PSMA-PET to Guide Prostatectomy

Launched by FIVE ELEVEN PHARMA, INC. · May 15, 2022

Keywords

ClinConnect Summary

This clinical trial, titled "PSMA-PET to Guide Prostatectomy," is studying the best way to prepare for surgery in men with significant prostate cancer. The trial will involve 288 participants who will be randomly assigned to one of two groups: one group will receive the standard MRI scan before surgery, while the other group will get both the standard MRI and a special scan called a PSMA PET scan. The goal is to see if adding the PSMA PET scan can help doctors better plan the surgery and improve patient outcomes by comparing the imaging results to the actual findings from surgery.

To be eligible for this trial, participants must have specific types of prostate cancer and should not have serious erectile dysfunction, as they wish to maintain their ability to have erections after treatment. They also need to be scheduled for surgery within the next 90 days and have either had an MRI recently or be willing to undergo one at no cost. Participants can expect thorough imaging and monitoring throughout the study, and their safety will be closely watched by the medical team. This trial is important because it could lead to better surgical planning and outcomes for men undergoing treatment for prostate cancer.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• 1. Significant prostate cancer:
• • Gleason 3+4 ≥1 core with pattern 4 ≥20%
• • Gleason 3+4 ≥1 core with ≥50% total involvement of core OR ≥3 cores of Gleason 3+4 OR
• • NCCN unfavorable intermediate risk OR
• • Any Gleason 4+3, 4+4, 4+5, 5+4, or 5+5 AND
• • 2. Baseline sexual function (IIEF-EF \> 17): No erectile dysfunction OR mild-to- moderate erectile dysfunction (International Index of Erectile Function Domain ≥ 17) AND
• • 3. The patient desires to maintain erections following treatment
• • 4. Planned to undergo a standard of care MRI or recently completed standard of care MRI within 6 months of scheduled date of surgery. Note: For subjects whose SOC MRI is not within 6 months or not 3Tesla, they may be enrolled in the study and the MRI will be repeated as a research study. The research MRI will not be billed to the subject's insurance, but will be scheduled at IU ORI, at no cost to study participant.
• • 5. Planned Prostatectomy candidate per treating oncologist with prostatectomy planned within 90 days of consent.
• 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 is not allowed, since MRI is required for comparison).
• • 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.