Prostate Cancer Clinical Trial

Clinical Trial of Approaches to Prostate Cancer Surgery

Summary

This is a prospective, randomized controlled trial to compare cancer control and health-related quality of life following pelvic fascia-sparing radical prostatectomy versus standard radical prostatectomy.

The investigators hypothesize that pelvic fascia-sparing radical prostatectomy will have similar cancer control (primary outcome) and sexual function outcomes; and significantly better urinary function, penile shortening/deformity and inguinal hernia risks as compared to radical prostatectomy.

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Full Description

Traditional radical prostatectomy is the most popular treatment for clinically significant prostate cancer, however significant risks including urinary incontinence, erectile dysfunction, penile shortening, penile curvature/ deformation (Peyronie's disease), and inguinal hernia, are common. Pelvic fascia-sparing radical prostatectomy is a new surgical technique that may preserve fascial support structures, arterial supply to the penis, and nerves that are severed and resected during conventional radical prostatectomy.

This study will enroll adult men undergoing radical prostatectomy for clinically localized prostate cancer. Subjects will be randomized to receive either radical prostatectomy or pelvic fascia-sparing radical prostatectomy. Investigators will compare cancer control and health-related quality of life outcomes through patient questionnaires and medical record review.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Male sex
Age ≥40 years or ≤80 years
Scheduled for radical prostatectomy for clinically localized prostate cancer
Able to read and speak English or Spanish
Willingness to sign informed consent and adhere to the study protocol

Exclusion Criteria:

Prior major pelvic surgery or radiotherapy
Suspicion of N1 disease (i.e., any lymph node greater than 1cm in maximal diameter)

Study is for people with:

Prostate Cancer

Estimated Enrollment:

600

Study ID:

NCT05155501

Recruitment Status:

Recruiting

Sponsor:

Weill Medical College of Cornell University

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There are 4 Locations for this study

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Georgetown University
Washington District of Columbia, 20007, United States More Info
Keith Kowalczyk, MD
Contact
[email protected]
Keith Kowalczyk, MD
Principal Investigator
Northwestern University
Chicago Illinois, 60611, United States More Info
Mary Kate Keeter, MPH
Contact
312-694-6082
[email protected]
Edward M Schaeffer, MD PhD
Principal Investigator
Johns Hopkins University
Baltimore Maryland, 21287, United States More Info
Rana Harb, MS
Contact
410-502-5500
[email protected]
Mohamad E Allaf, MD
Principal Investigator
Weill Cornell Medicine
New York New York, 10065, United States More Info
Jim C Hu, MD MPH
Contact
646-962-9600
[email protected]

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Estimated Enrollment:

600

Study ID:

NCT05155501

Recruitment Status:

Recruiting

Sponsor:


Weill Medical College of Cornell University

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