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Screening (18F-rhPSMA-7.3 PET/MRI) for Prostate Cancer

N/A

Waitlist Available

Led By Ram A. Pathak, M.D.

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male subjects with at least age 30 to 85

Planned elective radical prostatectomy with extended pelvic lymph node dissection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 120 months

Awards & highlights

Study Summary

This trial aims to use a new imaging scan called 18F-rhPSMA-7.3 PET/MRI to identify patients at risk of their prostate cancer spreading to the lymph nodes. This

Who is the study for?

This trial is for men with high-risk prostate cancer that hasn't spread beyond the prostate. They're looking at how well a new type of PET/MRI scan can predict if the cancer has reached the lymph nodes, which could help decide if patients need further surgery to remove these nodes.Check my eligibility

What is being tested?

The study tests an imaging technique using a radioactive substance (18F-rhPSMA-7.3) combined with PET and MRI scans to detect potential spread of prostate cancer to lymph nodes in patients who are already scheduled for radical prostatectomy.See study design

What are the potential side effects?

Potential side effects may include reactions to the radioactive tracer used in the PET scan or discomfort from lying still during imaging procedures like MRI and CT scans.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a man aged between 30 and 85.

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I am scheduled for a major prostate surgery with lymph node removal.

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I have prostate cancer and am scheduled for surgery to remove it.

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My cancer has spread to less than 3 areas, as shown by a specific scan.

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I have high-risk prostate cancer that hasn't been treated yet.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 120 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 120 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 120 months 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 of flotufolastat F-18 gallium (18F-rhPSMA-7.3) positron emission tomography (PET)/magnetic resonance (MRI) for the detection of lymph node metastasis

Secondary outcome measures

Digital rectal examination

Gleason score

Number of patients where management has changed

+4 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Screening (18F-rhPSMA-7.3 PET/MRI)Experimental Treatment9 Interventions

Patients receive 18F-rhPSMA-7.3 IV and undergo PET/MRI up to 30 days prior to SOC robotic radical prostatectomy with bilateral pelvic lymph node dissection. Patients also undergo CT or MRI, bone scan and tissue collection during screening.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Computed Tomography

2017

Completed Phase 2

~2720

Positron Emission Tomography

2008

Completed Phase 2

~2240

Biospecimen Collection

2004

Completed Phase 2

~1700

Magnetic Resonance Imaging

2017

Completed Phase 3

~1190

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,227 Previous Clinical Trials

3,771,618 Total Patients Enrolled

34 Trials studying Prostate Cancer

8,388 Patients Enrolled for Prostate Cancer

Ram A. Pathak, M.D.Principal InvestigatorMayo Clinic

Frequently Asked Questions

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

Does this medical study have an age inclusion criterion that encompasses individuals who are 70 years of age or older?

"Individuals aged between 30 and 85 are eligible for participation in this research endeavor. Notably, there exist a total of 142 studies dedicated to individuals below the age of legal adulthood, whereas a larger number of trials - specifically 3808 - cater to those who have surpassed their 65th year."

Answered by AI

Is enrollment still open for this ongoing research study?

"As per clinicaltrials.gov, the ongoing medical investigation posted on 5/31/2024 is not actively seeking participants. Despite this trial being closed for enrollment currently, there are a substantial number of 3837 other studies currently open and recruiting patients."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Accuracy of 18F-rhPSMA-7.3 PET/ MRI for Prediction of Lymph Node Metastasis in Localized High-Risk Prostate Cancer

2024. "Accuracy of 18F-rhPSMA-7.3 PET/ MRI for Prediction of Lymph Node Metastasis in Localized High-Risk Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06389786.