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Radioisotope

99mTc-PSMA Imaging for Prostate Cancer

Phase < 1

Recruiting

Led By Jeremie Calais, MD

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 PCa (primary or recurrent disease)

Men who can provide oral and written informed consent

Must not have

Technically inaccessible nodal location

Patients who started any PCa treatment between study enrollment and surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a PSMA-targeted radioisotope called 99mTc-PSMA-I&S to see if it can help guide doctors to detect prostate cancer that has spread to the lymph nodes.

Who is the study for?

This trial is for men with prostate cancer (new or recurring) who are set to have surgery to remove lymph nodes in the pelvis. They must show positive lymph node disease on a specific PET/CT scan and be able to follow study procedures. Men already treated for prostate cancer between enrollment and surgery, or with hard-to-reach nodal locations can't join.

What is being tested?

The study tests a new method using an imaging agent called 99mTc-PSMA-I&S during surgery to see if it helps find and guide the removal of cancerous lymph nodes by emitting a signal that doctors can detect with special equipment.

What are the potential side effects?

As this is an exploratory study focusing on imaging techniques, side effects may include reactions related to the injection of the imaging agent such as mild pain or discomfort at the injection site.

Eligibility Criteria

Inclusion Criteria

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

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I am a man with prostate cancer (either newly diagnosed or recurrent).

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I am a man who can understand and agree to the study's terms.

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I am a man scheduled for surgery to remove lymph nodes in my pelvis.

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My PET/CT scan shows lymph node involvement in my cancer.

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I am a man who had a PSMA PET/CT scan for cancer staging.

Exclusion Criteria

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

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My cancer has spread to a place doctors can't easily reach.

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I started prostate cancer treatment between joining the study and surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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 (99mTc-PSMA-I&S, SPECT/CT)Experimental Treatment3 Interventions

The first 5 patients receive an initial dose of undergo 99mTc-PSMA-I\&S IV followed by 5 SPECT/CT scans at 3-5, 5-20, 17-21, 25-29, and 40-46 hours later. These 5 patients then receive a second dose of 99mTc-PSMA-I\&S IV and then undergo standard of care surgery. All subsequent patients receive one dose of 99mTc-PSMA-I\&S IV before standard of care surgery.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Computed Tomography

2017

Completed Phase 2

~2790

Single Photon Emission Computed Tomography

2008

Completed Phase 4

~320