Program Official

Principal Investigator

Jim
Hu
Awardee Organization

Weill Medical Coll Of Cornell Univ
United States

Fiscal Year
2023
Activity Code
R01
Early Stage Investigator Grants (ESI)
Not Applicable
Project End Date

Pelvic fascia spARing radical prostatectomy TrIAL (PARTIAL)

Radical prostatectomy (RP) is a standard treatment for localized prostate cancer with 60,000 procedures per year in the U.S. Commonly recognized long-term adverse events of RP include persistent urinary incontinence (~20%) and erectile dysfunction (~65%). Less commonly known risks include penile shortening (~50%), penile deformity/curvature (~15%), and inguinal hernia (~15%). These adverse events lower healthrelated quality of life, cause decision regret and require additional treatment. A new surgical technique, pelvic fascia-sparing RP (PFS-RP), preserves fascial support structures, arterial supply to the penis, and nerves that are severed and resected during conventional RP. Several retrospective series have shown significaly reduced urinary and erectile dysfunction after PFS-RP. However, these studies have been small and had limited followup for oncologic endpoints. A multi-center, randomized controlled trial (RCT) with longer follow-up is clearly indicated. However, adequately powered surgical RCTs face significant challenges: 1) a traditional RCT of this new technique would cost ~$10 million; and 2) typically, such RCTs accrue only about six patients per center per year and often close prematurely due to low accrual. Indeed, there is almost a complete absence of sufficiently powered RCTs in oncologic surgery. After considering these challenges, we developed two innovative methodological approaches that have strong published, preliminary data. The first is to use a two-stage RCT consent that lowers information overload, decisional burden, and anxiety. Making consent easier for patients also reduces the burden on surgeon investigators making them more willing to accrue. Preliminary data suggest that two-stage consent dramatically improves accrual – in one recent study, 98% of eligible patients were accrued - while maintaining patient understanding of consent as assessed by a standard questionnaire. The second innovation employs a web-based portal to incentivize self-entry of patient-reported outcomes by giving patients feedback and advice in response to their answers. This portal has already been used by ~15,000 patients and captured the endpoint for two RCTs. We propose a RCT using these two novel methodologic approaches. This will randomized 600 patients to PFS-RP or traditional RP conducted at four centers that receive NCI SPORE awards for prostate cancer. We will test whether PFS-RP is able to reduce urinary and erectile function, as well as immediate surgical complications, while being non-inferior for cancer control. The study will include a rigorous surgeon quality assurance approach, involving surgical videos uploaded to a central site and quantitative scoring of discrete surgical steps. Successful completion of the study would not only provide evidence on the best practice for one of the most common cancer operations but provide a novel methodological approach that could facilitate future studies in surgical oncology.

Publications

  • Cheng E, Gereta S, Zhang TR, Zhu A, Basourakos SP, McKernan C, Xie S, Vickers AJ, Laviana AA, Hu JC. Same-Day Discharge vs Inpatient Robotic-Assisted Radical Prostatectomy: Complications, Time-Driven Activity-Based Costing, and Patient Satisfaction. The Journal of urology. 2023 Dec;210(6):856-864. Epub 2023 Aug 28. PMID: 37639456
  • Borregales LD, DeMeo G, Gu X, Cheng E, Dudley V, Schaeffer EM, Nagar H, Carlsson S, Vickers A, Hu JC. Grade Migration of Prostate Cancer in the United States During the Last Decade. Journal of the National Cancer Institute. 2022 Jul 11;114(7):1012-1019. PMID: 35348709
  • Kaplan-Marans E, Zhang TR, Hu JC. Differing Recommendations on Prostate Biopsy Approach to Minimize Infections: An Examination of the European Association of Urology and American Urological Association Guidelines. European urology. 2023 Nov;84(5):445-446. Epub 2023 Jun 7. PMID: 37296040
  • Gereta S, Hung M, Hu JC. Robotic-assisted retroperitoneal lymph node dissection for testicular cancer. Current opinion in urology. 2023 Jul 1;33(4):274-280. Epub 2023 Apr 4. PMID: 37014761
  • Borregales LD, Tzeng M, Ramaswamy A, Gu X, Davuluri M, Nagar H, Hu JC. Prostate cancer grade migration and facility-level treatment trends for grade group 1 disease. JNCI cancer spectrum. 2023 Mar 1;7. (2). PMID: 36840651
  • Zhang TR, Thorogood SL, Sze C, Fisch R, Chughtai B, Te A, Lee RK, Hu JC. Current Practice Patterns in the Surgical Management of Benign Prostatic Hyperplasia. Urology. 2023 May;175:157-162. Epub 2023 Mar 1. PMID: 36863599
  • Tzeng M, Basourakos SP, Davuluri M, Nagar H, Ramaswamy A, Cheng E, DeMeo G, Hu JC. Evolving Trends in the Management of Low-Risk Prostate Cancer. Clinical genitourinary cancer. 2022 Oct;20(5):423-430. Epub 2022 May 11. PMID: 35701333
  • Kaplan-Marans E, Zhang TR, Zhao LC, Hu JC. Transgender women with prostate cancer are under-represented in national cancer registries. Nature reviews. Urology. 2023 Apr;20(4):195-196. PMID: 36473946
  • Basourakos SP, Gulati R, Vince RA Jr, Spratt DE, Lewicki PJ, Hill A, Nyame YA, Cullen J, Markt SC, Barbieri CE, Hu JC, Trapl E, Shoag JE. Harm-to-Benefit of Three Decades of Prostate Cancer Screening in Black Men. NEJM evidence. 2022 Jun;1. (6). Epub 2022 May 15. PMID: 35721307
  • Brant A, Campi R, Carrion DM, Esperto F, Sze C, Johnson JP, Hu JC, Borregales LD, ICE‐OUT (International Collaboration on Experiences and Opinions of Urology Trainees) Collaborators, Afferi L, Checcucci E, Gürtan E, Karazanashvili N, Khelif A, Mantica G, Özenç G, Tzelves L, Quaresma V. Findings from an international survey of urology trainee experience with prostate biopsy. BJU international. 2022 Nov 24. Epub 2022 Nov 24. PMID: 36424894
  • Borregales LD, DeMeo G, Gu X, Cheng E, Dudley V, Schaeffer EM, Nagar H, Carlsson S, Vickers A, Hu JC. Response to Takahashi. Journal of the National Cancer Institute. 2022 Nov 14;114(11):1557-1558. PMID: 35880831

Clinical Trials

Study Name Clinical Trial ID
Clinical Trial of Approaches to Prostate Cancer Surgery NCT05155501