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Grant Details

Grant Number: 5R01CA242559-03 Interpret this number
Primary Investigator: Skolarus, Ted
Organization: University Of Michigan At Ann Arbor
Project Title: Refining Castration Use for Recurrent Prostate Cancer
Fiscal Year: 2022


Abstract

Project Summary Project Background: Nearly all US men diagnosed with prostate cancer have localized disease. Most are treated, yet roughly one in three have their prostate cancer return via rising PSA levels. A common treatment for rising PSA is castration with long-acting injectable drugs termed androgen deprivation therapy (ADT). Understanding the best timing of ADT for these men is important because most do not have symptoms of recurrent cancer, yet will deal with major side effects (e.g., diabetes, osteoporosis, obesity, heart disease) in the hopes of survival benefits. However, there is limited evidence to guide castration timing and use when it comes to rising PSA levels after treatment. This results in vague guideline recommendations and widespread practice variation. Whether some men can avoid castration, its side effects, or castration-resistance without compromising survival remains unclear. Using biostatistical models informed by real-world practice variation can refine answers to these important issues. Project Objectives: This study will combine population-based cancer registry and electronic record data from a national delivery system with biostatistical modeling and randomized trial data to examine the impact of castration with ADT on progression and survival after localized prostate cancer treatment. We will take advantage of variable castration practices to identify populations of men that may and may not benefit from castration for recurrent prostate cancer. Project Methods: This clinically-relevant, high impact study has three aims. Aim 1: To examine variation in castration use after localized prostate cancer treatment. We will identify men treated for localized prostate cancer from 2005-2015 using national cancer registry data. We will characterize longitudinal castration practices with respect to timing, continuity, and clinical factors (e.g., PSA, risk group, salvage radiotherapy) using national administrative claims, pharmacy, and laboratory, as well as randomized trial data. Aim 2: To assess the impact of castration timing on prostate cancer progression. We will identify prostate cancer progression to castration-resistant disease among our population-based and randomized trial data. We will use biostatistical modeling to identify castration practices associated with the longest times to castration-resistance and survival outcomes. Aim 3: To refine populations of men most likely to benefit from castration for recurrent prostate cancer, and when. Based on our models and complementary datasets, we will propose criteria and timing for castration practices to help maximize outcomes after localized prostate cancer treatment. For some men, delaying or avoiding castration might be best, for others, earlier castration might be optimal.



