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PSMA-PET to Guide Prostatectomy

Primary Purpose

Prostate Cancer

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
PSMA-PET and SOC MRI
SOC MRI
Sponsored by
Five Eleven Pharma, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostate Cancer

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Men diagnosed with prostate cancer who choose radical prostatectomy
  • Significant prostate cancer: Gleason 3+4 ≥1 core with pattern 4 ≥20% OR ≥3 cores of Gleason 3+4 OR Any Gleason 4+3, 4+4, 4+5, 5+4, or 5+5 AND
  • Baseline sexual function (IIEF-EF ≥ 17): No erectile dysfunction OR mild erectile dysfunction OR mild-to-moderate erectile dysfunction (International Index of Erectile Function-Erectile Function domain ≥ 17). AND
  • The patient desires to maintain erections following treatment.

Exclusion Criteria:

  • Participation in another investigational trial involving research exposure to ionizing radiation concurrently or within 30 days
  • Patient is unable to tolerate remaining still on the bed of the PET or MRI camera, due to physical limitations or claustrophobia.
  • c. Significant acute or chronic medical condition in the subject that could compromise the objectives of the study.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PSMA-PET and SOC MRI prior to surgery

SOC MRI prior to surgery

Arm Description

Outcomes

Primary Outcome Measures

IIEF-EF sub scale score
International Index Erectile Function-Erectile Function sub scale score. Maximum score is 30 with higher score indicating better outcomes.
IIEF-EF sub scale score
International Index Erectile Function-Erectile Function sub scale score. Maximum score is 30 with higher score indicating better outcomes.
IIEF-EF sub scale score
International Index Erectile Function-Erectile Function sub scale score. Maximum score is 30 with higher score indicating better outcomes.
IIEF-EF sub scale score
International Index Erectile Function-Erectile Function sub scale score. Maximum score is 30 with higher score indicating better outcomes.
IIEF-EF sub scale score
International Index Erectile Function-Erectile Function sub scale score. Maximum score is 30 with higher score indicating better outcomes.

Secondary Outcome Measures

Change in treatment plan
Proportion of patients whose treatment plan would be changed by PSMA-PET. Treatment changes are defined as any change in surgical resection plan that affects one of 4 critical regions for quality of life
Ratio of positive surgical margins to nerve bundles spared
EPE detection
Sensitivity/Specificity for extra-prostatic extension of cancer at the nerve bundles
Incontinence bother
Expanded Prostate Cancer Index Composite (EPIC-26) questions 1-2
Incontinence: using 0-1 pads per day
Expanded Prostate Cancer Index Composite (EPIC-26) question 3
Urgency/frequency
Expanded Prostate Cancer Index Composite (EPIC-26) questions 4-5
Erectile dysfunction: ability to achieve erection sufficient for penetration
IIEF question 3
Overall mental and physical health
Short Form quality of life questionnaire (SF-36)
Surgical margins
postive surgical margin rates

Full Information

First Posted
April 29, 2022
Last Updated
May 16, 2023
Sponsor
Five Eleven Pharma, Inc.
Collaborators
Indiana University
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1. Study Identification

Unique Protocol Identification Number
NCT05381103
Brief Title
PSMA-PET to Guide Prostatectomy
Official Title
PSMA-PET to Guide Prostatectomy: A Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 8, 2022 (Actual)
Primary Completion Date
August 1, 2027 (Anticipated)
Study Completion Date
December 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Five Eleven Pharma, Inc.
Collaborators
Indiana University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
In this study, 288 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
288 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PSMA-PET and SOC MRI prior to surgery
Arm Type
Experimental
Arm Title
SOC MRI prior to surgery
Arm Type
Active Comparator
Intervention Type
Diagnostic Test
Intervention Name(s)
PSMA-PET and SOC MRI
Intervention Description
60 min continuous acquisition of PET data after 3-6 mCI injection of [68Ga]P16-093 followed by contrast-CT
Intervention Type
Diagnostic Test
Intervention Name(s)
SOC MRI
Intervention Description
Standard of care MRI
Primary Outcome Measure Information:
Title
IIEF-EF sub scale score
Description
International Index Erectile Function-Erectile Function sub scale score. Maximum score is 30 with higher score indicating better outcomes.
Time Frame
1 month
Title
IIEF-EF sub scale score
Description
International Index Erectile Function-Erectile Function sub scale score. Maximum score is 30 with higher score indicating better outcomes.
Time Frame
3 months
Title
IIEF-EF sub scale score
Description
International Index Erectile Function-Erectile Function sub scale score. Maximum score is 30 with higher score indicating better outcomes.
Time Frame
6 months
Title
IIEF-EF sub scale score
Description
International Index Erectile Function-Erectile Function sub scale score. Maximum score is 30 with higher score indicating better outcomes.
Time Frame
12 months
Title
IIEF-EF sub scale score
Description
International Index Erectile Function-Erectile Function sub scale score. Maximum score is 30 with higher score indicating better outcomes.
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Change in treatment plan
Description
Proportion of patients whose treatment plan would be changed by PSMA-PET. Treatment changes are defined as any change in surgical resection plan that affects one of 4 critical regions for quality of life
Time Frame
1 month
Title
Ratio of positive surgical margins to nerve bundles spared
Time Frame
1 month
Title
EPE detection
Description
Sensitivity/Specificity for extra-prostatic extension of cancer at the nerve bundles
Time Frame
1 month
Title
Incontinence bother
Description
Expanded Prostate Cancer Index Composite (EPIC-26) questions 1-2
Time Frame
18 months
Title
Incontinence: using 0-1 pads per day
Description
Expanded Prostate Cancer Index Composite (EPIC-26) question 3
Time Frame
18 months
Title
Urgency/frequency
Description
Expanded Prostate Cancer Index Composite (EPIC-26) questions 4-5
Time Frame
18 months
Title
Erectile dysfunction: ability to achieve erection sufficient for penetration
Description
IIEF question 3
Time Frame
18 months
Title
Overall mental and physical health
Description
Short Form quality of life questionnaire (SF-36)
Time Frame
18 months
Title
Surgical margins
Description
postive surgical margin rates
Time Frame
1 month

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men diagnosed with prostate cancer who choose radical prostatectomy Significant prostate cancer: Gleason 3+4 ≥1 core with pattern 4 ≥20% OR ≥3 cores of Gleason 3+4 OR Any Gleason 4+3, 4+4, 4+5, 5+4, or 5+5 AND Baseline sexual function (IIEF-EF ≥ 17): No erectile dysfunction OR mild erectile dysfunction OR mild-to-moderate erectile dysfunction (International Index of Erectile Function-Erectile Function domain ≥ 17). AND The patient desires to maintain erections following treatment. Exclusion Criteria: Participation in another investigational trial involving research exposure to ionizing radiation concurrently or within 30 days Patient is unable to tolerate remaining still on the bed of the PET or MRI camera, due to physical limitations or claustrophobia. c. Significant acute or chronic medical condition in the subject that could compromise the objectives of the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer Lehman
Phone
317-274-1791
Email
jgeck@iu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinton Bahler, MD
Organizational Affiliation
Indiana University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Goodman Hall, Indiana Institute for Biomedical Imaging Sciences, Indiana University School of Medicine
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Green, Ph.D

12. IPD Sharing Statement

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PSMA-PET to Guide Prostatectomy

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