Radical vs Precision Prostatectomy for Prostate Cancer

Overseen By Firas Abdollah, MD, FEBU

Age: Any Age

Sex: Male

Trial Phase: Academic

Sponsor: Henry Ford Health System

Must not be taking: Androgen deprivation

Disqualifiers: Nodal positive, Metastatic, Prior therapy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

160 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new surgical approach for treating prostate cancer. It compares the standard radical prostatectomy, which often causes erectile dysfunction and urinary incontinence, with a new method called precision prostatectomy. Precision prostatectomy aims to improve quality of life by preserving important structures, potentially reducing these side effects while still effectively treating cancer. Men with prostate cancer at Henry Ford Health, who have a specific cancer profile and haven't undergone certain treatments, might be suitable for this study. The goal is to determine if the new surgery matches the standard in cancer control while improving daily life recovery. As an unphased trial, this study offers a unique opportunity to contribute to innovative surgical advancements that could enhance future prostate cancer treatments.

What prior data suggests that this surgical technique is safe for prostate cancer patients?

Research shows that precision prostatectomy (PP) is a safe surgery for prostate cancer patients. Studies indicate that PP effectively controls cancer while preserving important functions. Early findings suggest that PP leads to better sexual function and bladder control compared to traditional surgery. One year after surgery, 90% of PP patients maintained their sexual health, and all patients achieved bladder control, needing no more than one pad per day. There are no extra costs or equipment needed, and insurance covers it like standard surgery. While PP appears promising, further research is needed to confirm these results. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Precision Prostatectomy because it offers a more tailored approach to treating prostate cancer compared to the standard Radical Prostatectomy. Unlike the one-size-fits-all method of radical surgery, Precision Prostatectomy aims to target and remove only the cancerous tissue while sparing healthy tissue. This could potentially lead to fewer side effects, faster recovery times, and improved quality of life for patients. By customizing the surgery to each individual, there's hope for better outcomes and less impact on surrounding structures, which is a significant advancement over the current standard of care.

What evidence suggests that this trial's treatments could be effective for prostate cancer?

This trial will compare Radical Prostatectomy (RP) with Precision Prostatectomy (PP) for treating prostate cancer. Research has shown that Precision Prostatectomy holds promise for treating prostate cancer while preserving important functions. Early results indicate that 90% of patients maintain sexual function, and all patients achieve urinary control 12 months after surgery. This method carefully removes most of the prostate but preserves key structures that help control these functions. Studies suggest PP is as effective in controlling cancer as the traditional Radical Prostatectomy but with fewer side effects. Although no randomized trials have been completed yet, these early findings offer hope for improving quality of life without compromising cancer treatment effectiveness. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

Men with low- to intermediate-risk prostate cancer, PSA ≤20 ng/mL, clinical stage ≤cT2, and a dominant lesion on one side of the prostate are eligible. They must have good sexual function (SHIM score ≥17) before surgery and be treated by participating doctors at Henry Ford Health.

Inclusion Criteria

My cancer does not have a high Gleason score on the opposite side.

I am a prostate cancer patient at Henry Ford Health choosing surgery, treated by the study's doctors.

My prostate cancer has a Gleason score of 7 or less.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Participants undergo either Radical Prostatectomy or Precision Prostatectomy

1 day

1 visit (in-person)

Post-Surgery Recovery

Participants recover from surgery and initial outcomes are monitored

3 months

1 visit (in-person), 1 visit (virtual)

Follow-up

Participants are monitored for functional and oncological outcomes

12 months

2 visits (in-person), 1 visit (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Precision Prostatectomy
• Radical Prostatectomy

Trial Overview

The trial compares traditional radical prostatectomy (RP) with precision prostatectomy (PP), which aims to preserve more nerve and tissue structures for better functional outcomes. The study will assess if PP can match RP's cancer control while improving recovery of sexual potency and continence.

How Is the Trial Designed?

Group I: Precision Prostatectomy Experimental Treatment 1 Intervention

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

Group II: Radical Prostatectomy Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Henry Ford Health System

Lead Sponsor

Trials

334

Recruited

2,197,000+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38985306/

Outcomes after precision prostatectomy: safety, efficacy ...

PP is a safe and reproducible technique that can ensure cancer control and preservation of functional status in select patients.

2.

reports.mountsinai.org

reports.mountsinai.org/article/uro2025-new-study-shows-promising-results-for-precision-prostatectomy

New Study Shows Promising Results for Precision ...

A new Mount Sinai study confirms that a novel approach to prostatectomy is safe and effective in achieving both aims among patients with prostate cancer.

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07348367?aggFilters=status%3Arec

A Comparison of Radical Prostatectomy and Precision ...

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

4.

nejm.org

nejm.org/doi/full/10.1056/NEJMoa2214122

Fifteen-Year Outcomes after Monitoring, Surgery, or ...

After median follow-up of 15 years, 45 patients (2.7%) had died of prostate cancer: 17 (3.1%) in the active-monitoring group, 12 (2.2%) in the ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9260793/

Impact of prostate biopsy technique on outcomes of the ...

Notably, by 12 months postoperatively, 90% of preoperatively potent men reported a return of erections sufficient for intercourse. Furthermore, ...

6.

auajournals.org

auajournals.org/doi/10.1097/JU.0000000000003328.03

V10-03 OUTCOMES OF PRECISION PROSTATECTOMY ...

At 36 months, 93% of patients were free from clinically significant residual PCa, 91% had not undergone additional treatment, and 100% were ...

7.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0302283821021187

Description of Surgical Technique and Oncologic ...

Conclusions. Precision prostatectomy is technically safe and reproducible and offers excellent postoperative functional results. At 36-mo follow-up, the ...