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Clinical Trial of Approaches to Prostate Cancer Surgery

Clinical TrIAL of Approaches to Prostate cAncer suRgery

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
40 Years to 80 Years
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Investigators will compare cancer control and health-related quality of life outcomes through patient questionnaires and medical record review."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares two ways to remove the prostate: one that saves a layer of tissue around it and standard surgery. It is for men with prostate cancer that has not spread beyond the prostate, and it compares cancer control and effects on daily life, including sexual and bladder function.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Male.
  • The age rule says “40 or older or 80 or younger.” Ask the study team to confirm what this means.
  • Scheduled for surgery to remove the prostate for cancer that has not spread beyond it.
  • Able to read and speak English or Spanish.
  • Willing to sign a form agreeing to join and follow the study rules.

Who can't join

  • Past major surgery or radiation treatment in the pelvis, the lower belly area.
  • Possible cancer spread to nearby lymph nodes, small structures that help fight infection. The study defines this as any lymph node larger than 1 centimeter across.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 sites (9)

CA

DC

IL

MA

MD

NJ

NY