Clinical and Quality of Life Outcomes After Open or Robotic-Assisted Laparoscopic Radical Prostatectomy

NCT00578123 | Completed

• 1 other identifier: 04-094
• Study Type: interventional
• Target: 959
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Prostate Cancer; Quality of Life

Keywords

Prostate; Cancer; Quality of Life; Questionaires; 04-094

Outcome Measures

Primary Outcomes (1)

• 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.

  1 year

Secondary Outcomes (6)

• To evaluate the recovery of continence after RALP or ORP.

  2 years

• To evaluate patient convalescence after RALP or ORP.

  2 years

• To evaluate operative details.

  2 years

• To evaluate inpatient (hospital) details

  2 years

• To evaluate post-discharge (home) details.

  2 years

Study Arms (1)

1 Questionnaire

OTHER

Quality of Life Questionnaires

Behavioral: Quality of Life Questionnaires

Interventions

Quality of Life Questionnaires BEHAVIORAL

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.

1 Questionnaire

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Prior hormonal therapy for prostate cancer
• Prior pelvic radiation
• Prior chemotherapy for prostate cancer

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• The Cleveland Clinic: collaborator

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan-Kettering Cancer Center

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• James Eastham, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2007
• First Posted: December 20, 2007
• Study Start: July 1, 2005
• Primary Completion: June 3, 2022
• Study Completion: June 3, 2022
• Last Updated: June 8, 2022

Record last verified: 2022-06

Locations

US (1)