Prostate CancerNCT04393831
A Prospective Trial on Nerve Sparing Techniques Performed in Radical Prostatectomy
A study testing Retzius sparing in people with Prostate Cancer and Quality of Life, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
The investigators propose a prospective study to assess recovery of urinary and sexual function by nerve sparing techniques after radical prostatectomy. Read more about this study
- Who is it for?
- Ages 40 to 80 years, men only
- Conditions the study is for
- Prostate Cancer, Quality of Life
- What is being tested?
- Retzius sparing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2021to 15 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
The investigators propose a prospective study to assess recovery of urinary and sexual function by nerve sparing techniques after radical prostatectomy.
Read the 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.
- Conditions
- Prostate Cancer, Quality of Life
- Being tested
- Retzius sparing
- Keywords
- prostate cancer, radical prostatectomy, robot-assisted radical prostatectomy, prostatectomy, nerve sparing, Retzius, quality of life, urinary incontinence, sexual function
- Medical subject headings
- Prostatic Neoplasms, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retzius sparingProcedure or surgery
Retzius nerve sparing is a specific approach that avoids disrupting the structures involved in urinary and sexual function.
| Study group | Role | What they receive |
|---|---|---|
| Retzius sparing | Active comparator | 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. Receives: Procedure: Retzius sparing |
| Conventional (non-Retzius) nerve sparing | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Treatment-Related Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
The investigators will obtain patient-reported complications and adverse events captured from patient's medical record.
Measured: Up to 24 months following surgery
Change in Patient-reported Health-Related Quality of Life (HRQOL) Scores as Assessed by Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP)
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.
Measured: Baseline, 1 month, 6 months, 12 months, and 24 months post-surgery
Change from Baseline in Prostate Specific Antigen (PSA) value on Laboratory Reports up to 24 Months Following 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.
Measured: Baseline and up to 24 months post-surgery
Secondary outcomes (3)
Change in Baseline in Patient-Reported Penile Shortening as Assessed on Questionnaire
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.
Measured: Baseline, 1 month, 6 months, 12 months, and 24 months post-surgery
Change in Baseline in Patient-Reported Penile Deformity as Assessed on Questionnaire
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.
Measured: Baseline, 6 months, 12 months, and 24 months post-surgery
Change in Patient-reported Treatment Regret Scores as Assessed by Questionnaire
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.
Measured: 12 months, 24 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2020
- Study start15 Jun 2021
- Primary completion15 Sep 2021
- Study completion15 Sep 2021
Why it stopped: This study was terminated to facilitate accrual under NCT05155501
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial comparing Retzius sparing robot-assisted radical prostatectomy versus conventional robot-assisted radical prostatectomy
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jim C Hu, MD MPH, Principal investigator, Weill Cornell Medicine, NewYork-Presbyterian
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04393831
- Sponsor's protocol ID
- 1512016820
- Status last verified
- Feb 2022
- First submitted
- 14 May 2020
- Last updated
- 11 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Trial on Nerve Sparing Techniques Performed in Radical Prostatectomy
- ClinicalTrials.gov ID
- NCT04393831
- Acronym / sponsor ID
- 1512016820
- Conditions
- Prostate Cancer, Quality of Life
- Keywords
- prostate cancer, radical prostatectomy, robot-assisted radical prostatectomy, prostatectomy, nerve sparing, Retzius, quality of life, urinary incontinence
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This study was terminated to facilitate accrual under NCT05155501
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- 15 Jun 2021 (actual)
- Primary completion
- 15 Sep 2021 (actual)
- Study completion
- 15 Sep 2021 (actual)
- First posted
- 19 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial comparing Retzius sparing robot-assisted radical prostatectomy versus conventional robot-assisted radical prostatectomy
| Arm | Type | Receives |
|---|---|---|
| Retzius sparing | Active comparator | Procedure: Retzius sparingUsing 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. |
| Conventional (non-Retzius) nerve sparing | No intervention | –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. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Retzius sparingRetzius nerve sparing is a specific approach that avoids disrupting the structures involved in urinary and sexual function. | Procedure or surgery | Retzius sparing |
Primary outcome
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.
3 secondary outcomes
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
Change in Baseline in Patient-Reported Penile Deformity as Assessed on Questionnaire
Time frame: Baseline, 6 months, 12 months, and 24 months post-surgery
Change in Patient-reported Treatment Regret Scores as Assessed by Questionnaire
Time frame: 12 months, 24 months post-surgery
Results and safety
The study was stopped early (reason given: This study was terminated to facilitate accrual under NCT05155501). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2022.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jim C Hu, MD MPH principal investigator
Weill Cornell Medicine, NewYork-Presbyterian
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Retzius sparing in people with Prostate Cancer and Quality of Life, run by Weill Medical College of Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: This study was terminated to facilitate accrual under NCT05155501). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2022.