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Effectiveness of Open and Robotic Prostatectomy (PROSTQA-RP2)

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ClinicalTrials.gov Identifier: NCT01325506
Recruitment Status : Active, not recruiting
First Posted : March 29, 2011
Last Update Posted : June 25, 2020
Sponsor:
Collaborators:
Brigham and Women's Hospital
The Cleveland Clinic
Johns Hopkins University
University of California, San Francisco
University of Michigan
Vanderbilt University
Washington University School of Medicine
Emory University
Information provided by (Responsible Party):
Peter Chang, MD MPH, Beth Israel Deaconess Medical Center

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.

Condition or disease Intervention/treatment
Prostate Cancer Other: Questionnaire

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).

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Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effectiveness of Open and Robotic Prostatectomy: The PROSTQA-RP2 Study
Study Start Date : September 2010
Estimated Primary Completion Date : February 2024
Estimated Study Completion Date : February 2024

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Prostatectomy subjects Other: Questionnaire
Questionnaire, telephone interviews, and clinical follow-up




Primary Outcome Measures :
  1. To compare clinical outcomes between robot assisted laparoscopic prostatectomy (RALP) and open retropubic prostatectomy (ORP). [ Time Frame: Eligible participants will initially be followed for 2 years with the possibility for up to 12 years. ]
    Outcomes include: acute clinical morbidity (thromboembolic events, bleeding requiring transfusion, surgical infection, other events requiring intervention within 30 days of prostatectomy) and satisfaction with overall treatment outcome; cancer control (surgical margins, PSA recurrence-free survival, requirement of salvage or adjuvant treatment).

  2. To compare patient-reported outcomes between robot assisted laparoscopic prostatectomy (RALP) and open retropubic prostatectomy (ORP). [ Time Frame: Eligible participants will initially be followed for 2 years with the possibility for up to 12 years. ]
    Outcomes include: patient-reported outcomes (urinary incontinence, erectile dysfunction) and satisfaction with overall treatment outcome.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects with localized prostate cancer who have elected to undergo a robot assisted laparoscopic prostatectomy or an open prostatectomy from participating clinical sites
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01325506


Locations
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United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
United States, Georgia
Emory Healthcare
Atlanta, Georgia, United States, 30322
United States, Maryland
Johns Hopkins
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
United States, Missouri
Washington University Medical Center St. Louis
Saint Louis, Missouri, United States, 63110
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Dana-Farber Cancer Institute
Brigham and Women's Hospital
The Cleveland Clinic
Johns Hopkins University
University of California, San Francisco
University of Michigan
Vanderbilt University
Washington University School of Medicine
Emory University
Investigators
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Principal Investigator: Martin Sanda, MD Emory Healthcare
Principal Investigator: Peter Chang, MD, MPH Beth Israel Deaconess Medical Center
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Responsible Party: Peter Chang, MD MPH, Principal Investigator, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT01325506    
Other Study ID Numbers: 10-155
First Posted: March 29, 2011    Key Record Dates
Last Update Posted: June 25, 2020
Last Verified: June 2020
Keywords provided by Peter Chang, MD MPH, Beth Israel Deaconess Medical Center:
Prostatectomy
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases