A Comparison of Radical Prostatectomy and Precision Prostatectomy in Low- and Intermediate-risk Prostate Cancers.

January 12, 2026 updated by: Firas Abdollah, Henry Ford Health System

A Randomized Comparison of Radical Prostatectomy and Precision Prostatectomy in Low- and Intermediate-risk Prostate Cancers.

Prostate cancer (PCa) management for low- and intermediate-risk patients often involves radical prostatectomy (RP), which achieves oncologic control but is associated with significant functional impairments, such as erectile dysfunction (50-70%) and urinary incontinence (5-20%). To address these issues, precision prostatectomy (PP) has emerged as a novel surgical approach that preserves functional structures while removing >90% of prostate tissue.

PP is thought to provide superior functional outcomes with acceptable oncological control by preserving the capsule, seminal vesicle (SV), and the surrounding neuronal nitric oxide synthase (nNOS) producing nerves on the side opposite to the dominant nodule while maximizing prostatic tissue removal. Early reports of PP demonstrate promising functional outcomes, with 90% of patients retaining sexual potency (Sexual Health Inventory for Men [SHIM] score ≥17) and 100% achieving continence (0-1 pads/day) by 12 months postoperatively. Importantly, PP only requires a different surgical technique, no more equipment, time, or labor is required. This means that there is no additional charge to patients, and it is covered the same by health insurance.

While there are early results suggesting the superiority of PP, no randomized trials have yet to be performed. This study has two main aims: to demonstrate superiority of PP in terms of functional recovery while also establishing non-inferiority in oncologic outcomes compared to RP. This dual objective reflects the potential of PP to improve quality of life without compromising cancer control.

Eligible patients will be randomized to either RP, which is the current standard of care, or PP using random blocked randomization using the Zelen design.

The outcomes of interest will be measured at 12 months post-surgery. Functional outcomes will be measured using SHIM scores at 12 months and the number of pads used per day. Meanwhile, oncological outcomes will be measured by whether patients have received secondary prostate cancer treatment at 12 months post-surgery. These items are collected as part of standard of care of all patients 12 months after prostatectomy. RP and PP patients' sexual function recovery (SHIM ≥17 vs SHIM < 17), as well as the proportion reaching continence (≤1 pad per day, > 1 pad per day) will be compared.

RP has been shown to be effective in terms of oncological outcomes, though it has also been shown to be related to incontinence and erectile dysfunction. Early results have suggested that PP is superior in terms of functional outcomes while being as good as RP in terms of oncological outcomes, though no randomized trials have been conducted. This trial will address this literature gap and could lead to patients receiving care that is as effective ontologically and superior in terms of functional recovery as the current standard of care. This could lead to improved quality of life for patients after surgery. Considering that prostate cancer is the most common non-cutaneous carcinoma among men in the United States, this has the potential to help thousands of men per year by improving their quality of life without sacrificing oncological outcomes.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Health
        • Contact:
        • Contact:
        • Principal Investigator:
          • Firas Abdollah, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Prostate cancer patients receiving treatment at Henry Ford Health from the investigator or co-investigator who opt for surgery.
  • Prostate-specific antigen (PSA) ≤20 ng/mL
  • Clinical stage ≤cT2
  • Dominant unilateral lesion with Gleason ≤4+3 on biopsy
  • No Gleason ≥4 contralaterally
  • Preoperative SHIM score ≥17 (with or without phosphodiesterase-5 inhibitor use)

Exclusion Criteria:

  • • Androgen deprivation therapy within 6 months.

    • Nodal positive disease
    • Metastatic disease
    • Prior prostate cancer therapy (e.g., radiation, HIFU).
    • Significant comorbidities precluding surgery or life expectancy <5 years as defined by the Prostate Cancer Comorbidity Index [5].
    • Any previous cancer diagnosis.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Radical Prostatectomy
This arm is the control arm and consists of the current standard of care. Patients in this arm receive a radical prostatectomy.
Procedure: Radical Prostatectomy
In radical prostatectomies, the entire prostate as well as much of the surrounding tissue is removed.
Other Names:
  • Prostatectomy
Experimental: Precision Prostatectomy
This arm is the treatment arm and consists of patients who receive a Precision Prostatectomy.
Procedure: Precision Prostatectomy
The surgical approach is very similar to a radical prostatectomy. The difference is that in precision prostatectomy, some of the prostate, including the nerves which might be integral to continence and erectile function are protected and not removed, unlike with traditional radical prostatectomies.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sexual Health
Time Frame: Before surgery, 3 months post-surgery, 12 months post-surgery
Patients' sexual health and function is measured by the Sexual Health Inventory for Men (SHIM). A SHIM score > 16 is considered sexually healthy.
Before surgery, 3 months post-surgery, 12 months post-surgery
Social Continence
Time Frame: 12 months post-surgery.
Continence is determined by the number of pads used per day by patients. Social continence is defined as < 2 pads per day.
12 months post-surgery.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oncological outcomes
Time Frame: 12-months post-surgery
The number of patients who undergo secondary treatment.
12-months post-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Henry Ford Health System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 12, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

September 30, 2025

First Submitted That Met QC Criteria

January 12, 2026

First Posted (Estimated)

January 16, 2026

Study Record Updates

Last Update Posted (Estimated)

January 16, 2026

Last Update Submitted That Met QC Criteria

January 12, 2026

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18404-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

At this time we do not plan on making a deidentified dataset and PHI cannot be shared per institutional policies. We will consider sharing deidentified data upon request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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