Clinical Trial of Approaches to Prostate Cancer Surgery

Browse trials for

• Prostatic Neoplasms 6,370

Keywords

• radical prostatectomy
• nerve sparing
• Retzius sparing

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

This study's planned enrollment of 600 is above the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.

Lead sponsor

Weill Medical College of Cornell University is the lead sponsor of 867 studies on the registry; 160 are open to participants now.

Of its 119 completed or terminated interventional studies of FDA-regulated products, 91 (76%) have results posted.

Study arms

• Active comparator
  Robot-assisted radical prostatectomy (RP)

  The conventional robotic-assisted radical prostatectomy is the gold standard approach to prostate cancer surgery.

  Procedure: Robot-assisted radical prostatectomy (RP)

• Experimental
  Pelvic fascia-sparing robot-assisted radical prostatectomy (PFS-RP)

  A novel, posterior approach to radical prostatectomy that preserves the dorsal vascular complex, nerves and fascial support structures that overlie the anterior prostate. These structures are disrupted and removed during conventional radical prostatectomy.

  Procedure: Pelvic fascia-sparing robot-assisted radical prostatectomy (PFS-RP)

Interventions

• ProcedureRobot-assisted radical prostatectomy (RP)

  The conventional approach to prostate cancer surgery

• ProcedurePelvic fascia-sparing robot-assisted radical prostatectomy (PFS-RP)

  A novel, posterior approach to radical prostatectomy that preserves the dorsal vascular complex, nerves and fascial support structures that overlie the anterior prostate.

Primary outcomes

1. Surgical Margin Status as assessed by surgical pathology results

   Presence of cancer cells at the prostate margin is standardized as a positive surgical margin through professional guideline consensus.

   Time frame: 1 week post-surgery

2. Biochemical Recurrence as assessed by Prostate Specific Antigen (PSA)

   Prostate specific antigen (PSA) levels are obtained from standard of care blood tests, and PSA values are measured in ng/mL. In accordance with National Comprehensive Cancer Network (NCCN) guidelines, investigators will capture PSA persistence as failure of PSA to fall to undetectable levels, and PSA recurrence as an undetectable PSA after surgery with a subsequent detectable PSA that increases on 2 or more determinations.

   Time frame: 6 months post-surgery

3. Biochemical Recurrence as assessed by Prostate Specific Antigen (PSA)

   Prostate specific antigen (PSA) levels are obtained from standard of care blood tests, and PSA values are measured in ng/mL.

   Time frame: 12 months post-surgery

4. Biochemical Recurrence as assessed by Prostate Specific Antigen (PSA)

   Prostate specific antigen (PSA) levels are obtained from standard of care blood tests, and PSA values are measured in ng/mL.

   Time frame: 24 months post-surgery

Secondary outcomes

1. Surgery-Related Adverse Events as assessed by the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)

   The questionnaire will include 20 items from the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE), survey items pertinent to short-stay cancer surgery. The questionnaire will assess patient-reported complications and adverse events, such as constipation, nausea and vomiting, fever, chills, fatigue, pain, shortness of breath, swelling and bruising, redness and discharge at the surgical incision site, anxiety, and flatulence (ileus). It will also assess patient contacts with physicians and admittance to urgent care or the emergency room.

   Time frame: Up to 30 days following surgery

2. Change in Urinary and Sexual Function, as measured by the Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP)

   The Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP) is a 7-item questionnaire assessing two health-related quality of life domains: urinary and sexual function. All questions refer to patients' health and symptoms in the last four weeks. Each domain is scored out of 12 points, with higher scores indicating more complications. In total, the EPIC-CP score is the final sum of the two domains, with higher scores indicating more issues related to overall prostate cancer quality of life.

   Time frame: Baseline, 1 month, 6 months, 12 months, and 24 months post-surgery

3. Change in Patient-Reported Penile Shortening and Sexual Function, as measured by a 5-item questionnaire

   This is a 5-item questionnaire, published in the New England Journal of Medicine (NEJM), that has face validity for assessing penile shortening, self-esteem, and erectile function after radical prostatectomy. Question 1 assesses patients' perceived penile length post-surgery, compared to penile length at 30 years of age. It consists of two possible responses: Yes or No. Questions 2 and 3 assesses patients' ability to obtain and quality of spontaneous morning erections and sexual activity-related erections. It consists of five possible responses: ranging from "No erections" to "Erections always sufficient". Question 4 is a visual digital scale assessing patients' present quality of life. It is scored on a scale of 1-7, with higher scores indicating high quality of life. Question 5 is a visual digital scale assessing patients' present self-esteem. It is scored on a scale of 1-7, with higher scores indicating high self-esteem.

   Time frame: Baseline, 1 month, 6 months, 12 months, and 24 months post-surgery

4. Change in patient-Reported Penile Curvature/Deformity (Peyronie's Disease), as measured by a 3-item questionnaire

   This is a validated, 3-item questionnaire assessing presence of Peyronie's disease. The penile deformity items were validated by blinded clinical examination with 100% sensitivity and 99.4% specificity. Question 1 assesses penile hardening/plaques in the flaccid state. Question 2 assesses penile curvature in the erect state. Question 3 assesses pain associated with erection. Each question consists of two possible responses: Yes or No.

   Time frame: Baseline, 1 month, 6 months, 12 months, and 24 months post-surgery

5. Patient-reported Decision Regret, as measured by a 5-item questionnaire

   This is a 5-item questionnaire assessing treatment regret that was developed and validated in men with prostate cancer. Each item is scored on a 5 point scale ranging from "Strongly Agree" to "Strongly Disagree". Responses are converted to a score ranging from 0-100, with higher scores indicating more regret.

   Time frame: 12 months post-surgery

6. Patient-reported Decision Regret, as measured by a 5-item questionnaire

   This is a 5-item questionnaire assessing treatment regret that was developed and validated in men with prostate cancer.

   Time frame: 24 months post-surgery

Publications

• Stangl-Kremser J, Kowalczyk K, Schaeffer EM, Allaf M, Scherr D, Yang X, Matoso A, Azumi N, Robinson B, Vickers A, Hu JC. Study protocol for a prospective, multi-centered randomized controlled trial comparing pelvic fascia-sparing radical prostatectomy with conventional robotic-assisted prostatectomy: The PARTIAL trial. Contemp Clin Trials. 2023 May;128:107168. doi: 10.1016/j.cct.2023.107168. Epub 2023 Apr 2. PubMed 37015291 ↗

Individual participant data

Plan to share: No