RecruitingNot ApplicableNCT07348367

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

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


Sponsor

Henry Ford Health System

Enrollment

160 participants

Start Date

Jan 12, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Sex: MALE

Plain Language Summary

Simplified for easier understanding

This study is comparing two types of prostate surgery: the standard radical prostatectomy (removal of the entire prostate) versus a newer precision prostatectomy that removes only the cancerous part of the prostate. The goal is to see if the precision approach has better outcomes for sexual function and urinary control while still treating the cancer effectively. **You may be eligible if...** - You have prostate cancer being treated at Henry Ford Health - Your PSA is 20 ng/mL or below - Your cancer is at stage T2 or below (localized) - Your Gleason score is 4+3 or lower on one side, with no high-grade cancer on the other side - You have good baseline sexual function (SHIM score of 17 or higher) **You may NOT be eligible if...** - You have had hormone therapy in the past 6 months - Your cancer has spread to lymph nodes or elsewhere in the body - You have had previous prostate cancer treatment (radiation, HIFU, etc.) - You have other cancers or serious conditions limiting your life expectancy to under 5 years Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURERadical Prostatectomy

In radical prostatectomies, the entire prostate as well as much of the surrounding tissue is removed.

PROCEDUREPrecision 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.


Locations(1)

Henry Ford Health

Detroit, Michigan, United States

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NCT07348367


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