Prostate CancerNCT00578123
Clinical and Quality of Life Outcomes After Open or Robotic-Assisted Laparoscopic Radical Prostatectomy
A study testing Quality of Life Questionnaires in people with Prostate Cancer and Quality of Life, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
The goal of the study is to look at surgical recovery and quality of life for men who have an open versus robotic-assisted laparoscopic radical prostatectomy (RP). RP is a procedure that removes the prostate gland. We want to see how long it will take you to return to health and strength after surgery. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer, Quality of Life
- What is being tested?
- Quality of Life Questionnaires
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 959 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2005to 3 Jun 2022
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Biopsy proven adenocarcinoma of the prostate
- Clinical stage T1-T2, NX or N0, Mx or M0
- Life expectancy greater than or equal to 10 years
- Planned radical prostatectomy
- Patients must be able to read and speak English, be free of cognitive impairment, and be reachable by telephone
Who cannot join
- Prior hormonal therapy for prostate cancer
- Prior pelvic radiation
- Prior chemotherapy for prostate cancer
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: Prospective Assessment of Clinical and Quality of Life Outcomes After Open or Robotic-Assisted Laparoscopic Radical Prostatectomy
The goal of the study is to look at surgical recovery and quality of life for men who have an open versus robotic-assisted laparoscopic radical prostatectomy (RP). RP is a procedure that removes the prostate gland. We want to see how long it will take you to return to health and strength after surgery. Quality-of-life (QOL) means how you feel about your life and your treatment of prostate cancer. The QOL surveys ask questions about your sexual, urinary and bowel functions. We will also ask questions about your use of health care services, out-of-pocket-spending on medical care and about your return to work, in order to learn about the financial impact of prostate cancer treatment. We hope that the surveys will help show how prostate cancer treatments affect your daily life after surgery.
Read the detailed description
This study will prospectively assess clinical outcomes in health-related quality of life (HRQOL) in men undergoing open, or robotic-assisted laparoscopic radical prostatectomy. Open radical prostatectomy is a frequently performed treatment for patients with clinically localized (cT1-T2) prostate cancer. The open technique stands as a benchmark against which all other treatments, including new surgical techniques, must be compared. Robotic-assisted and laparoscopic radical prostatectomy is considered an alternative surgical option for clinically localized prostate cancer. While this minimally invasive technique is more frequently being performed in the United States, a detailed comparison of the open and robotic-assisted laparoscopic techniques has not been performed. The relative risks and benefits of these surgical treatment options have not been explored in a contemporary group of patients treated at the same center by surgeons experienced in the open and robotic-assisted laparoscopic techniques. This study will address this deficiency in that follow-up information will be collected prospectively in consecutive patients undergoing open or robotic-assisted laparoscopic radical prostatectomy. While a prospective, randomized trial might be considered a more appropriate methodology to conduct such a comparative study, we have no baseline information, no guidelines to assess robotic-assisted laparoscopic competence, and a lack of skilled robotic-assisted laparoscopic pelvic surgeons to justify a lengthy and expensive trial. We will also collect information on health service utilization and employment during the 12-month postoperative period in order to assess the economic impacts of the different surgical approaches. While results from our proposed study will not necessarily be generalizable to all surgeons and may very well be a comparison of surgeons rather than techniques, the results will provide an initial assessment comparing experts in the open and robotic-assisted laparoscopic techniques. To date, no such comparison has been published. To our knowledge, no other center has expert surgeons in these techniques where such a study would be feasible. Because open techniques have improved dramatically over the past several years, and because the baseline data to be recorded in this proposal is not currently collected, use of historical controls for open radical prostatectomy would be inappropriate.
- Conditions
- Prostate Cancer, Quality of Life
- Being tested
- Quality of Life Questionnaires
- Keywords
- Prostate, Cancer, Quality of Life, Questionaires, 04-094
- Medical subject headings
- Prostatic Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality of Life QuestionnairesBehavioural
Three surveys you will need to complete. We will give you the surveys during your regularly scheduled clinic visits at three, six, and twelve months after surgery. You will NOT be asked to make additional appointments just for the study. You will have the option of completing some of the surveys in an easy to use computer format in the clinic waiting area or on paper.
| Study group | Role | What they receive |
|---|---|---|
| 1 Questionnaire | Other | Quality of Life Questionnaires Receives: Behavioral: Quality of Life Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare robotic-assisted radical prostatectomy (RALP), and open radical prostatectomy (ORP) with respect to potency function at 1 year, after adjusting for known confounding variables measured at baseline.
Measured: 1 year
Secondary outcomes (6)
To evaluate the recovery of continence after RALP or ORP.
Measured: 2 years
To evaluate patient convalescence after RALP or ORP.
Measured: 2 years
To evaluate operative details.
Including operative time, blood loss, intraoperative fluid requirements, type of anesthesia, number and type of surgical drains, status of the neurovascular bundles including whether or not nerve grafting was performed, incision length, and other ancillary procedures for RALP or ORP
Measured: 2 years
To evaluate inpatient (hospital) details
Including time in the post-anesthesia care unit, hospital convalescence, day of oral intake, day of ambulation, analgesia requirements, daily weights, length of time and output from surgical drains, hemoglobin and creatinine, complications, and length of hospital stay.
Measured: 2 years
To evaluate post-discharge (home) details.
Including analgesic use, return to normal activities/work, time of urinary catheterization, need for catheter replacement, hemoglobin, complications, visit to emergency room or unscheduled clinic visits, and biochemical outcomes (serum PSA levels) following surgery.
