A Prospective Trial on Nerve Sparing Techniques Performed in Radical Prostatectomy

Weill Cornell Medicine (WCM)

Status: Terminated

Conditions: Quality of Life; Prostate Cancer

Treatments: Procedure: Retzius sparing

Study type: Interventional

Funder types: Other

Identifiers

NCT04393831

1512016820

Details and patient eligibility

About

The investigators propose a prospective study to assess recovery of urinary and sexual function by nerve sparing techniques after radical prostatectomy.

Full description

Subjects will be randomized in a 1:1 ratio to Retzius nerve sparing versus non-Retzius nerve sparing to compare cancer outcomes and urinary/sexual outcomes following radical prostatectomy. Using the Retzius technique, the surgeon will remove the prostate in a way that preserves a portion of the nerves and tissue structures that are typically removed during the conventional technique.

The investigators will assess recovery of urinary and sexual function of patients through questionnaires at 1 week, 1 month, 6 months, 12 months, and 24 months after surgery.

Enrollment: 3 patients

Sex: Male

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• clinically localized prostate cancer
• able to read and speak English or Spanish
• no previous history of head injury, dementia or psychiatric illness
• no other concurrent cancer
• estimated life expectancy of 10 years or more
• biopsy proven prostate cancer

Exclusion criteria

• evidence of metastases
• Prostate specific antigen (PSA) greater than 30 ng/mL
• previous major pelvic surgery
• diagnosis of another malignancy within the past 5 years, with the exception of non-melanoma skin cancer

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

3 participants in 2 patient groups

Retzius sparing

Active Comparator group

Description:

Using the Retzius technique, the surgeon will remove the prostate in a way that preserves a portion of the nerves and tissue structures that are typically removed during the conventional technique.

Treatment:

Procedure: Retzius sparing

Conventional (non-Retzius) nerve sparing

No Intervention group

Description:

A non-Retzius nerve sparing technique will be performed, according to surgeon's preference--nerve sparing during radical prostatectomy is performed with significant variation and there is an absence of universally agreed upon steps or techniques.