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

NCT07348367 | Recruiting

• 1 other identifier: 18404-01
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostatectomy

Keywords

Prostate Cancer; Prostatectomy

Outcome Measures

Primary Outcomes (2)

• Sexual Health

  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

  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 Outcomes (1)

• Oncological outcomes

  12-months post-surgery

Study Arms (2)

Radical Prostatectomy

ACTIVE COMPARATOR

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

Precision Prostatectomy

EXPERIMENTAL

This arm is the treatment arm and consists of patients who receive a Precision Prostatectomy.

Procedure: Precision Prostatectomy

Interventions

Radical Prostatectomy PROCEDURE

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

Also known as: Prostatectomy

Radical Prostatectomy

Precision Prostatectomy PROCEDURE

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.

Precision Prostatectomy

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Henry Ford Health System: lead

Study Sites (1)

Henry Ford Health

Detroit, Michigan, 48202, United States

RECRUITING

Related Publications (7)

• Sood A, Jeong W, Keeley J, Abdollah F, Hassan O, Gupta N, Menon M. Subtotal surgical therapy for localized prostate cancer: a single-center precision prostatectomy experience in 25 patients, and SEER-registry data analysis. Transl Androl Urol. 2021 Jul;10(7):3155-3166. doi: 10.21037/tau-20-1476.

  PMID: 34430418 BACKGROUND

• Capogrosso P, Vertosick EA, Benfante NE, Eastham JA, Scardino PJ, Vickers AJ, Mulhall JP. Are We Improving Erectile Function Recovery After Radical Prostatectomy? Analysis of Patients Treated over the Last Decade. Eur Urol. 2019 Feb;75(2):221-228. doi: 10.1016/j.eururo.2018.08.039. Epub 2018 Sep 17.

  PMID: 30237021 BACKGROUND

• Resnick MJ, Koyama T, Fan KH, Albertsen PC, Goodman M, Hamilton AS, Hoffman RM, Potosky AL, Stanford JL, Stroup AM, Van Horn RL, Penson DF. Long-term functional outcomes after treatment for localized prostate cancer. N Engl J Med. 2013 Jan 31;368(5):436-45. doi: 10.1056/NEJMoa1209978.

  PMID: 23363497 BACKGROUND

• Menon M, Shrivastava A, Tewari A, Sarle R, Hemal A, Peabody JO, Vallancien G. Laparoscopic and robot assisted radical prostatectomy: establishment of a structured program and preliminary analysis of outcomes. J Urol. 2002 Sep;168(3):945-9. doi: 10.1016/S0022-5347(05)64548-X.

  PMID: 12187196 BACKGROUND

• Xiao H, Tan F, Goovaerts P, Ali A, Adunlin G, Huang Y, Gwede C. Construction of a comorbidity index for prostate cancer patients linking state cancer registry with inpatient and outpatient data. J Registry Manag. 2013 Winter;40(4):159-64.

  PMID: 24625768 BACKGROUND

• Rosen RC, Cappelleri JC, Smith MD, Lipsky J, Pena BM. Development and evaluation of an abridged, 5-item version of the International Index of Erectile Function (IIEF-5) as a diagnostic tool for erectile dysfunction. Int J Impot Res. 1999 Dec;11(6):319-26. doi: 10.1038/sj.ijir.3900472.

  PMID: 10637462 BACKGROUND

• Sood A, Jeong W, Taneja K, Abdollah F, Palma-Zamora I, Arora S, Gupta N, Menon M. The Precision Prostatectomy: an IDEAL Stage 0, 1 and 2a Study. BMJ Surg Interv Health Technol. 2019 Aug 19;1(1):e000002. doi: 10.1136/bmjsit-2019-000002. eCollection 2019.

  PMID: 35047770 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Prostatectomy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Urologic Surgical Procedures, Male; Urologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative

Central Study Contacts

Firas Abdollah, MD, FEBU

CONTACT

313-673-7463; fabdoll1@hfhs.org

Alex Stephens, MS, MA

CONTACT

313-556-7918; asteph11@hfhs.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., F.E.B.U. Vice-Chair, Academics and Research

Study Record Dates

• First Submitted: September 30, 2025
• First Posted: January 16, 2026
• Study Start: January 12, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: January 16, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)