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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-11

Study Completion Date

2022-07-19

Brief Summary

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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.

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Detailed Description

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Conditions

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Prostate Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

68Ga-PSMA-11 PET will be performed and we will study how the knowledge of the results informs treatment decisions versus the treatment decisions with only MRI knowledge.

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Two separate radiologists (one from Nuclear Medicine and one from MRI) will read images in a blinded fashion and provide their findings for the surgeons to use in treatment planning.

Study Groups

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

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

Group Type EXPERIMENTAL

68Ga-PSMA-11 PET Scan

Intervention Type DIAGNOSTIC_TEST

Patients will undergo injection of 68Ga-PSMA-11 at the time of their pre treatment PSMA PET scan and followed until 12 months post surgery.

Interventions

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68Ga-PSMA-11 PET Scan

Patients will undergo injection of 68Ga-PSMA-11 at the time of their pre treatment PSMA PET scan and followed until 12 months post surgery.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

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

1. \> 3 cores of Gleason 3+4 or
2. NCCN unfavorable intermediate risk or
3. NCCN high-risk or
4. 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.

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No