A Prospective Trial on Nerve Sparing Techniques Performed in Radical Prostatectomy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Prostate Cancer
- Sponsor
- Weill Medical College of Cornell University
- Enrollment
- 3
- Locations
- 1
- Primary Endpoint
- Number of Treatment-Related Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
- Status
- Terminated
- Last Updated
- 4 years ago
Overview
Brief Summary
The investigators propose a prospective study to assess recovery of urinary and sexual function by nerve sparing techniques after radical prostatectomy.
Detailed 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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Number of Treatment-Related Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Time Frame: Up to 24 months following surgery
The investigators will obtain patient-reported complications and adverse events captured from patient's medical record.
Change in Patient-reported Health-Related Quality of Life (HRQOL) Scores as Assessed by Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP)
Time Frame: Baseline, 1 month, 6 months, 12 months, and 24 months post-surgery
Patients will fill out the EPIC-CP questionnaire. The EPIC-CP is a 10-item questionnaire assessing five health-related quality of life domains: urinary function, urinary irritation, bowel function, sexual function, and hormonal issues. All questions are about patients' health and symptoms in the last four weeks. Each domain is scored out of 12 points, with higher scores indicating more complications. In total, the EPIC-CP score is the final sum of the 5 domains. The EPIC-CP is scored out of 60 points, with higher scores indicating more issues related to overall prostate cancer quality of life.
Change from Baseline in Prostate Specific Antigen (PSA) value on Laboratory Reports up to 24 Months Following Surgery
Time Frame: Baseline and up to 24 months post-surgery
The investigators will obtain patient's PSA values from their medical record, at baseline and up to 24 months post-surgery. Patient PSA levels are obtained from standard of care blood tests, and PSA values are measured in ng/mL.
Secondary Outcomes
- Change in Baseline in Patient-Reported Penile Deformity as Assessed on Questionnaire(Baseline, 6 months, 12 months, and 24 months post-surgery)
- Change in Patient-reported Treatment Regret Scores as Assessed by Questionnaire(12 months, 24 months post-surgery)
- Change in Baseline in Patient-Reported Penile Shortening as Assessed on Questionnaire(Baseline, 1 month, 6 months, 12 months, and 24 months post-surgery)