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Prostate CancerPARTIALNCT05155501

Clinical Trial of Approaches to Prostate Cancer Surgery

A study testing Robot-assisted radical prostatectomy (RP) and Pelvic fascia-sparing robot-assisted radical prostatectomy (PFS-RP) in people with Prostate Cancer, run by Weill Medical College of Cornell University at 9 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 to 80 years, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Robot-assisted radical prostatectomy (RP) and Pelvic fascia-sparing robot-assisted radical prostatectomy (PFS-RP)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
600 participants
Where
9 sitesUnited States
Study dates
15 May 2023to Jul 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 80 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

9 sites in 1 country. Contact the study team or a site near you to ask about taking part.

May Ting, MBS contact

732-757-2448

mat7051@med.cornell.edu

Xiaohong Jing, PhD contact

212-746-4739

xij2004@med.cornell.edu

9 sites in 1 country

United States9 sites, 9 recruiting

  • Johns Hopkins University

    Baltimore, Maryland, 21287

    Rana Harb, MS, 410-502-5500, rharb1@jhmi.edu

    Mohamad E Allaf, MD

    Recruiting

  • Beth Israel Deaconess Medical Center (BIDMC)

    Boston, Massachusetts, 02215

    Gabriela Nieto Blanco, MS, 617-632-1047, gnietobl@bidmc.harvard.edu

    Sarah Duncan, BA, sduncan1@bidmc.harvard.edu

    Recruiting

  • Northwestern University

    Chicago, Illinois, 60611

    Mary Kate Keeter, MPH, 312-694-6082, mary.fitzgerald@northwestern.edu

    Edward M Schaeffer, MD PhD

    Recruiting

  • Beckman Research Institute of City of Hope

    Duarte, California, 91010

    Radhika Nagalla, PharmD, 847-502-0334, rnagalla@coh.org

    Clayton Lau, MD

    Recruiting

  • NewYork-Presbyterian Queens

    Flushing, New York, 11355

    Neal Patel, MD, 718-303-3720, nap9055@med.cornell.edu

    Neal Patel, MD

    Recruiting

  • Hackensack Meridian Health

    Hackensack, New Jersey, 07601

    Samanta Baboolall-Aracena, 551-996-3960, samanta.baboolallaracena@hmhn.org

    Nitin Yerram, MD

    Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

    Melissa McCarter, mccartem@mskcc.org

    Behfar Ehdaie, MD

    Recruiting

  • Weill Cornell Medicine

    New York, New York, 10065

    Jim C Hu, MD MPH, 646-962-9600, jch9011@med.cornell.edu

    Recruiting

  • Georgetown University

    Washington D.C., District of Columbia, 20007

    Keith Kowalczyk, MD, Keith.Kowalczyk@medstar.net

    Keith Kowalczyk, MD

    Recruiting

Other trials in United States

About this study

Official title: 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.

Read the detailed 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.

Conditions
Prostate Cancer
Being tested
Robot-assisted radical prostatectomy (RP), Pelvic fascia-sparing robot-assisted radical prostatectomy (PFS-RP)
Keywords
radical prostatectomy, nerve sparing, Retzius sparing
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Robot-assisted radical prostatectomy (RP)Procedure or surgery

    The conventional approach to prostate cancer surgery

  • Pelvic fascia-sparing robot-assisted radical prostatectomy (PFS-RP)Procedure or surgery

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

Study groups in NCT05155501
Study groupRoleWhat they receive
Robot-assisted radical prostatectomy (RP)Active comparatorThe conventional robotic-assisted radical prostatectomy is the gold standard approach to prostate cancer surgery.
Receives: Procedure: Robot-assisted radical prostatectomy (RP)
Pelvic fascia-sparing robot-assisted radical prostatectomy (PFS-RP)ExperimentalA novel, posterior approach to radical prostatectomy that preserves the dorsal vascular complex, nerves and fascial support structures that overlie the anterior prostate. These structures are disrupted and removed during conventional radical prostatectomy.
Receives: Procedure: Pelvic fascia-sparing robot-assisted radical prostatectomy (PFS-RP)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Surgical Margin Status as assessed by surgical pathology results

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

    Measured: 1 week post-surgery

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

    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.

    Measured: 6 months post-surgery

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

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

    Measured: 12 months post-surgery

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

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

    Measured: 24 months post-surgery

Secondary outcomes (6)

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

    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.

    Measured: Up to 30 days following surgery

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

    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.

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

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

    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.

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

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

    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.

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

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

    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.

    Measured: 12 months post-surgery

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

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

    Measured: 24 months post-surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Dec 2021
  2. Study start15 May 2023
  3. Primary completionJul 2028 (estimated)
  4. Study completionJul 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05155501
Sponsor's protocol ID
21-07023781
Other IDs
1R01CA259173
Acronym
PARTIAL
Status last verified
Apr 2026
First submitted
30 Nov 2021
Last updated
22 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Stangl-Kremser J, Kowalczyk K, Schaeffer EM, Allaf M, Scherr D, Yang X, Matoso A, Azumi N, Robinson B, Vickers A, Hu JC. Study protocol for a prospective, multi-centered randomized controlled trial comparing pelvic fascia-sparing radical prostatectomy with conventional robotic-assisted prostatectomy: The PARTIAL trial. Contemp Clin Trials. 2023 May;128:107168. doi: 10.1016/j.cct.2023.107168. Epub 2023 Apr 2.

    PubMed 37015291

Questions about this trial

What is this clinical trial studying?

A study testing Robot-assisted radical prostatectomy (RP) and Pelvic fascia-sparing robot-assisted radical prostatectomy (PFS-RP) in people with Prostate Cancer, run by Weill Medical College of Cornell University at 9 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact May Ting, MBS (732-757-2448, mat7051@med.cornell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Surgical Margin Status as assessed by surgical pathology results (time frame: 1 week post-surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05155501, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.

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