Clinical trial · Observational
Effectiveness of Open and Robotic Prostatectomy
Effectiveness of Open and Robotic Prostatectomy: The PROSTQA-RP2 Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Questionnaire | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Prostatectomy subjects
- interventionNames
- Other: Questionnaire
Primary outcomes (2)
- measure
- To compare clinical outcomes between robot assisted laparoscopic prostatectomy (RALP) and open retropubic prostatectomy (ORP).
- timeFrame
- Eligible participants will initially be followed for 2 years with the possibility for up to 12 years.
- description
- 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).
- measure
- To compare patient-reported outcomes between robot assisted laparoscopic prostatectomy (RALP) and open retropubic prostatectomy (ORP).
- timeFrame
- Eligible participants will initially be followed for 2 years with the possibility for up to 12 years.
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDChang 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. PMID 34433304