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PSMA-PET/CT Guided Biopsy for Prostate Cancer

Phase < 1

Recruiting

Led By Jeremie Calais

Research Sponsored by Jonsson Comprehensive Cancer Center

Eligibility Criteria Checklist

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

Must have

Men with suspicion of clinically significant prostate cancer with prior inconclusive, discordant or negative magnetic resonance imaging/ultrasound (MRI/US) fusion prostate biopsy

Focal 68Ga-PSMA-11 uptake within the prostate

Must not have

Age < 18 and > 90 years

Known inability to remain still and lie flat for the duration of the PET/CT (about 30 minutes)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new way to do a prostate biopsy, using a PSMA protein found on prostate cancer cells. The new biopsy is done with a PET/CT scan and may help improve the detection rate of prostate cancer.

Who is the study for?

This trial is for men who are suspected to have clinically significant prostate cancer but had previous inconclusive or negative biopsies. They must show focal uptake of a tracer in the prostate and be scheduled for another biopsy. Men under 18, over 90, or unable to lie still for PET/CT scans cannot participate.

What is being tested?

The study tests if using a radioactive imaging agent called 68Ga-PSMA-11 with PET/CT scans can better diagnose prostate cancer during biopsies after earlier tests failed to confirm the disease.

What are the potential side effects?

Potential side effects may include discomfort from the biopsy procedure, reactions to the imaging agent like mild nausea or rash, and exposure to radiation from the PET/CT scan.

Eligibility Criteria

Inclusion Criteria

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

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I am a man who might have serious prostate cancer, but my previous prostate biopsy was unclear or negative.

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My prostate cancer shows up on a specific PET scan.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am younger than 18 or older than 90.

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I can stay still and lie flat for 30 minutes.

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My prostate cancer has come back.

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

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

Primary study objectives

Detection rate of clinically significant prostate cancer

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: Diagnostic (68Ga-PSMA-11, image-guided prostate biopsy)Experimental Treatment3 Interventions

SCREENING PROCEDURE: Patients receive 68Ga-PSMA-11 IV and 50-100 minutes later, undergo a PET/CT scan. Only patients with 68Ga-PSMA-11 uptake within the prostate proceed to image-guided biopsy. IMAGE-GUIDED BIOPSY: Patients undergo experimental image-guided prostate biopsy using PET/CT images obtained during screening procedure during a standard of care TRUS.

0 / 5Eligibility criteria met