Prostatic NeoplasmsPhase 4NCT01365143
Prospective Randomized Trial Comparing Robotic Versus Open Radical Prostatectomy
A Phase 4 study testing Robotic Radical Prostatectomy and Open Radical Prostatectomy in people with Prostatic Neoplasms and Adenocarcinoma, run by Mayo Clinic at 1 site in United States.
Trial summary
To date, no study has prospectively compared open versus robotic radical prostatectomy in a randomized fashion for patients with prostate cancer. For patients with newly diagnosed prostate cancer who choose surgical management, the choice of surgical approach is often limited to surgeon preference and experience. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostatic Neoplasms, Adenocarcinoma
- What is being tested?
- Robotic Radical Prostatectomy and Open Radical Prostatectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to Feb 2014
- 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
- Biopsy proven adenocarcinoma of the prostate
- Deemed a surgical candidate for a bilateral nerve bundle preservation
- Potent
- Continent of urine
- Surgical candidate for both open and robotic nerve-sparing radical prostatectomy
- Age >18
Who cannot join
- Previous treatment of prostate cancer (radiation, hormones, etc.)
Trial locations and contacts
1 site in 1 country.
About this study
To date, no study has prospectively compared open versus robotic radical prostatectomy in a randomized fashion for patients with prostate cancer. For patients with newly diagnosed prostate cancer who choose surgical management, the choice of surgical approach is often limited to surgeon preference and experience. This study will prospectively randomize patients with localized prostate cancer who are candidates for surgical management to open versus robotic radical prostatectomy.
- Conditions
- Prostatic Neoplasms, Adenocarcinoma
- Being tested
- Robotic Radical Prostatectomy, Open Radical Prostatectomy
- Medical subject headings
- Prostatic Neoplasms, Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic Radical ProstatectomyProcedure or surgery
Robotic assisted radical prostatectomy
Open Radical ProstatectomyProcedure or surgery
Open radical prostatectomy
| Study group | Role | What they receive |
|---|---|---|
| Open Radical Prostatectomy | Active comparator | Not described Receives: Procedure: Open Radical Prostatectomy |
| Robotic radical prostatectomy | Active comparator | Not described Receives: Procedure: Robotic Radical Prostatectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trifecta
Free from biochemical recurrence, continent, and potent 2 years after radical prostatectomy
Measured: at 2 years
Secondary outcomes (8)
Continence
Continent of urine
Measured: at 3, 12, and 24 months
Potency
Satisfactory erections
Measured: at 3, 12, and 24 months
Free from biochemical recurrence
PSA <0.2 ng/mL
Measured: at 3, 12, and 24 months
Acute complications
Any complication according to Calvien classification
Measured: Within 30 days of surgery
Long-term complication
bladder neck contracture, lymphocele
Measured: >30 days
Estimated blood loss
Measured: Participants will be followed for the duration of the operation, an expected average of 3 hours
Operative time
Measured: Participants will be followed for the duration of the operation, an expected average of 3 hours
Length of hospital stay
Measured: Participants will be followed for the duration of the hospital stay, an expected average of 1-2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2011 (estimated)
- Study startMay 2011
- Primary completionFeb 2014
- Study completionFeb 2014
Why it stopped: Closing due to slow enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic NeoplasmsStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01365143
- Sponsor's protocol ID
- 11-002288
- Status last verified
- May 2014
- First submitted
- 26 May 2011
- Last updated
- 2 Jun 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Trial Comparing Robotic Versus Open Radical Prostatectomy
- ClinicalTrials.gov ID
- NCT01365143
- Acronym / sponsor ID
- 11-002288
- Conditions
- Prostatic Neoplasms, Adenocarcinoma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Closing due to slow enrollment
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 3 Jun 2011 (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.
To date, no study has prospectively compared open versus robotic radical prostatectomy in a randomized fashion for patients with prostate cancer. For patients with newly diagnosed prostate cancer who choose surgical management, the choice of surgical approach is often limited to surgeon preference and experience. This study will prospectively randomize patients with localized prostate cancer who are candidates for surgical management to open versus robotic radical prostatectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open Radical Prostatectomy | Active comparator | Procedure: Open Radical Prostatectomy |
| Robotic radical prostatectomy | Active comparator | Procedure: Robotic Radical Prostatectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Biopsy proven adenocarcinoma of the prostate
- Deemed a surgical candidate for a bilateral nerve bundle preservation
- Potent
- Continent of urine
- Surgical candidate for both open and robotic nerve-sparing radical prostatectomy
Key exclusion criteria (1 listed)
- Previous treatment of prostate cancer (radiation, hormones, etc.)
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 |
|---|---|---|
| Robotic Radical ProstatectomyRobotic assisted radical prostatectomy | Procedure or surgery | Robotic radical prostatectomy |
| Open Radical ProstatectomyOpen radical prostatectomy | Procedure or surgery | Open Radical Prostatectomy |
Primary outcome
Trifecta
Time frame: at 2 years
Free from biochemical recurrence, continent, and potent 2 years after radical prostatectomy
8 secondary outcomes
Continence
Time frame: at 3, 12, and 24 months
Potency
Time frame: at 3, 12, and 24 months
Free from biochemical recurrence
Time frame: at 3, 12, and 24 months
Acute complications
Time frame: Within 30 days of surgery
Long-term complication
Time frame: >30 days
Estimated blood loss
Time frame: Participants will be followed for the duration of the operation, an expected average of 3 hours
Operative time
Time frame: Participants will be followed for the duration of the operation, an expected average of 3 hours
Length of hospital stay
Time frame: Participants will be followed for the duration of the hospital stay, an expected average of 1-2 days
Results and safety
The study was stopped early (reason given: Closing due to slow enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Robotic Radical Prostatectomy and Open Radical Prostatectomy in people with Prostatic Neoplasms and Adenocarcinoma, run by Mayo Clinic 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 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: stopped early, as of the sponsor's last update on 2 Jun 2014. 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.
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: Closing due to slow enrollment). 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?
Trifecta (time frame: at 2 years). 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 2 Jun 2014.