Recruiting
Phase 2
Phase 3

PSMA-PET

Sponsor:

Five Eleven Pharma, Inc.

Code:

NCT05381103

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

PSMA-PET and SOC MRI

SOC MRI

Study Details

Brief summary:

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.

Conditions

Prostate Cancer

Study ID

NCT05381103

Start date

Oct 1, 2021

Status verified date

Oct, 2024

Completion date

Dec 1, 2028

Anticipated

Primary completion date

Jun 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 40 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

288 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: PSMA-PET and SOC MRI prior to surgery

active comparator: SOC MRI prior to surgery

Interventions

PSMA-PET and SOC MRI

60 min continuous acquisition of PET data after 3-6 mCI injection of \[68Ga\]P16-093 followed by contrast-CT

SOC MRI

Standard of care MRI

Primary outcome measure

  • IIEF-EF sub scale score [ Time Frame: 1 month ]
  • IIEF-EF sub scale score [ Time Frame: 3 months ]
  • IIEF-EF sub scale score [ Time Frame: 6 months ]
  • IIEF-EF sub scale score [ Time Frame: 12 months ]
  • IIEF-EF sub scale score [ Time Frame: 18 months ]

Central Contacts and Locations

Central contacts

Locations

Goodman Hall, Indiana Institute for Biomedical Imaging Sciences, Indiana University School of Medicine

Recruiting

Indianapolis, Indiana, United States, 46202

More Information

Sponsor

Five Eleven Pharma, Inc.

Last update posted

Jan 31, 2025

Last verified

Oct, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Five Eleven Pharma, Inc. on 2025-01-31.