RecruitingNot Applicable

Clinical Trial of Approaches to Prostate Cancer Surgery

United States600 participantsStarted 2023-05-15

Plain-language 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.

Who can participate

Age range40 Years – 80 Years

SexMALE

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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)

What they're measuring

Surgical Margin Status as assessed by surgical pathology results

Timeframe: 1 week post-surgery

Biochemical Recurrence as assessed by Prostate Specific Antigen (PSA)

Timeframe: 6 months post-surgery

Biochemical Recurrence as assessed by Prostate Specific Antigen (PSA)

Timeframe: 12 months post-surgery

Biochemical Recurrence as assessed by Prostate Specific Antigen (PSA)

Timeframe: 24 months post-surgery

Trial details

NCT IDNCT05155501

SponsorWeill Medical College of Cornell University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-07

Contact for this trial

May Ting, MBS

732-757-2448 mat7051@med.cornell.edu

View on ClinicalTrials.gov More Prostate Cancer trials