Measured: 2 years
To evaluate health service utilization, out-of-pocket spending and changes in employment following RALP or ORP.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2007 (estimated)
- Study startJul 2005
- Primary completion3 Jun 2022
- Study completion3 Jun 2022
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 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 959 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- The Cleveland Clinic
- Responsible party
- Sponsor
- Investigators
- James Eastham, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00578123
- Sponsor's protocol ID
- 04-094
- Status last verified
- Jun 2022
- First submitted
- 18 Dec 2007
- Last updated
- 8 Jun 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Assessment of Clinical and Quality of Life Outcomes After Open or Robotic-Assisted Laparoscopic Radical Prostatectomy
- ClinicalTrials.gov ID
- NCT00578123
- Acronym / sponsor ID
- 04-094
- Conditions
- Prostate Cancer, Quality of Life
- Keywords
- Prostate, Cancer, Quality of Life, Questionaires, 04-094
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 959 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- The Cleveland Clinic
- Study start
- Jul 2005
- Primary completion
- 3 Jun 2022 (actual)
- Study completion
- 3 Jun 2022 (actual)
- First posted
- 20 Dec 2007 (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.
The goal of the study is to look at surgical recovery and quality of life for men who have an open versus robotic-assisted laparoscopic radical prostatectomy (RP). RP is a procedure that removes the prostate gland. We want to see how long it will take you to return to health and strength after surgery. Quality-of-life (QOL) means how you feel about your life and your treatment of prostate cancer. The QOL surveys ask questions about your sexual, urinary and bowel functions. We will also ask questions about your use of health care services, out-of-pocket-spending on medical care and about your return to work, in order to learn about the financial impact of prostate cancer treatment. We hope that the surveys will help show how prostate cancer treatments affect your daily life after surgery.
Detailed description
This study will prospectively assess clinical outcomes in health-related quality of life (HRQOL) in men undergoing open, or robotic-assisted laparoscopic radical prostatectomy. Open radical prostatectomy is a frequently performed treatment for patients with clinically localized (cT1-T2) prostate cancer. The open technique stands as a benchmark against which all other treatments, including new surgical techniques, must be compared. Robotic-assisted and laparoscopic radical prostatectomy is considered an alternative surgical option for clinically localized prostate cancer. While this minimally invasive technique is more frequently being performed in the United States, a detailed comparison of the open and robotic-assisted laparoscopic techniques has not been performed. The relative risks and benefits of these surgical treatment options have not been explored in a contemporary group of patients treated at the same center by surgeons experienced in the open and robotic-assisted laparoscopic techniques. This study will address this deficiency in that follow-up information will be collected prospectively in consecutive patients undergoing open or robotic-assisted laparoscopic radical prostatectomy. While a prospective, randomized trial might be considered a more appropriate methodology to conduct such a comparative study, we have no baseline information, no guidelines to assess robotic-assisted laparoscopic competence, and a lack of skilled robotic-assisted laparoscopic pelvic surgeons to justify a lengthy and expensive trial. We will also collect information on health service utilization and employment during the 12-month postoperative period in order to assess the economic impacts of the different surgical approaches. While results from our proposed study will not necessarily be generalizable to all surgeons and may very well be a comparison of surgeons rather than techniques, the results will provide an initial assessment comparing experts in the open and robotic-assisted laparoscopic techniques. To date, no such comparison has been published. To our knowledge, no other center has expert surgeons in these techniques where such a study would be feasible. Because open techniques have improved dramatically over the past several years, and because the baseline data to be recorded in this proposal is not currently collected, use of historical controls for open radical prostatectomy would be inappropriate.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 Questionnaire | Other | Behavioral: Quality of Life QuestionnairesQuality of Life Questionnaires |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Biopsy proven adenocarcinoma of the prostate
- Clinical stage T1-T2, NX or N0, Mx or M0
- Life expectancy greater than or equal to 10 years
- Planned radical prostatectomy
- Patients must be able to read and speak English, be free of cognitive impairment, and be reachable by telephone
Key exclusion criteria (3 listed)
- Prior hormonal therapy for prostate cancer
- Prior pelvic radiation
- Prior chemotherapy for prostate 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 |
|---|---|---|
| Quality of Life QuestionnairesThree surveys you will need to complete. We will give you the surveys during your regularly scheduled clinic visits at three, six, and twelve months after surgery. You will NOT be asked to make additional appointments just for the study. You will have the option of completing some of the surveys in an easy to use computer format in the clinic waiting area or on paper. | Behavioural | 1 Questionnaire |
Primary outcome
To compare robotic-assisted radical prostatectomy (RALP), and open radical prostatectomy (ORP) with respect to potency function at 1 year, after adjusting for known confounding variables measured at baseline.
Time frame: 1 year
6 secondary outcomes
To evaluate the recovery of continence after RALP or ORP.
Time frame: 2 years
To evaluate patient convalescence after RALP or ORP.
Time frame: 2 years
To evaluate operative details.
Time frame: 2 years
To evaluate inpatient (hospital) details
Time frame: 2 years
To evaluate post-discharge (home) details.
Time frame: 2 years
To evaluate health service utilization, out-of-pocket spending and changes in employment following RALP or ORP.
Time frame: 2 years
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 8 Jun 2022.
- 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.
James Eastham, 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 Quality of Life Questionnaires in people with Prostate Cancer and Quality of Life, 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 5 inclusion and 3 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 8 Jun 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 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 compare robotic-assisted radical prostatectomy (RALP), and open radical prostatectomy (ORP) with respect to potency function at 1 year, after adjusting for known confounding variables measured at baseline. (time frame: 1 year). 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 8 Jun 2022.