Prostate CancerNCT00928850
Modifications to Radical Prostatectomy: Feasibility Study
A study testing radical prostatectomy with urethral irrigation but no fascial suturing, QOL forms, radical prostatectomy with fascial suturing but no urethral irrigation, QOL forms and radical prostatectomy with both urethral irrigation and fascial suturing, QOL forms in people with Prostate Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
This study aims to determine whether surgeons at Memorial Sloan-Kettering Cancer Center are able to randomize patients to test modifications of surgery to remove the prostate. Surgery to remove the prostate is known as a "radical prostatectomy". Read more about this study
- Who is it for?
- Ages 21 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- radical prostatectomy with urethral irrigation but no fascial suturing, QOL forms, radical prostatectomy with fascial suturing but no urethral irrigation, QOL forms and radical prostatectomy with both urethral irrigation and fascial suturing, QOL forms
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to 4 May 2018
- 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 21 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for radical prostatectomy for the treatment of prostate cancer with one of the consenting surgeons at MSKCC.
Who cannot join
- Prior treatment for prostate cancer: radiation, hormonal therapy, chemotherapy or focal therapy.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: A Randomized Trial of Modifications to Radical Prostatectomy: Feasibility Study
This study aims to determine whether surgeons at Memorial Sloan-Kettering Cancer Center are able to randomize patients to test modifications of surgery to remove the prostate. Surgery to remove the prostate is known as a "radical prostatectomy". Surgeons know many things about the best way to do a radical prostatectomy. However, there is disagreement about some aspects of surgery. Two modifications of surgery to remove the prostate (radical prostatectomy) identified for this study include Irrigation, and Fascial Suturing.
Two aspects of the operation may vary, fascial suturing and urethral irrigation. For each aspect, surgeons will use their clinical judgment as to the best interests of the patient. In other words, if there are clear reasons to use or avoid a fascial suturing approach, the surgeon will act accordingly; similarly, if there is a clear reason to irrigate or avoid irrigating the urethra, the surgeon can make the appropriate clinical decision. If the surgeon is unsure as to which approach to take, then the randomization scheme will be followed.
Read more
All of the surgeons who are taking part in this study have used these techniques at different times. However, they are unsure as to the best approach. Sometimes, they use different treatments with different patients.
Irrigation. Cancer cells can spill during surgery and this can cause cancer to return ("recur"). Some surgeons believe that "irrigating" could help stop spilling of cancer cells. "Irrigating" means washing the surgical area with sterile water and sucking the water back up through a tube. As a result, surgeons vary as to how they irrigate. In this study, we will examine irrigation of the urethra. This is the part of the body that carries urine from the bladder to the penis.
Fascial suturing. Surgeons believe that what happens to the urethra can affect the risk of incontinence. This is when a patient cannot control urine, and drips or leaks urine. One idea is that additional stitches ("sutures") to the connective tissue ("fascia") could be helpful, but this is not known for sure.
- Conditions
- Prostate Cancer
- Being tested
- radical prostatectomy with urethral irrigation but no fascial suturing, QOL forms, radical prostatectomy with fascial suturing but no urethral irrigation, QOL forms, radical prostatectomy with both urethral irrigation and fascial suturing, QOL forms, radical prostatectomy with neither urethral irrigation nor fascial suturing, QOL forms
- Keywords
- Prostate, Radical Prostatectomy, urethral irrigation, fascial suturing, 09-051
- 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 urethral irrigation but no fascial suturing, QOL formsProcedure or surgery
Cancer cells can spill during surgery and this can cause cancer to return ("recur"). Some surgeons believe that "irrigating" could help stop spilling of cancer cells. "Irrigating" means washing the surgical area with sterile water and sucking the water back up through a tube. As a result, surgeons vary as to how they irrigate. In this study, we will examine irrigation of the urethra. This is the part of the body that carries urine from the bladder to the penis. Quality of life are assessed for clinical evaluation approximately 3, 6, 9, 12, 18, 24, 36 and 48 months after surgery
radical prostatectomy with fascial suturing but no urethral irrigation, QOL formsProcedure or surgery
Surgeons believe that what happens to the urethra can affect the risk of incontinence. This is when a patient cannot control urine, and drips or leaks urine. One idea is that additional stitches ("sutures") to the connective tissue ("fascia") could be helpful, but this is not known for sure. Quality of life are assessed for clinical evaluation approximately 3, 6, 9, 12, 18, 24, 36 and 48 months after surgery
