Erectile Dysfunction Following Radical ProstatectomyPhase 4NCT01770340
Nerve Grafting With an Allograft During Radical Prostatectomy - Extended Follow-up in a Prospective Randomized Trial
A Phase 4 study testing Radical prostatectomy with implantation of allograft and Radical prostatectomy without implantation of allograft in people with Erectile Dysfunction Following Radical Prostatectomy, run by Kantonsspital Winterthur KSW at 1 site in Switzerland.
Trial summary
Earlier studies were able to show that an improvement of the erectile function following a non-nerve sparing radical prostatectomy could be achieved using an autologous nerve graft. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Erectile Dysfunction Following Radical Prostatectomy
- What is being tested?
- Radical prostatectomy with implantation of allograft and Radical prostatectomy without implantation of allograft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2011to 1 Jul 2020
- Phase
- Phase 4
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Localized intermediate-risk or high-risk prostate cancer cT3
- Gleason score ≥ 7 (3+4 and/or 4+3) and/or
- PSA ≥ 20 ng/ml
- intact preoperative erectile function with an IIEF ≥ 21 (IIEF-6).
Who cannot join
- IIEF < 21
- Operations in the past 6 months which could limit the erectile function
- Erectile dysfunction in the history or current medication for erectile dysfunction
- Current involvement in another comparable study.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Kantonsspital Winterthur
Winterthur, Canton of Zurich, 8401
About this study
Earlier studies were able to show that an improvement of the erectile function following a non-nerve sparing radical prostatectomy could be achieved using an autologous nerve graft.
The investigators evaluate the use of the implantation of the allogenic nerve graft Avance® in patients undergoing non nerve-sparing radical prostatectomy.
Read the detailed description
In this prospective randomised and single-blind, clinical phase-IV study, 60 patients are randomized into the treatment group and the control group. The follow-up is at least 24 months.
The inclusion criteria were localized prostate cancers cT3 and/or Gleason score ≥ 7 (a or b) and/or prostate-specific antigen (PSA) ≥ 20 ng/ml and furthermore an erectile function with an IIEF ≥ 21 (IIEF-6).
The operation carried out is a standardised, robot assisted laparoscopic radical prostatectomy with total excision of both neurovascular bundles.
The Outcome measurement is done with the "quality of life questionnaire before and after prostate surgery" that includes the "International Index of Erectile Function" (IIEF) questionnaire.
The limitations are a small cohort, a short observation period and the lack of statistical analysis due to a still low number of patients.
- Being tested
- Radical prostatectomy with implantation of allograft, Radical prostatectomy without implantation of allograft
- Keywords
- radical prostatectomy, erectile function, nerve grafting, allogenic, prostate cancer, Allogenic nerve graft, Time required for nerve grafting
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radical prostatectomy with implantation of allograftBiological
Interposition of resected neurovascular bundles with allograft Avance®
Radical prostatectomy without implantation of allograftProcedure or surgery
No interposition of resected neurvascular bundles
| Study group | Role | What they receive |
|---|---|---|
| Control group | Sham comparator | Radical prostatectomy without implantation of allograft Receives: Procedure: Radical prostatectomy without implantation of allograft |
| Treatment group | Experimental | Radical prostatectomy with implantation of allograft Receives: Biological: Radical prostatectomy with implantation of allograft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Erectile function score (IIEF: international index of erectile function) after non nerve sparing radical prostatectomy
Erectile function score (IIEF: international index of erectile function) after non nerve sparing radical prostatectomy. To show a complete impotence in the control group and an enhancement of the initial postoperative impotence in the treatment group
Measured: 24 months
Secondary outcomes (1)
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Monitoring of side effects and complications in connection with the nerve-implantation.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2013 (estimated)
- Study startJan 2011
- Primary completionApr 2017
- Study completion1 Jul 2020
Why it stopped: Poor recruitment, Interim analysis: The rates of pts who reached primary and secondary endpoints were lower than expected.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile Dysfunction Following Radical ProstatectomyStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kantonsspital Winterthur KSW
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hubert John, Chefarzt, Principal investigator, Kantonsspital Winterthur KSW
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01770340
- Sponsor's protocol ID
- KEK-ZH-NR:2010-0004/0
- Status last verified
- Feb 2021
- First submitted
- 13 Dec 2012
- Last updated
- 21 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nerve Grafting With an Allograft During Radical Prostatectomy - Extended Follow-up in a Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT01770340
- Acronym / sponsor ID
- KEK-ZH-NR:2010-0004/0
- Keywords
- radical prostatectomy, erectile function, nerve grafting, allogenic, prostate cancer, Allogenic nerve graft, Time required for nerve grafting
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor recruitment, Interim analysis: The rates of pts who reached primary and secondary endpoints were lower than expected.
