significant Prostate Cancer
Secondary outcome measures
Adverse Events Associated with 18F- DCFPyl
Correlation of AI Measures with Aggressiveness of Prostate Cancer
Correlation of PSMA PET intensity with Clinically Significant Prostate Cancer
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: PSMA PET+mpMRIExperimental Treatment2 Interventions
PSMA PET+mpMRI guided prostate biopsy
Group II: mpMRI onlyActive Control1 Intervention
mpMRI only guided prostate biopsy
Find a Location
Who is running the clinical trial?
VA Greater Los Angeles Healthcare SystemLead Sponsor
51 Previous Clinical Trials
8,469 Total Patients Enrolled
3 Trials studying Prostate Cancer
517 Patients Enrolled for Prostate Cancer
Lantheus Medical ImagingIndustry Sponsor
56 Previous Clinical Trials
4,332,576 Total Patients Enrolled
4 Trials studying Prostate Cancer
1,583 Patients Enrolled for Prostate Cancer
William Aronson, MDPrincipal InvestigatorVA Greater Los Angeles Healthcare System
3 Previous Clinical Trials
100 Total Patients Enrolled
3 Trials studying Prostate Cancer
100 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a high-risk prostate lesion and will have a biopsy.I am under 18 years old.My kidney function is good enough for a prostate MRI.I had a prostate MRI within the last 9 months.I can sign and understand the consent form.I am willing to undergo either a prostate MRI or a prostate MRI plus a DCFPyL PET/CT scan.
Research Study Groups:
This trial has the following groups:- Group 1: PSMA PET+mpMRI
- Group 2: mpMRI only
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.
Does this research project need additional participants?
"The study in question is not presently recruiting patients, as per the details on clinicaltrials.gov which reflects the trial's first posting being 5/1/2023 and last update occurring 4/6/2023. However, there are over twelve hundred other medical trials currently welcoming enrolment across fields of research."
Answered by AI
Has Arm 1 received authorization from the FDA?
"Early evidence suggests that Arm 1 is relatively safe, so it was assigned a rating of 2. This evaluation comes from the fact that this study is currently in Phase 2 and no efficacy data has yet been collected."
Answered by AI
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