Publications

Applying implementation frameworks to the clinical trial context.
Authors: Stensland K.D. , Sales A.E. , Damschroder L.J. , Skolarus T.A. .
Source: Implementation science communications, 2022-10-10; 3(1), p. 109.
EPub date: 2022-10-10.
PMID: 36217172
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Exploring Variation in the Receipt of Recommended Active Surveillance for Men with Favorable-Risk Prostate Cancer.
Authors: Radhakrishnan A. , Wallner L.P. , Skolarus T.A. , George A.K. , Rosenberg B.H. , Abrahamse P. , Hawley S.T. .
Source: The Journal of urology, 2022 Sep; 208(3), p. 600-608.
EPub date: 2022-05-06.
PMID: 35522191
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Better Understanding the Timing Of Androgen Deprivation Trial Outcomes: Impacts of Prior Androgen Deprivation Therapy.
Authors: Stensland K.D. , Devasia T. , Caram M.E.V. , Chapman C. , Zaslavsky A. , Morgan T.M. , Hollenbeck B.K. , Sparks J.B. , Burns J. , Vedapudi V. , et al. .
Source: JNCI cancer spectrum, 2022-05-02; 6(3), .
PMID: 35616109
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Promotional Payments to Medical Oncologists and Urologists and Prescriptions for Abiraterone and Enzalutamide.
Authors: Lai L.Y. , Oerline M.K. , Kaufman S.R. , Herrel L.A. , Skolarus T.A. , Dusetzina S.B. , Ellimoottil C. , Shahinian V.B. , Hollenbeck B.K. , Caram M.E.V. .
Source: Urology, 2022 Mar; 161, p. 50-58.
EPub date: 2021-12-01.
PMID: 34861316
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Characterizing Out-of-Pocket Payments and Financial Assistance for Patients Prescribed Abiraterone and Enzalutamide at an Academic Cancer Center Specialty Pharmacy.
Authors: Jeong A.Y. , Schwartz E.B. , Roman A.R. , McDevitt R.L. , Oerline M.K. , Henry E. , Veenstra C.M. , Caram M.E.V. .
Source: JCO oncology practice, 2022 Feb; 18(2), p. e284-e292.
EPub date: 2021-09-07.
PMID: 34491783
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Comparison of the treatment of men with prostate cancer between the US and England: an international population-based study.
Authors: Parry M.G. , Nossiter J. , Morris M. , Sujenthiran A. , Skolarus T.A. , Berry B. , Nathan A. , Cathcart P. , Aggarwal A. , van der Meulen J. , et al. .
Source: Prostate cancer and prostatic diseases, 2022-01-10; , .
EPub date: 2022-01-10.
PMID: 35001083
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Prostate cancer clinical trial completion: The role of geography.
Authors: Stensland K.D. , Kaffenberger S.D. , George A.K. , Morgan T.M. , Miller D.C. , Salami S.S. , Dunn R.L. , Palapattu G.S. , Montgomery J.S. , Hollenbeck B.K. , et al. .
Source: Contemporary clinical trials, 2021 Dec; 111, p. 106600.
EPub date: 2021-10-19.
PMID: 34673273
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Development and Validation of a Short Version of the Metric for the Observation of Decision-Making in Multidisciplinary Tumor Boards: MODe-Lite.
Authors: Lamb B.W. , Miah S. , Skolarus T.A. , Stewart G.D. , Green J.S.A. , Sevdalis N. , Soukup T. .
Source: Annals of surgical oncology, 2021 Nov; 28(12), p. 7577-7588.
EPub date: 2021-05-11.
PMID: 33974197
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Learning from the "tail end" of de-implementation: the case of chemical castration for localized prostate cancer.
Authors: Skolarus T.A. , Forman J. , Sparks J.B. , Metreger T. , Hawley S.T. , Caram M.V. , Dossett L. , Paniagua-Cruz A. , Makarov D.V. , Leppert J.T. , et al. .
Source: Implementation science communications, 2021-10-28; 2(1), p. 124.
EPub date: 2021-10-28.
PMID: 34711274
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Designing lean, efficient clinical trials is an ethical imperative: the fragility index should not be used in the design of randomized clinical trials.
Authors: Stensland K.D. , Daignault-Newton S. , Skolarus T.A. .
Source: Urologic oncology, 2021 Oct; 39(10), p. 738-739.
EPub date: 2021-08-13.
PMID: 34400067
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Using an Automated Electronic Health Record Score To Estimate Life Expectancy In Men Diagnosed With Prostate Cancer In The Veterans Health Administration.
Authors: Soerensen S.J.C. , Thomas I.C. , Schmidt B. , Daskivich T.J. , Skolarus T.A. , Jackson C. , Osborne T.F. , Chertow G.M. , Brooks J.D. , Rehkopf D.H. , et al. .
Source: Urology, 2021 Sep; 155, p. 70-76.
EPub date: 2021-06-15.
PMID: 34139251
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Urology Workforce Changes and Implications for Prostate Cancer Care Among Medicare Enrollees.
Authors: Marchetti K.A. , Oerline M. , Hollenbeck B.K. , Kaufman S.R. , Skolarus T.A. , Shahinian V.B. , Caram M.E.V. , Modi P.K. .
Source: Urology, 2021 Sep; 155, p. 77-82.
EPub date: 2021-02-19.
PMID: 33610652
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Factors influencing treatment of veterans with advanced prostate cancer.
Authors: Caram M.E.V. , Burns J. , Kumbier K. , Sparks J.B. , Tsao P.A. , Chapman C.H. , Bauman J. , Hollenbeck B.K. , Shahinian V.B. , Skolarus T.A. .
Source: Cancer, 2021-07-01; 127(13), p. 2311-2318.
EPub date: 2021-03-25.
PMID: 33764537
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The Impact of the COVID-19 Pandemic on Genitourinary Cancer Care: Re-envisioning the Future.
Authors: Wallis C.J.D. , Catto J.W.F. , Finelli A. , Glaser A.W. , Gore J.L. , Loeb S. , Morgan T.M. , Morgans A.K. , Mottet N. , Neal R. , et al. .
Source: European urology, 2020 Nov; 78(5), p. 731-742.
EPub date: 2020-09-04.
PMID: 32893062
Related Citations

Association between PSA values and surveillance quality after prostate cancer surgery.
Authors: Chapman C.H. , Caram M.E.V. , Radhakrishnan A. , Tsodikov A. , Deville C. , Burns J. , Zaslavsky A. , Chang M. , Leppert J.T. , Hofer T. , et al. .
Source: Cancer medicine, 2019 Dec; 8(18), p. 7903-7912.
EPub date: 2019-11-05.
PMID: 31691526
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