Comparison of radical prostatectomy and precision prostatectomy for men with low- or intermediate-risk prostate cancer
A Randomized Comparison of Radical Prostatectomy and Precision Prostatectomy in Low- and Intermediate-risk Prostate Cancers.
NA · Henry Ford Health System · NCT07348367
This trial tests whether precision prostatectomy preserves sexual function and bladder control better than radical prostatectomy for men with low- or intermediate-risk prostate cancer.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Sex | Male |
| Sponsor | Henry Ford Health System (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (Detroit, Michigan) |
| Trial ID | NCT07348367 on ClinicalTrials.gov |
What this trial studies
Eligible men will undergo either standard radical prostatectomy or precision prostatectomy at Henry Ford Health and be followed for postoperative functional and oncologic outcomes. Precision prostatectomy aims to remove >90% of prostate tissue while preserving the capsule, seminal vesicle, and contralateral nNOS-containing nerves to improve potency and continence. Primary outcomes include sexual potency (SHIM score ≥17) and urinary continence (0–1 pads/day), with PSA-based oncologic control monitored over at least 12 months. Enrollment is limited to patients with unilateral dominant disease, Gleason ≤4+3 on biopsy, PSA ≤20 ng/mL, clinical stage ≤cT2, and preoperative SHIM ≥17.
Who should consider this trial
Good fit: Ideal candidates are men with low- or intermediate-risk, unilateral prostate cancer (PSA ≤20, clinical stage ≤cT2, dominant lesion Gleason ≤4+3) who have preoperative SHIM ≥17 and are treated at Henry Ford Health.
Not a fit: Men with high-risk, bilateral, nodal, or metastatic disease, prior prostate cancer therapy, recent androgen deprivation use, prior cancers, or significant comorbidities with life expectancy under five years are unlikely to receive benefit.
Why it matters
Potential benefit: If successful, precision prostatectomy could let many men keep sexual function and urinary control while maintaining acceptable cancer control.
How similar studies have performed: Early reports of precision prostatectomy have shown promising functional outcomes (about 90% potency and 100% continence at 12 months), but long-term oncologic data are limited.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Detroit, Michigan
- Henry Ford Health — Detroit, Michigan, United States (RECRUITING)
Study contacts
- Study coordinator: Firas Abdollah, MD, FEBU
- Email: fabdoll1@hfhs.org
- Phone: 313-673-7463
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Prostatectomy, Prostate Cancer