radical prostatectomy with both urethral irrigation and fascial suturing, QOL formsProcedure or surgery
Quality of life are assessed for clinical evaluation approximately 3, 6, 9, 12, 18, 24, 36 and 48 months after surgery
radical prostatectomy with neither urethral irrigation nor fascial suturing, QOL formsProcedure or surgery
Quality of life are assessed for clinical evaluation approximately 3, 6, 9, 12, 18, 24, 36 and 48 months after surgery
| Study group | Role | What they receive |
|---|---|---|
| urethral irrigation but no fascial suturing, QOL forms | Active comparator | The anterior two-thirds of the urethra is divided exposing a Foley catheter that was placed at the beginning of the procedure. Irrigation of the urethra may prevent spread of prostate cancer cells to tissue that is not removed during surgery. The urethra is irrigated with 60 cc of sterile water as it is withdrawn from the patient to 'wash' the urethra. Receives: Procedure: radical prostatectomy with urethral irrigation but no fascial suturing, QOL forms |
| fascial suturing but no urethral irrigation, QOL forms | Active comparator | For patients undergoing fascial suturing only, after the initial placement of the suture through the urethra a second bite is taken deeply into the fascia of the lateral pelvic fascia. Receives: Procedure: radical prostatectomy with fascial suturing but no urethral irrigation, QOL forms |
| both urethral irrigation and fascial suturing, QOL forms | Active comparator | Not described Receives: Procedure: radical prostatectomy with both urethral irrigation and fascial suturing, QOL forms |
| neither urethral irrigation nor fascial suturing, QOL forms | Active comparator | Not described Receives: Procedure: radical prostatectomy with neither urethral irrigation nor fascial suturing, QOL forms |
What is being measured
The primary outcome is the main question the study is designed to answer.
To pilot a randomized trial of modifications to radical prostatectomy to determine:Proportion of patients accrued and Accrual rate
Measured: 1 year
Secondary outcomes (1)
Determine surgeon compliance with allocation
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2009 (estimated)
- Study startJun 2009
- Primary completion4 May 2018
- Study completion4 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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
- Masking
- None (open label)
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew Vickers, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00928850
- Sponsor's protocol ID
- 09-051
- Status last verified
- Nov 2019
- First submitted
- 25 Jun 2009
- Last updated
- 21 Nov 2019
- Results posted
- No
Publications
Vickers AJ, Bennette C, Touijer K, Coleman J, Laudone V, Carver B, Eastham JA, Scardino PT. Feasibility study of a clinically-integrated randomized trial of modifications to radical prostatectomy. Trials. 2012 Feb 24;13:23. doi: 10.1186/1745-6215-13-23.
PubMed 22364367
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Modifications to Radical Prostatectomy: Feasibility Study
- ClinicalTrials.gov ID
- NCT00928850
- Acronym / sponsor ID
- 09-051
- Conditions
- Prostate Cancer
- Keywords
- Prostate, Radical Prostatectomy, urethral irrigation, fascial suturing, 09-051
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- 4 May 2018 (actual)
- Study completion
- 4 May 2018 (actual)
- First posted
- 26 Jun 2009 (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.
This study aims to determine whether surgeons at Memorial Sloan-Kettering Cancer Center are able to randomize patients to test modifications of surgery to remove the prostate. Surgery to remove the prostate is known as a "radical prostatectomy". Surgeons know many things about the best way to do a radical prostatectomy. However, there is disagreement about some aspects of surgery. Two modifications of surgery to remove the prostate (radical prostatectomy) identified for this study include Irrigation, and Fascial Suturing.
Two aspects of the operation may vary, fascial suturing and urethral irrigation. For each aspect, surgeons will use their clinical judgment as to the best interests of the patient. In other words, if there are clear reasons to use or avoid a fascial suturing approach, the surgeon will act accordingly; similarly, if there is a clear reason to irrigate or avoid irrigating the urethra, the surgeon can make the appropriate clinical decision. If the surgeon is unsure as to which approach to take, then the randomization scheme will be followed.
All of the surgeons who are taking part in this study have used these techniques at different times. However, they are unsure as to the best approach. Sometimes, they use different treatments with different patients.
Irrigation. Cancer cells can spill during surgery and this can cause cancer to return ("recur"). Some surgeons believe that "irrigating" could help stop spilling of cancer cells. "Irrigating" means washing the surgical area with sterile water and sucking the water back up through a tube. As a result, surgeons vary as to how they irrigate. In this study, we will examine irrigation of the urethra. This is the part of the body that carries urine from the bladder to the penis.
