The Role of 68Ga-PSMA-11 PET (Prostate Specific Membrane Antigen) in Surgery Guidance in Prostate Cancer

Clinton Bahler

Status and phase: Completed; Phase 2

Conditions: Prostate Cancer

Treatments: Diagnostic Test: 68Ga-PSMA-11 PET Scan

Study type: Interventional

Funder types: Other

Identifiers

NCT04936334

IUSCCC-0760

Details and patient eligibility

About

Obtain PSMA-PET imaging preoperatively and calculate performance for predicting extra-prostatic extension based on whole-mount pathology (gold standard).

Quantify the frequency of proper treatment changes directed by PSMA-PET, focusing on appropriate preservation of surrounding structures important for genito-urinary function including: 1) Bladder neck, 2) Nerve bundles, 3) Urethral Sphincter (Figure 4).

Directly compare PSMA-PET performance for predicting extra-prostatic extension to standard-of-care assessments.

Assess quality of life changes from preoperative baseline.

Enrollment: 51 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 1. Men diagnosed with clinically significant prostate cancer who are scheduled or scheduling for prostatectomy 2. Prostate pathology results consistent with:

  2. > 3 cores of Gleason 3+4 or

  3. NCCN unfavorable intermediate risk or

  4. NCCN high-risk or

  5. NCCN very-high risk 3. Scheduled for standard of care MRI or has recently completed standard of care MRI (within 6 months).

Willing and able to lie still for approximately 50 minutes in an enclosed space for the PET/CT and MRI

Exclusion criteria

• 1. Participation in another investigational trial involving research exposure to ionizing radiation concurrently or within 30 days.

  2. Does not meet safety criteria for MRI scan (e.g. metal implant that could affect prostate imaging).

  3. Significant acute or chronic medical, neurologic, or illness in the subject that, in the judgment of the Principal Investigator, could compromise subject safety, limit the ability to complete the study, and/or compromise the objectives of the study.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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51 participants in 1 patient group

Men diagnosed with clinically significant prostate cancer who are scheduled for prostatectomy

Experimental group

Description:

1. Men diagnosed with clinically significant prostate cancer who are scheduled or for prostatectomy will undergo injection of 68Ga-PSMA-11 at the time of their pre-treatment PSMA PET. Followed until 12 mo post surgery

Treatment:

Diagnostic Test: 68Ga-PSMA-11 PET Scan