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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04936334
Other study ID # IUSCCC-0760
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date June 11, 2021
Est. completion date July 19, 2022

Study information

Verified date August 2023
Source Indiana University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 51
Est. completion date July 19, 2022
Est. primary completion date July 18, 2022
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
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.

Locations

Country Name City State
United States Indiana University Health University Hospital Indianapolis Indiana

Sponsors (1)

Lead Sponsor Collaborator
Clinton Bahler

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Sensitivity of PSMA-PET and MRI Imaging Preoperatively for Predicting Extra-prostatic Extension Sensitivity detecting extra-prostatic extension of cancer at the nerve bundles The patients underwent a 60minute PET exam. The surgery was generally performed within 1month of the PET scan. The pathology was done 5-10 days after the surgery.
Primary Specificity of PSMA-PET and MRI Specificity of PSMA-PET and MRI to detect Extra-prostatic extension prior to prostatectomy. Whole mount pathology is used as the reference standard. Pre-surgery prediction.
Secondary 1) Quantify the Frequency of Proper Treatment Changes for Nerve Sparing Directed by PSMA-PET Rate of treatment changes 60 Days
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