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Kantonsspital Winterthur KSWUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Apr 2017 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 17 Jan 2013 (estimated)
- 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.
Earlier studies were able to show that an improvement of the erectile function following a non-nerve sparing radical prostatectomy could be achieved using an autologous nerve graft.
The investigators evaluate the use of the implantation of the allogenic nerve graft Avance® in patients undergoing non nerve-sparing radical prostatectomy.
Detailed description
In this prospective randomised and single-blind, clinical phase-IV study, 60 patients are randomized into the treatment group and the control group. The follow-up is at least 24 months.
The inclusion criteria were localized prostate cancers cT3 and/or Gleason score ≥ 7 (a or b) and/or prostate-specific antigen (PSA) ≥ 20 ng/ml and furthermore an erectile function with an IIEF ≥ 21 (IIEF-6).
The operation carried out is a standardised, robot assisted laparoscopic radical prostatectomy with total excision of both neurovascular bundles.
The Outcome measurement is done with the "quality of life questionnaire before and after prostate surgery" that includes the "International Index of Erectile Function" (IIEF) questionnaire.
The limitations are a small cohort, a short observation period and the lack of statistical analysis due to a still low number of patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Sham comparator | Procedure: Radical prostatectomy without implantation of allograftRadical prostatectomy without implantation of allograft |
| Treatment group | Experimental | Biological: Radical prostatectomy with implantation of allograftRadical prostatectomy with implantation of allograft |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Localized intermediate-risk or high-risk prostate cancer cT3
- Gleason score ≥ 7 (3+4 and/or 4+3) and/or
- PSA ≥ 20 ng/ml
- intact preoperative erectile function with an IIEF ≥ 21 (IIEF-6).
Key exclusion criteria (4 listed)
- IIEF < 21
- Operations in the past 6 months which could limit the erectile function
- Erectile dysfunction in the history or current medication for erectile dysfunction
- Current involvement in another comparable study.
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 |
|---|---|---|
| Radical prostatectomy with implantation of allograftInterposition of resected neurovascular bundles with allograft Avance® | Biological | Treatment group |
| Radical prostatectomy without implantation of allograftNo interposition of resected neurvascular bundles | Procedure or surgery | Control group |
Primary outcome
Erectile function score (IIEF: international index of erectile function) after non nerve sparing radical prostatectomy
Time frame: 24 months
Erectile function score (IIEF: international index of erectile function) after non nerve sparing radical prostatectomy. To show a complete impotence in the control group and an enhancement of the initial postoperative impotence in the treatment group
1 secondary outcome
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: 24 months
Results and safety
The study was stopped early (reason given: Poor recruitment, Interim analysis: The rates of pts who reached primary and secondary endpoints were lower than expected.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2021.
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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.
Hubert John, Chefarzt principal investigator
Kantonsspital Winterthur KSW
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Radical prostatectomy with implantation of allograft and Radical prostatectomy without implantation of allograft in people with Erectile Dysfunction Following Radical Prostatectomy, run by Kantonsspital Winterthur KSW at 1 site in Switzerland.
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 4 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 21 Feb 2021. 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 Switzerland. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Poor recruitment, Interim analysis: The rates of pts who reached primary and secondary endpoints were lower than expected.). 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?
Erectile function score (IIEF: international index of erectile function) after non nerve sparing radical prostatectomy (time frame: 24 months). 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 21 Feb 2021.