RightFit
RecruitingNot applicable

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.

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
No age limits stated
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares surgery to remove the whole prostate with precision surgery, which removes more than 90% while saving some nearby tissues and nerves. It is for people with low- or medium-risk prostate cancer who choose surgery. The study tests whether precision surgery helps people keep erections and bladder control while controlling cancer as well as standard surgery.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Choose surgery and receive prostate cancer care at Henry Ford Health from a doctor leading the study.
  • Have a PSA blood test result of 20 ng/mL or less. PSA is a protein made by the prostate.
  • Have cancer at stage cT2 or lower, meaning it appears limited to the prostate.
  • Have the main cancer area on one side, with a biopsy Gleason score of 4+3 or lower. This score describes how abnormal cancer cells look.
  • Have no Gleason grade 4 or higher cancer on the other side of the prostate.
  • Have a SHIM score of at least 17 before surgery, with or without erection medicine. SHIM measures how well you can get and keep erections.

Who can't join

  • Had treatment to lower male hormones within the past 6 months.
  • Have cancer in the lymph nodes.
  • Have cancer that has spread to distant parts of the body.
  • Had prostate cancer treatment before, such as radiation or high-intensity focused ultrasound (HIFU).
  • Have other serious health problems that make surgery unsafe, or are expected to live less than 5 years based on the study's health scoring tool.
  • Have any past cancer diagnosis.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (1)

MI