Effectiveness of Open and Robotic Prostatectomy

NCT ID: NCT01325506

Last Updated: 2024-11-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 677 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2024-10-31

Brief Summary

Prostate cancer is the most common cancer in American men. Surgical removal of the entire prostate (prostatectomy) is one option among the various ways to treat prostate cancer. The use of robot assistance for prostatectomy has become common place, but its effectiveness has not been compared to standard open prostatectomy in trials carried out at more than one medical institution in which participants are identified and followed forward in time. Robot assisted and standard open prostatectomy health related quality of life (HRQOL) outcomes have not been compared in a prospective, multi-centered study. Prostatectomy can have side effects that can change with time. This research study seeks to determine how common and how long-lasting such side effects are; to find out what features of individual men's cancers and what features of the treatments affect those side effects. This study also seeks to identify factors that affect the quality of prostate cancer care by looking at how satisfied men are with their prostate cancer care. Through these findings, this study aims to allow treatment side effects to be anticipated more accurately for individual patients, and to provide a means for determining the quality of prostate care.

Detailed Description

The investigators will follow your prostate cancer treatment outcomes and health related quality of life following prostatectomy by asking you direct questions, collect information from medical records and phone interviews.

Information about your prostate cancer treatment, and related health concerns, and information regarding the cost of care, may also be collected from your medical record, other medical center sources, and your primary care provider (PCP). Clinical information will be collected: prior to beginning treatment (prostatectomy); 6 month, 12 months, 18 months, and 24 months after your prostatectomy; once a year thereafter for possibly up to 12 years.

You will be asked to take part in six telephone interviews regarding quality of life, possible therapy side effects, and satisfaction with prostate cancer therapy. Each phone interview should last 15-25 minutes. All questions are voluntary. The phone interviews will be conducted: prior to beginning treatment (prostatectomy); 2 months, 6 months, 12 months, 18 months, and 24 months after prostatectomy; 10 additional phone interviews may be conducted (once a year thereafter, for possibly up to 12 years).

Conditions

Prostate Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Prostatectomy subjects

Questionnaire

Intervention Type: OTHER

Questionnaire, telephone interviews, and clinical follow-up

Interventions

Questionnaire

Questionnaire, telephone interviews, and clinical follow-up

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Early stage prostate cancer (AJCC [2002] clinical stage < or = T2NXMX; T stage is based on rectal exam findings alone).
• Gleason score based on local pathology within 12 months of registration. (Patients with an original diagnosis of prostate cancer proceeding 12 months are also eligible but pathology confirmation of cancer within 12 months of registration is required.)
• Serum PSA test result from within 12 months of registration
• Able to participate in baseline and follow-up phone interviews conducted in English
• Scheduled to undergo Open Radical Prostatectomy or Robotic Assisted Laparoscopic Prostatectomy

Exclusion Criteria

• Previous definitive primary prostate cancer therapy (prostatectomy, external radiation, brachytherapy, cryotherapy, or other interventions)
• Previous radiation therapy to the pelvis
• Previous major reconstructive or extirpative pelvic surgery (including but not limited to abdominal-perineal resection, or penile implant)
• Previous androgen suppression therapy (LHrH agonist or antagonist), anti-androgen therapy (Casodex, Flutamide, or Nilandron), or estrogen therapy (DES or PC-SPEZ). (Prior or current finasteride or dutasteride therapy is allowed)
• Known urethral stricture
• Urostomy or colostomy
• Chronic urinary catheterization

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: collaborator

The Cleveland Clinic

OTHER

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: collaborator

Vanderbilt University

OTHER

Sponsor Role: collaborator

Washington University School of Medicine

OTHER

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role: collaborator

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Peter Chang

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Martin Sanda, MD

Role: PRINCIPAL_INVESTIGATOR

Emory Healthcare

Peter Chang, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Medical Center

Locations

University of California, San Francisco

San Francisco, California, United States

Emory Healthcare

Atlanta, Georgia, United States

Johns Hopkins

Baltimore, Maryland, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

University of Michigan

Ann Arbor, Michigan, United States

Washington University Medical Center St. Louis

St Louis, Missouri, United States

Cleveland Clinic

Cleveland, Ohio, United States

Vanderbilt University

Nashville, Tennessee, United States

Countries

United States

References

Chang P, Wagner AA, Regan MM, Smith JA, Saigal CS, Litwin MS, Hu JC, Cooperberg MR, Carroll PR, Klein EA, Kibel AS, Andriole GL, Han M, Partin AW, Wood DP, Crociani CM, Greenfield TK, Patil D, Hembroff LA, Davis K, Stork L, Spratt DE, Wei JT, Sanda MG; PROST-QA/RP2 Consortium. Prospective Multicenter Comparison of Open and Robotic Radical Prostatectomy: The PROST-QA/RP2 Consortium. J Urol. 2022 Jan;207(1):127-136. doi: 10.1097/JU.0000000000002176. Epub 2021 Aug 26.

Reference Type: DERIVED

PMID: 34433304 (View on PubMed)

Other Identifiers

10-155

Identifier Type: -

Identifier Source: org_study_id