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Cancer Imaging Agent
rhPSMA-7.3 PET/CT Imaging for Prostate Cancer
Phase 3
Waitlist Available
Led By Laurence Belkoff, DO, FACOS
Research Sponsored by MidLantic Urology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient willing to provide signed informed consent and willing to comply with all required study schedule events, where safe and feasible.
Patient is male and aged >18 years old.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 15 months
Awards & highlights
Study Summary
This trial studies if imaging can detect metastases in men w/ high-risk prostate cancer & if it changes medical management.
Who is the study for?
This trial is for men with high-risk prostate cancer who have already undergone standard imaging tests. It's not specified who can't join, but typically those with health issues that could interfere with the study or allergies to the imaging agent might be excluded.Check my eligibility
What is being tested?
The trial is testing a new diagnostic imaging method using rhPSMA-7.3 (18F) PET/CT scans in detecting metastatic lesions in men with high-risk prostate cancer after they've had conventional imaging.See study design
What are the potential side effects?
Since this is an imaging study, side effects may include reactions to the tracer rhPSMA-7.3 (18F), such as mild irritation at the injection site or allergic reactions, though specific side effects are not detailed here.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 15 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~15 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Prostate cancer upstaging
Secondary outcome measures
Metastasis detection rate
Metastasis detection rate with negative imaging
Positive predictive value of rhPSMA compared to biopsy
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: rhPSMA-7.3Experimental Treatment1 Intervention
Role of rhPSMA-7.3 PET/CT imaging in men with High-Risk prostate cancer following conventional imaging and associated changes in medical management
Find a Location
Who is running the clinical trial?
MidLantic UrologyLead Sponsor
Blue Earth DiagnosticsIndustry Sponsor
38 Previous Clinical Trials
2,874 Total Patients Enrolled
10 Trials studying Prostate Cancer
1,214 Patients Enrolled for Prostate Cancer
Laurence Belkoff, DO, FACOSPrincipal InvestigatorMidLantic Urology
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:Research Study Groups:
This trial has the following groups:- Group 1: rhPSMA-7.3
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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.
Has the FDA granted authorization for rhPSMA-7.3?
"Our experts at Power have assigned rhPSMA-7.3 a score of 3; indicative of the fact that there is ample clinical evidence to support both efficacy and safety in this Phase 3 trial."
Answered by AI
Are any enrollees currently being accepted for participation in this experiment?
"Per the details hosted on clinicaltrials.gov, this medical trial is not accepting patients at the moment; it was first posted on April 27th 2023 and last updated March 22nd 2023. Despite this, 1313 additional studies are currently recruiting participants."
Answered by AI
Who else is applying?
What portion of applicants met pre-screening criteria?
Did not meet criteria
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