Clinical trial NCT05381103: PSMA-PET to Guide Prostatectomy
Official title: PSMA-PET to Guide Prostatectomy: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Prostate Cancer
Lead sponsor: Five Eleven Pharma, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Indiana University
First posted: 2022-05-19
Enrollment: 288
Sex: MALE
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


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.

Primary outcomes:
measure: IIEF-EF sub scale score
timeFrame: 1 month
measure: IIEF-EF sub scale score
timeFrame: 3 months
measure: IIEF-EF sub scale score
timeFrame: 6 months
measure: IIEF-EF sub scale score
timeFrame: 12 months
measure: IIEF-EF sub scale score
timeFrame: 18 months
Secondary outcomes:
measure: Change in treatment plan
timeFrame: 1 month
measure: Ratio of positive surgical margins to nerve bundles spared
timeFrame: 1 month
measure: EPE detection
timeFrame: 1 month
measure: Incontinence bother
timeFrame: 18 months
measure: Incontinence: using 0-1 pads per day
timeFrame: 18 months
measure: Urgency/frequency
timeFrame: 18 months
measure: Erectile dysfunction: ability to achieve erection sufficient for penetration
timeFrame: 18 months
measure: Overall mental and physical health
timeFrame: 18 months
measure: Surgical margins
timeFrame: 1 month
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Goodman Hall, Indiana Institute for Biomedical Imaging Sciences, Indiana University School of Medicine
state: Indiana
Study officials:
affiliation: Indiana University School of Medicine
name: Clinton Bahler, MD
role: PRINCIPAL_INVESTIGATOR
References: