Grant Details
Grant Number: |
1R01CA242559-01A1 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: |
2020 |
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
Furthering the Capacity of Urologists to Shape the Field of Dissemination and Implementation Science and Enhance Clinical Practice.
Authors: Ellis S.D.
, Skolarus T.A.
.
Source: The Journal Of Urology, 2024-10-14 00:00:00.0; , p. 101097JU0000000000004293.
EPub date: 2024-10-14 00:00:00.0.
PMID: 39401343
Related Citations
Survival by first-line therapy and prognostic group among men with metastatic castration-resistant prostate cancer.
Authors: Caram M.E.V.
, Kumbier K.
, Tsao P.A.
, Burns J.
, Sparks J.B.
, Stensland K.D.
, Reichert Z.R.
, Alumkal J.J.
, Hollenbeck B.K.
, Shahinian V.
, et al.
.
Source: Cancer Medicine, 2024 Jun; 13(12), p. e7334.
PMID: 39143030
Related Citations
Mortality reduction and cumulative excess incidence (CEI) in the prostate-specific antigen (PSA) screening era.
Authors: McLaughlin P.W.
, Cousins M.M.
, Tsodikov A.
, Soni P.D.
, Crook J.M.
.
Source: Scientific Reports, 2024-03-09 00:00:00.0; 14(1), p. 5810.
EPub date: 2024-03-09 00:00:00.0.
PMID: 38461151
Related Citations
Determinants of Bone-Modifying Agent Prescribing for Metastatic Castration-Resistant Prostate Cancer in a National Health Care Delivery System.
Authors: Nguyen C.B.
, Kobe C.
, Kumbier K.E.
, Bauman J.
, Burns J.A.
, Tsao P.A.
, Sparks J.B.
, Skolarus T.A.
, Caram M.E.V.
.
Source: Jco Oncology Practice, 2024 Jan; 20(1), p. 59-68.
EPub date: 2023-11-02 00:00:00.0.
PMID: 38085028
Related Citations
Primary Care Physician and Urologist Perspectives on Optimizing Active Surveillance for Low-Risk Prostate Cancer.
Authors: Radhakrishnan A.
, Subramanian L.
, Rankin A.J.
, Fetters M.D.
, Wittmann D.A.
, Ginsburg K.B.
, Hawley S.T.
, Skolarus T.A.
.
Source: Annals Of Family Medicine, 2024 Jan-Feb; 22(1), p. 5-11.
PMID: 38253492
Related Citations
Efficiency of the Breslow estimator in semiparametric transformation models.
Authors: Devasia T.P.
, Tsodikov A.
.
Source: Lifetime Data Analysis, 2023-11-26 00:00:00.0; , .
EPub date: 2023-11-26 00:00:00.0.
PMID: 38007694
Related Citations
National Long-term Survival Estimates After Radical Prostatectomy for Prostate Cancer.
Authors: Stensland K.D.
, Caram M.E.V.
, Herr D.J.
, Burns J.A.
, Sparks J.B.
, Elliott D.A.
, Shin C.
, Morgan T.M.
, Zaslavsky A.
, Hollenbeck B.K.
, et al.
.
Source: Urology, 2023-11-10 00:00:00.0; , .
EPub date: 2023-11-10 00:00:00.0.
PMID: 37951360
Related Citations
Mental health care utilization among men with castration-resistant prostate cancer receiving abiraterone or enzalutamide.
Authors: Tsao P.A.
, Burns J.
, Kumbier K.
, Sparks J.B.
, Entenman S.
, Bloor L.E.
, Bohnert A.S.B.
, Skolarus T.A.
, Caram M.E.V.
.
Source: Cancer Medicine, 2023 Aug; 12(15), p. 16490-16501.
EPub date: 2023-06-16 00:00:00.0.
PMID: 37325888
Related Citations
Outcomes after definitive radiation therapy for localized prostate cancer in a national health care delivery system.
Authors: Herr D.J.
, Elliott D.A.
, Duchesne G.
, Stensland K.D.
, Caram M.E.V.
, Chapman C.
, Burns J.A.
, Hollenbeck B.K.
, Sparks J.B.
, Shin C.
, et al.
.
Source: Cancer, 2023-06-30 00:00:00.0; , .
EPub date: 2023-06-30 00:00:00.0.
PMID: 37389814
Related Citations
Understanding the Role of Urology Practice Organization and Racial Composition in Prostate Cancer Treatment Disparities.
Authors: Agochukwu-Mmonu N.
, Qin Y.
, Kaufman S.
, Oerline M.
, Vince R.
, Makarov D.
, Caram M.V.
, Chapman C.
, Ravenell J.
, Hollenbeck B.K.
, et al.
.
Source: Jco Oncology Practice, 2023 May; 19(5), p. e763-e772.
EPub date: 2023-01-19 00:00:00.0.
PMID: 36657098
Related Citations
Differential adoption of castration-resistant prostate cancer treatment across facilities in a national healthcare system.
Authors: Caram M.E.V.
, Kumbier K.
, Burns J.
, Sparks J.B.
, Tsao P.A.
, Stensland K.D.
, Washington S.L.
, Hollenbeck B.K.
, Shahinian V.
, Skolarus T.A.
.
Source: Cancer Medicine, 2023-02-15 00:00:00.0; , .
EPub date: 2023-02-15 00:00:00.0.
PMID: 36790037
Related Citations
Guidelines for Sexual Health Care for Prostate Cancer Patients: Recommendations of an International Panel.
Authors: Wittmann D.
, Mehta A.
, McCaughan E.
, Faraday M.
, Duby A.
, Matthew A.
, Incrocci L.
, Burnett A.
, Nelson C.J.
, Elliott S.
, et al.
.
Source: The Journal Of Sexual Medicine, 2022 Nov; 19(11), p. 1655-1669.
EPub date: 2022-10-01 00:00:00.0.
PMID: 36192299
Related Citations
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 00:00:00.0; 3(1), p. 109.
EPub date: 2022-10-10 00:00:00.0.
PMID: 36217172
Related Citations
Improving Guideline Adherence in Urology.
Authors: MacLennan S.
, Duncan E.
, Skolarus T.A.
, Roobol M.J.
, Kasivisvanathan V.
, Gallagher K.
, Gandaglia G.
, Sakalis V.
, Smith E.J.
, Plass K.
, et al.
.
Source: European Urology Focus, 2022 Sep; 8(5), p. 1545-1552.
EPub date: 2021-10-24 00:00:00.0.
PMID: 34702647
Related Citations
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 09; 208(3), p. 600-608.
EPub date: 2022-05-06 00:00:00.0.
PMID: 35522191
Related Citations
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 00:00:00.0; 6(3), .
PMID: 35616109
Related Citations
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 00:00:00.0.
PMID: 34861316
Related Citations
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 02; 18(2), p. e284-e292.
EPub date: 2021-09-07 00:00:00.0.
PMID: 34491783
Related Citations
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 00:00:00.0; , .
EPub date: 2022-01-10 00:00:00.0.
PMID: 35001083
Related Citations
Understanding Active Surveillance for Prostate Cancer.
Authors: Lai L.Y.
, Shahinian V.B.
, Oerline M.K.
, Kaufman S.R.
, Skolarus T.A.
, Caram M.E.V.
, Hollenbeck B.K.
.
Source: Jco Oncology Practice, 2021 Nov; 17(11), p. e1678-e1687.
EPub date: 2021-04-08 00:00:00.0.
PMID: 33830822
Related Citations
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 00:00:00.0; 2(1), p. 124.
EPub date: 2021-10-28 00:00:00.0.
PMID: 34711274
Related Citations
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, 2021-10-19 00:00:00.0; 111, p. 106600.
EPub date: 2021-10-19 00:00:00.0.
PMID: 34673273
Related Citations
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 10; 39(10), p. 738-739.
EPub date: 2021-08-13 00:00:00.0.
PMID: 34400067
Related Citations
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 00:00:00.0.
PMID: 34139251
Related Citations
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, 2021-05-11 00:00:00.0; , .
EPub date: 2021-05-11 00:00:00.0.
PMID: 33974197
Related Citations
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, 2021-03-25 00:00:00.0; , .
EPub date: 2021-03-25 00:00:00.0.
PMID: 33764537
Related Citations
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, 2021-02-19 00:00:00.0; , .
EPub date: 2021-02-19 00:00:00.0.
PMID: 33610652
Related Citations
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 11; 78(5), p. 731-742.
EPub date: 2020-09-04 00:00:00.0.
PMID: 32893062
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