Effectiveness of Open and Robotic Prostatectomy

Prostate Cancer Clinical Trial

— PROSTQA-RP2  

Official title:

Effectiveness of Open and Robotic Prostatectomy: The PROSTQA-RP2 Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01325506
• Other study ID #: 10-155
• Status: Active, not recruiting
• Start date: September 2010
• Est. completion date: February 2024

Study information

• Verified date: August 2023
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 600
• Est. completion date: February 2024
• Est. primary completion date: February 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Other:
• Questionnaire
Questionnaire, telephone interviews, and clinical follow-up

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Emory Healthcare	Atlanta	Georgia
United States	Johns Hopkins	Baltimore	Maryland
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Cleveland Clinic	Cleveland	Ohio
United States	Vanderbilt University	Nashville	Tennessee
United States	Washington University Medical Center St. Louis	Saint Louis	Missouri
United States	University of California, San Francisco	San Francisco	California

Sponsors (10)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center	Brigham and Women's Hospital, Dana-Farber Cancer Institute, Emory University, Johns Hopkins University, The Cleveland Clinic, University of California, San Francisco, University of Michigan, Vanderbilt University, Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

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