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PSMA-PET CT Imaging for Prostate Cancer (ESCAPE Trial)

N/A

Recruiting

Led By Timothy Mcclure, M.D.

Research Sponsored by Weill Medical College of Cornell University

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 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will study if a non-invasive imaging test can detect prostate cancer that would need treatment in men on active surveillance.

Who is the study for?

Men over 18 with low or favorable intermediate-risk prostate cancer, as defined by NCCN guidelines, can join. They must have a PSA level under 20 ng/ml and be able to undergo yearly PSMA-PET CT scans, prostate biopsies, and mpMRI. Those not interested in active surveillance or with prior treatments for prostate cancer cannot participate.

What is being tested?

The trial is testing the effectiveness of PSMA-PET CT scans in monitoring patients with low to intermediate-risk prostate cancer who are on active surveillance. The goal is to see if this imaging technique can reliably detect the absence of significant cancer progression.

What are the potential side effects?

While the document does not specify side effects related to PSMA-PET CT scans directly, generally such procedures may include discomfort at injection site, allergic reaction to contrast agents used during imaging, and exposure to radiation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Negative predictive value (NPV)

Secondary study objectives

Number of negative scans on PSMA-PET

Number of negative scans on both PSMA-PET and mpMRI

Number of negative scans on mpMRI

+7 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: PSMA-PET CTExperimental Treatment1 Intervention

Patients will undergo PSMA-PET CT (Prostate Specific Membrane Antigen Positron Emission Tomography-Computed Tomography) at baseline, 12 month and 24 month time point.

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