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

Henry Ford Health

Status: Enrolling

Conditions: Prostatectomy

Treatments: Procedure: Precision Prostatectomy; Procedure: Radical Prostatectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT07348367

18404-01

Details and patient eligibility

About

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.

Enrollment: 160 estimated patients

Sex: Male

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 2 patient groups

Radical Prostatectomy

Active Comparator group

Description:

This arm is the control arm and consists of the current standard of care. Patients in this arm receive a radical prostatectomy.

Treatment:

Procedure: Radical Prostatectomy

Precision Prostatectomy

Experimental group

Description:

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

Treatment:

Procedure: Precision Prostatectomy