Pelvic fascia sparing radical prostatectomy trial (partial)

Active Project Grant Awarded Last action

Award ID
R01CA259173
Recipient
Awarding agency
Obligated
$4,517,532

Award facts

Assistance listing
93.395 Cancer Treatment Research
Completion date 73% complete
Originally
Place of performance
New York, NY 10065, USA

Award details come from USAspending.gov.

Description

As the agency reported it.

Abstract
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 health- related 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 follow- up 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.

Transactions

Action Obligated Date
Amendment $638,257
Amendment $638,257
Amendment $405,053
Amendment $634,802
Amendment $0
Amendment $0
Amendment $733,721
Amendment $733,721
Original award $733,721

Subawards

Subrecipient Amount Awarded
The Johns Hopkins University PERSONNEL Edward Schaeffer, MD/PhD, PI (1.27 CM) Dr. Schaeffer is Chair of the Department of Urology and the Edmund Andrews Professor of Urology at Northwestern… $179,590
Beth Israel Deaconess Medical Center Incorporated The subrecipient institution will be an enrollment site for this study, performing the following tasks: randomize men to pelvic fascia sparing (PFS-RP) vs.… $65,582
Georgetown University BUDGET JUSTIFICATION PERSONNEL Kowalczyk, Ketih (PD/PI – 9.47% Effort; 1.14 CM) Keith J. Kowalczyk, MD, is a board-certified urologist and robotic surgeon at… $430,781
Memorial Sloan-Kettering Cancer Center Scope of Work: Enrollment Center R01CA259173 Pelvic fascia spARing radical prostatectomy TrIAL (PARTIAL) The subrecipient institution will be an enrollment site… $20,085
City Of Hackensack Scope of Work: Enrollment Center R01CA259173 Pelvic fascia spARing radical prostatectomy TrIAL (PARTIAL) The subrecipient institution will be an enrollment site… $500
Sloan-Kettering Institute For Cancer Research This Statement of Work is for Dr. Andrew Vickers at Memorial Sloan Kettering Cancer Center (MSK) to collaborate with Dr. Hu at Cornell University on the… $161,610
Beckman Research Institute Of The City Of Hope The subrecipient institution will be an enrollment site for this study, performing the following tasks: randomize men to pelvic fascia sparing (PFS-RP) vs.… $500
Northwestern University Edward Schaeffer, MD, PhD will be a principal investigator and site lead for this project at Northwestern University. Dr. Schaeffer will oversee all aspects… $292,934

Quick answers

Who received award R01CA259173?

R01CA259173 was awarded to Weill Medical College Of Cornell University by National Cancer Institute (National Institutes of Health) on February 4, 2022.

How much is award R01CA259173 worth?

$4,517,532 has been obligated on R01CA259173.

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