PSMA-PET to Guide Prostatectomy

Prostate Cancer Clinical Trial

Official title:

PSMA-PET to Guide Prostatectomy: A Randomized Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05381103
• Other study ID #: IU_CLN02_EPE
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: October 1, 2021
• Est. completion date: March 31, 2028

Study information

• Verified date: February 2024
• Source: Five Eleven Pharma, Inc.
• Contact: Jennifer Lehman
• Phone: 317-274-1791
• Email: jgeck[@]iu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 288
• Est. completion date: March 31, 2028
• Est. primary completion date: December 1, 2027
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Diagnostic Test:
• 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

Locations

Country	Name	City	State
United States	Goodman Hall, Indiana Institute for Biomedical Imaging Sciences, Indiana University School of Medicine	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Five Eleven Pharma, Inc.	Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IIEF-EF sub scale score	International Index Erectile Function-Erectile Function sub scale score. Maximum score is 30 with higher score indicating better outcomes.	1 month
Primary	IIEF-EF sub scale score	International Index Erectile Function-Erectile Function sub scale score. Maximum score is 30 with higher score indicating better outcomes.	3 months
Primary	IIEF-EF sub scale score	International Index Erectile Function-Erectile Function sub scale score. Maximum score is 30 with higher score indicating better outcomes.	6 months
Primary	IIEF-EF sub scale score	International Index Erectile Function-Erectile Function sub scale score. Maximum score is 30 with higher score indicating better outcomes.	12 months
Primary	IIEF-EF sub scale score	International Index Erectile Function-Erectile Function sub scale score. Maximum score is 30 with higher score indicating better outcomes.	18 months
Secondary	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	1 month
Secondary	Ratio of positive surgical margins to nerve bundles spared		1 month
Secondary	EPE detection	Sensitivity/Specificity for extra-prostatic extension of cancer at the nerve bundles	1 month
Secondary	Incontinence bother	Expanded Prostate Cancer Index Composite (EPIC-26) questions 1-2	18 months
Secondary	Incontinence: using 0-1 pads per day	Expanded Prostate Cancer Index Composite (EPIC-26) question 3	18 months
Secondary	Urgency/frequency	Expanded Prostate Cancer Index Composite (EPIC-26) questions 4-5	18 months
Secondary	Erectile dysfunction: ability to achieve erection sufficient for penetration	IIEF question 3	18 months
Secondary	Overall mental and physical health	Short Form quality of life questionnaire (SF-36)	18 months
Secondary	Surgical margins	postive surgical margin rates	1 month