Prostate CancerNCT00292019
Robotic Laparoscopic Radical Prostatectomy
An observational study of Prostate Cancer, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
This is a pilot study to evaluate the role of RALRP in the management of localized prostate cancer. Read more about this study
- Who is it for?
- Ages 40 to 65 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Laparoscopic
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 4 Mar 2004to 30 Jun 2016
- Phase
- Observational
- 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 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Prostate cancer patients eligible for a radical prostatectomy
Who may be able to join
- Informed Consent
- Locally confined, stage T1a, T2a or T2b prostate cancer
- Aged 40-65 and judged by the study doctor to be a suitable candidate for a radical prostatectomy.
- Serum prostate specific antigen equal to or less than 10mg/ml
- Histologically confirmed adenocarcinoma of the prostate
- Gleason score equal to or less than 7
- Life expectancy of greater than 10 years.
- Prostate size on TRUS measurement less than 40 grams
Who cannot join
- Patients who have undergone prior hormone therapy.
- Patients with a previous transurethral resectioning of the prostate (TURP)
- History of other cancers other than basal cell carcinoma.
- Patients with any prior abdominal surgery.
- Any condition, or history of illness or surgery than, in the opinion of the investigator, might confound the results of the study or pose additional risk to the patient (eg significant cardiovascular conditions)
- Patients with a large median lobe of the prostate. -
- -
Trial locations and contacts
1 site in 1 country.
About this study
This is a pilot study to evaluate the role of RALRP in the management of localized prostate cancer.
Read the detailed description
To establish a robotic-assisted laparoscopic radical prostatectomy programme at the University of Western Ontario/London Health Sciences Centre and to critically evaluate the role of this programme in the management of localized prostate cancer in surgical candidates Details of surgical procedure, operative outcome, patient outcome including quality of life will be collected.
- Conditions
- Prostate Cancer
- Being tested
- Laparoscopic
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LaparoscopicProcedure or surgery
Patients with prostate cancer who are eligible for a radical prostatectomy will have their surgery conducted with the aid of surgical robots.
| Study group | Role | What they receive |
|---|---|---|
| Robotic prostatectomy | Patients who are eligible for a radical prostatectomy will have their surgery conducted with the aid of surgical robotics. Receives: Procedure: Laparoscopic |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2006 (estimated)
- Study start4 Mar 2004
- Primary completion30 Jun 2016
- Study completion30 Jun 2016
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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joseph Chin, MD< FRCSC, Principal investigator, London Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00292019
- Sponsor's protocol ID
- R-04-030
- Other IDs
- 10280
- Status last verified
- Aug 2017
- First submitted
- 14 Feb 2006
- Last updated
- 28 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robotic Laparoscopic Radical Prostatectomy
- ClinicalTrials.gov ID
- NCT00292019
- Acronym / sponsor ID
- R-04-030
- Conditions
- Prostate Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- 4 Mar 2004 (actual)
- Primary completion
- 30 Jun 2016 (actual)
- Study completion
- 30 Jun 2016 (actual)
- First posted
- 15 Feb 2006 (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 is a pilot study to evaluate the role of RALRP in the management of localized prostate cancer.
Detailed description
To establish a robotic-assisted laparoscopic radical prostatectomy programme at the University of Western Ontario/London Health Sciences Centre and to critically evaluate the role of this programme in the management of localized prostate cancer in surgical candidates Details of surgical procedure, operative outcome, patient outcome including quality of life will be collected.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Robotic prostatectomy | – | Procedure: LaparoscopicPatients who are eligible for a radical prostatectomy will have their surgery conducted with the aid of surgical robotics. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Prostate cancer patients eligible for a radical prostatectomy
Key inclusion criteria (8 listed)
- Informed Consent
- Locally confined, stage T1a, T2a or T2b prostate cancer
- Aged 40-65 and judged by the study doctor to be a suitable candidate for a radical prostatectomy.
- Serum prostate specific antigen equal to or less than 10mg/ml
- Histologically confirmed adenocarcinoma of the prostate
Key exclusion criteria (7 listed)
- Patients who have undergone prior hormone therapy.
- Patients with a previous transurethral resectioning of the prostate (TURP)
- History of other cancers other than basal cell carcinoma.
- Patients with any prior abdominal surgery.
- Any condition, or history of illness or surgery than, in the opinion of the investigator, might confound the results of the study or pose additional risk to the patient (eg significant cardiovascular conditions)
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 |
|---|---|---|
| LaparoscopicPatients with prostate cancer who are eligible for a radical prostatectomy will have their surgery conducted with the aid of surgical robots. | Procedure or surgery | Robotic prostatectomy |
Primary outcome
Not reported in the source record.
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 28 Aug 2017.
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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.
Joseph Chin, MD< FRCSC principal investigator
London Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
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 8 inclusion and 7 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 28 Aug 2017. 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 Canada. 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.
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 28 Aug 2017.