PSMA-PET to Guide Prostatectomy

Five Eleven Pharma

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Prostate Cancer

Treatments: Diagnostic Test: SOC MRI; Diagnostic Test: PSMA-PET and SOC MRI

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05381103

IU_CLN02_EPE

Details and patient eligibility

About

In this study, 196 patients will be randomized 1:1 to either having only the standard of care MRI prior to surgery versus having the standard of care MRI and the PSMA PET scan. PET (and MRI) findings will be validated against whole mount pathology. Pre-surgical imaging findings will also be evaluated in the context of affecting subsequent surgical plans and impacting actual patient outcomes.

Enrollment: 288 estimated patients

Sex: Male

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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288 participants in 2 patient groups

PSMA-PET and SOC MRI prior to surgery

Experimental group

Treatment:

Diagnostic Test: PSMA-PET and SOC MRI

SOC MRI prior to surgery

Active Comparator group

Treatment:

Diagnostic Test: SOC MRI