- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04393831
A Prospective Trial on Nerve Sparing Techniques Performed in Radical Prostatectomy
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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New York
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New York, New York, United States, 10065
- Weill Cornell Medicine
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Retzius sparing
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.
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Retzius nerve sparing is a specific approach that avoids disrupting the structures involved in urinary and sexual function.
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No Intervention: Conventional (non-Retzius) nerve sparing
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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The investigators will obtain patient-reported complications and adverse events captured from patient's medical record.
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Up to 24 months following surgery
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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. |
Baseline, 1 month, 6 months, 12 months, and 24 months post-surgery
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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
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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.
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Baseline and up to 24 months post-surgery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Baseline in Patient-Reported Penile Shortening as Assessed on Questionnaire
Time Frame: Baseline, 1 month, 6 months, 12 months, and 24 months post-surgery
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Patients will fill out a validated, 5-item questionnaire assessing penile shortening, self-esteem, and presence of erections. Question 1 assesses patients' perceived penile length post-surgery, compared to penile length at 30 years of age. It consists of two possible responses: Yes or No. Questions 2 and 3 assesses patients' ability to obtain and quality of spontaneous morning erections and sexual activity-related erections. It consists of five possible responses: ranging from "No erections" to "Erections always sufficient". Question 4 is a visual digital scale assessing patients' present quality of life. It is scored on a scale of 1-7, with higher scores indicating high quality of life. Question 5 is a visual digital scale assessing patients' present self-esteem. It is scored on a scale of 1-7, with higher scores indicating high self-esteem. |
Baseline, 1 month, 6 months, 12 months, and 24 months post-surgery
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Change in Baseline in Patient-Reported Penile Deformity as Assessed on Questionnaire
Time Frame: Baseline, 6 months, 12 months, and 24 months post-surgery
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Patients will fill out a validated, 3-item questionnaire assessing presence of Peyronie's disease. Question 1 assesses penile hardening in the flaccid state. Question 2 assesses penile curvature in the erect state. Question 3 assesses pain associated with erection. Each question consists of two possible responses: Yes or No. |
Baseline, 6 months, 12 months, and 24 months post-surgery
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Change in Patient-reported Treatment Regret Scores as Assessed by Questionnaire
Time Frame: 12 months, 24 months post-surgery
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Patients will fill out a validated, 5-item questionnaire assessing feelings toward treatment regret. Each item is scored on a 5 point scale ranging from "Strongly Agree" to "Strongly Disagree". Responses are converted to a score ranging from 0-100, with higher scores indicating more regret. |
12 months, 24 months post-surgery
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Collaborators and Investigators
Investigators
- Principal Investigator: Jim C Hu, MD MPH, Weill Cornell Medicine, NewYork-Presbyterian
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1512016820
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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