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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 December 2012 |
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Main ID: |
NCT00578123 |
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Date of registration:
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18/12/2007 |
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Primary sponsor: |
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Public title:
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Clinical and Quality of Life Outcomes After Open or Robotic-Assisted Laparoscopic Radical Prostatectomy
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Scientific title:
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Prospective Assessment of Clinical and Quality of Life Outcomes After Open or Robotic-Assisted Laparoscopic Radical Prostatectomy |
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Date of first enrolment:
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July 2005 |
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Target sample size:
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959 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00578123 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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Countries of recruitment
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United States
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Contacts
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Name:
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James Eastham, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Memorial Sloan-Kettering Cancer Center |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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
Exclusion Criteria:
- Prior hormonal therapy for prostate cancer
- Prior pelvic radiation
- Prior chemotherapy for prostate cancer
Age minimum:
N/A
Age maximum:
N/A
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Prostate Cancer
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Quality of Life
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Intervention(s)
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Behavioral: Quality of Life Questionnaires
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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To evaluate health service utilization, out-of-pocket spending and changes in employment following RALP or ORP.
[Time Frame: 2 years]
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To evaluate inpatient (hospital) details
[Time Frame: 2 years]
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To evaluate operative details.
[Time Frame: 2 years]
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To evaluate patient convalescence after RALP or ORP.
[Time Frame: 2 years]
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To evaluate post-discharge (home) details.
[Time Frame: 2 years]
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To evaluate the recovery of continence after RALP or ORP.
[Time Frame: 2 years]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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