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Positron Emission Tomography for Prostate Cancer

Phase 2

Waitlist Available

Research Sponsored by Andrei Iagaru

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 up to 3 years

Awards & highlights

Study Summary

This trial uses a 68Ga-RM2 PET/CT scan to detect regional nodal and distant metastases in patients with intermediate or high-risk prostate cancer. This scan may be able to see smaller tumors than the standard of care CT or MRI scan.

Eligible Conditions

Prostate Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Sensitivity, Specificity, Positive, and Negative Predictive Value of 68Ga-RM2 PET for the Detection of Regional Nodal Metastases Compared to Pathology at Radical Prostatectomy

Secondary outcome measures

Sensitivity, Specificity, Negative and Positive Predictive Value for Detection of Regional Nodal Metastases in Comparison to Cross Sectional Imaging Performed Contemporaneously With the 68Ga-RM2 PET

Other outcome measures

Incidence of Osseous and Distant Metastatic Lesions

Maximum Standardized Uptake Value (SUVmax) From 68Ga-RM2 PET

PSA Progression Free Survival

Trial Design

1Treatment groups

Experimental Treatment

Group I: Diagnostic (68Ga-RM2 PET/CT)Experimental Treatment4 Interventions

Patients receive 68Ga-RM2 IV. Within 45-60 minutes, patients undergo a PET/CT scan. Patients may undergo a second PET/CT scan immediately after the first scan for attenuation correction. Patients may undergo also a repeat 68Ga-RM2 PET/CT scan after the completion of their treatment to evaluate response to therapy, if requested by the treating physician.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Gallium Ga 68-labeled GRPR Antagonist BAY86-7548

2017

Completed Phase 2

~50

Positron Emission Tomography

2008

Completed Phase 2

~2240

Computed Tomography

2017

Completed Phase 2

~2720

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Andrei IagaruLead Sponsor

15 Previous Clinical Trials

552 Total Patients Enrolled

3 Trials studying Prostate Cancer

32 Patients Enrolled for Prostate Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has any research previously been conducted utilizing Laboratory Biomarker Analysis?

"At this time, 1 clinical research project is underway analysing laboratory biomarkers. Of these studies, none are in the final Phase 3 of testing; however there is one location conducting trials related to this treatment based in Palo Alto, California."

Answered by AI

Are there any availability for enrollment in this research project?

"This trial is no longer recruiting. It was first listed on the 10th of April, 2017 and last updated on June 14th 2022. As an alternative, there are currently 1964 trials actively enrolling participants with prostate cancer as well as one study involving laboratory biomarker analysis that seeks new patients."

Answered by AI

Could you evaluate the potential risks of Laboratory Biomarker Analysis for patients?

"Our team at Power assigned Laboratory Biomarker Analysis a score of two, as there is some evidence to suggest its safety but no data available regarding efficacy."

Answered by AI

What is the numerical scope of patients partaking in this experiment?

"At this time, no patients are being accepted for the aforementioned clinical trial, which was initially listed on April 10th of 2017 and last edited on June 14th of 2022. Fortunately, 1964 studies related to prostate cancer have open registration periods as well as 1 laboratory biomarker analysis study that is looking for participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

68Ga-RM2 PET/CT in Detecting Regional Nodal and Distant Metastases in Patients With Intermediate or High-Risk Prostate Cancer

Andrei Iagaru 2017. "68Ga-RM2 PET/CT in Detecting Regional Nodal and Distant Metastases in Patients With Intermediate or High-Risk Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03113617.