Fascial suturing. Surgeons believe that what happens to the urethra can affect the risk of incontinence. This is when a patient cannot control urine, and drips or leaks urine. One idea is that additional stitches ("sutures") to the connective tissue ("fascia") could be helpful, but this is not known for sure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| urethral irrigation but no fascial suturing, QOL forms | Active comparator | Procedure: radical prostatectomy with urethral irrigation but no fascial suturing, QOL formsThe anterior two-thirds of the urethra is divided exposing a Foley catheter that was placed at the beginning of the procedure. Irrigation of the urethra may prevent spread of prostate cancer cells to tissue that is not removed during surgery. The urethra is irrigated with 60 cc of sterile water as it is withdrawn from the patient to 'wash' the urethra. |
| fascial suturing but no urethral irrigation, QOL forms | Active comparator | Procedure: radical prostatectomy with fascial suturing but no urethral irrigation, QOL formsFor patients undergoing fascial suturing only, after the initial placement of the suture through the urethra a second bite is taken deeply into the fascia of the lateral pelvic fascia. |
| both urethral irrigation and fascial suturing, QOL forms | Active comparator | Procedure: radical prostatectomy with both urethral irrigation and fascial suturing, QOL forms |
| neither urethral irrigation nor fascial suturing, QOL forms | Active comparator | Procedure: radical prostatectomy with neither urethral irrigation nor fascial suturing, QOL forms |
Who may qualify
- Ages
- 21 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients scheduled for radical prostatectomy for the treatment of prostate cancer with one of the consenting surgeons at MSKCC.
Key exclusion criteria (1 listed)
- Prior treatment for prostate cancer: radiation, hormonal therapy, chemotherapy or focal therapy.
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 urethral irrigation but no fascial suturing, QOL formsCancer cells can spill during surgery and this can cause cancer to return ("recur"). Some surgeons believe that "irrigating" could help stop spilling of cancer cells. "Irrigating" means washing the surgical area with sterile water and sucking the water back up through a tube. As a result, surgeons vary as to how they irrigate. In this study, we will examine irrigation of the urethra. This is the part of the body that carries urine from the bladder to the penis. Quality of life are assessed for clinical evaluation approximately 3, 6, 9, 12, 18, 24, 36 and 48 months after surgery | Procedure or surgery | urethral irrigation but no fascial suturing, QOL forms |
| radical prostatectomy with fascial suturing but no urethral irrigation, QOL formsSurgeons believe that what happens to the urethra can affect the risk of incontinence. This is when a patient cannot control urine, and drips or leaks urine. One idea is that additional stitches ("sutures") to the connective tissue ("fascia") could be helpful, but this is not known for sure. Quality of life are assessed for clinical evaluation approximately 3, 6, 9, 12, 18, 24, 36 and 48 months after surgery | Procedure or surgery | fascial suturing but no urethral irrigation, QOL forms |
| radical prostatectomy with both urethral irrigation and fascial suturing, QOL formsQuality of life are assessed for clinical evaluation approximately 3, 6, 9, 12, 18, 24, 36 and 48 months after surgery | Procedure or surgery | both urethral irrigation and fascial suturing, QOL forms |
| radical prostatectomy with neither urethral irrigation nor fascial suturing, QOL formsQuality of life are assessed for clinical evaluation approximately 3, 6, 9, 12, 18, 24, 36 and 48 months after surgery | Procedure or surgery | neither urethral irrigation nor fascial suturing, QOL forms |
Primary outcome
To pilot a randomized trial of modifications to radical prostatectomy to determine:Proportion of patients accrued and Accrual rate
Time frame: 1 year
1 secondary outcome
Determine surgeon compliance with allocation
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2019.
- Derived from this study: PubMed 22364367Vickers AJ, Bennette C, Touijer K, Coleman J, Laudone V, Carver B, Eastham JA, Scardino PT. Feasibility study of a clinically-integrated randomized trial of modifications to radical prostatectomy. Trials. 2012 Feb 24;13:23. doi: 10.1186/1745-6215-13-23.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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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.
Andrew Vickers, MD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing radical prostatectomy with urethral irrigation but no fascial suturing, QOL forms, radical prostatectomy with fascial suturing but no urethral irrigation, QOL forms and radical prostatectomy with both urethral irrigation and fascial suturing, QOL forms in people with Prostate Cancer, run by Memorial Sloan Kettering Cancer Center 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 21 Nov 2019. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To pilot a randomized trial of modifications to radical prostatectomy to determine:Proportion of patients accrued and Accrual rate (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00928850, which also lists 1 linked publication.
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 Nov 2019.