PSMA-PET for Biopsy and Treatment Guidance in Primary Prostate Cancer

Completed · Phase 2

Conditions studied: Prostate Cancer

In brief

The overall objective of this Early Phase Clinical Trial is to begin defining the accuracy of 68Ga-PSMA-11 for detecting the location and size of clinically significant prostate cancer lesions in low and intermediate risk disease. A molecularly-targeted probe (68Ga-PSMA-11), coupled with an advanced clinical imaging system (Siemens Biograph VisionPET-CT), will improve accuracy during biopsy and staging. We propose detailed intra-lesion whole-mount pathologic analysis as the gold standard for critically assessing PSMA PET accuracy in patients undergoing surgery, and blinded PSMA PET-CT comparison with standard multi-parametric MRI (mpMRI) for patients having biopsy on active surveillance. This intensive testing of the accuracy and value of PSMA-based tracers requires our unique collaboration of surgeons, radiologists, pathologists, and imaging scientists with decades of experience and innovation.

Key facts

Study ID

NCT03429244

Run by

Indiana University

People needed

36

Starts

2019-04-15

Expected to finish

2022-05-01

Last updated by the study team

2023-05-08

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• ≥ 18 years of age
• Must provide written informed consent
• Presence of low or intermediate risk prostate cancer or at risk of having intermediate risk cancer
• a. Intermediate risk prostate cancer: i. Grade group 2 = 3 + 4, or ii. Grade group 3 = 4 + 3 b. At Risk of intermediate risk prostate cancer: i. 4K score ≥ 20%, or ii. Select MDx ≥ 20%, or iii. PSA Density ≥ 0.15 iv. Grade group 1= 3+3 (iv. Note: Where multiple cancer lesions are present on biopsy, it is allowable to have Gleason 8 or 9 cancer lesions if they are in addition to the intermediate risk cancer as described above.)
• Scheduled for MRI or has recently completed SOC MRI (within 6 months) for further biopsy, or surgical removal, or focal therapy.
• Willing and able to lie still for approximately 50 minutes in an enclosed space for the CT.

You may not qualify if…

• Participation in another investigational trial involving research exposure to ionizing radiation concurrently or within 30 days.
• Does not meet safety criteria for MRI scan (e.g. metal implant that is not allowed).
• Significant acute or chronic medical, neurologic, or psychiatric illness in the subject that, in the judgment of the Principal Investigator, could compromise subject safety, limit the subject's ability to complete the study, and/or compromise the objectives of the study.

Where it is running

• Indiana University Health North Hospital — Carmel, Indiana, United States
• Indiana University Health Hospital — Indianapolis, Indiana, United States
• Indiana University Health Methodist Hospital — Indianapolis, Indiana, United States
• Indiana University Melvin and Bren Simon Cancer Center — Indianapolis, Indiana, United States

Full record on ClinicalTrials.gov

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