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NCT Number: NCT05155501

Clinical Trial of Approaches to Prostate Cancer Surgery

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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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

40 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Beckman Research Institute of City of Hope, Duarte, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Robot-assisted radical prostatectomy (RP)

Procedure

The conventional approach to prostate cancer surgery

Pelvic fascia-sparing robot-assisted radical prostatectomy (PFS-RP)

Procedure

A novel, posterior approach to radical prostatectomy that preserves the dorsal vascular complex, nerves and fascial support structures that overlie the anterior prostate.

Primary outcomes

  1. Surgical Margin Status as assessed by surgical pathology results

    Time frame: 1 week post-surgery

    Presence of cancer cells at the prostate margin is standardized as a positive surgical margin through professional guideline consensus.

  2. Biochemical Recurrence as assessed by Prostate Specific Antigen (PSA)

    Time frame: 6 months post-surgery

    Prostate specific antigen (PSA) levels are obtained from standard of care blood tests, and PSA values are measured in ng/mL.

    In accordance with National Comprehensive Cancer Network (NCCN) guidelines, investigators will capture PSA persistence as failure of PSA to fall to undetectable levels, and PSA recurrence as an undetectable PSA after surgery with a subsequent detectable PSA that increases on 2 or more determinations.

  3. Biochemical Recurrence as assessed by Prostate Specific Antigen (PSA)

    Time frame: 12 months post-surgery

    Prostate specific antigen (PSA) levels are obtained from standard of care blood tests, and PSA values are measured in ng/mL.

  4. Biochemical Recurrence as assessed by Prostate Specific Antigen (PSA)

    Time frame: 24 months post-surgery

    Prostate specific antigen (PSA) levels are obtained from standard of care blood tests, and PSA values are measured in ng/mL.

Secondary outcomes

  1. Surgery-Related Adverse Events as assessed by the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)

    Time frame: Up to 30 days following surgery

    The questionnaire will include 20 items from the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE), survey items pertinent to short-stay cancer surgery.

    The questionnaire will assess patient-reported complications and adverse events, such as constipation, nausea and vomiting, fever, chills, fatigue, pain, shortness of breath, swelling and bruising, redness and discharge at the surgical incision site, anxiety, and flatulence (ileus). It will also assess patient contacts with physicians and admittance to urgent care or the emergency room.

  2. Change in Urinary and Sexual Function, as measured by the Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP)

    Time frame: Baseline, 1 month, 6 months, 12 months, and 24 months post-surgery

    The Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP) is a 7-item questionnaire assessing two health-related quality of life domains: urinary and sexual function. All questions refer to patients' health and symptoms in the last four weeks.

    Each domain is scored out of 12 points, with higher scores indicating more complications.

    In total, the EPIC-CP score is the final sum of the two domains, with higher scores indicating more issues related to overall prostate cancer quality of life.

  3. Change in Patient-Reported Penile Shortening and Sexual Function, as measured by a 5-item questionnaire

    Time frame: Baseline, 1 month, 6 months, 12 months, and 24 months post-surgery

    This is a 5-item questionnaire, published in the New England Journal of Medicine (NEJM), that has face validity for assessing penile shortening, self-esteem, and erectile function after radical prostatectomy.

    Question 1 assesses patients' perceived penile length post-surgery, compared to penile length at 30 years of age. It consists of two possible responses: Yes or No.

    Questions 2 and 3 assesses patients' ability to obtain and quality of spontaneous morning erections and sexual activity-related erections. It consists of five possible responses: ranging from "No erections" to "Erections always sufficient".

    Question 4 is a visual digital scale assessing patients' present quality of life. It is scored on a scale of 1-7, with higher scores indicating high quality of life.

    Question 5 is a visual digital scale assessing patients' present self-esteem. It is scored on a scale of 1-7, with higher scores indicating high self-esteem.

  4. Change in patient-Reported Penile Curvature/Deformity (Peyronie's Disease), as measured by a 3-item questionnaire

    Time frame: Baseline, 1 month, 6 months, 12 months, and 24 months post-surgery

    This is a validated, 3-item questionnaire assessing presence of Peyronie's disease. The penile deformity items were validated by blinded clinical examination with 100% sensitivity and 99.4% specificity.

    Question 1 assesses penile hardening/plaques in the flaccid state. Question 2 assesses penile curvature in the erect state. Question 3 assesses pain associated with erection. Each question consists of two possible responses: Yes or No.

  5. Patient-reported Decision Regret, as measured by a 5-item questionnaire

    Time frame: 12 months post-surgery

    This is a 5-item questionnaire assessing treatment regret that was developed and validated in men with prostate cancer.

    Each item is scored on a 5 point scale ranging from "Strongly Agree" to "Strongly Disagree". Responses are converted to a score ranging from 0-100, with higher scores indicating more regret.

  6. Patient-reported Decision Regret, as measured by a 5-item questionnaire

    Time frame: 24 months post-surgery

    This is a 5-item questionnaire assessing treatment regret that was developed and validated in men with prostate cancer.

Study contacts

Contact information is provided by the study sponsor or research team.

May Ting, MBS

CONTACT

[email protected]

732-757-2448

Xiaohong Jing, PhD

CONTACT

[email protected]

212-746-4739

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Collaborators

  • National Cancer Institute (NCI)
  • National Institutes of Health (NIH)

Registry information

Acronym: PARTIAL

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Dec 13, 2021
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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