CLINICAL QUANDARIES GU CANCER

CLINICAL TRIALS IN PROGRESS 6. Zhang L, Zhu F, Xie L, et al. Clinical characteristics of COVID-19-infected PANTHER TRIAL cancer patients: a retrospective case study in three hospitals within Wuhan, China. Ann Oncol. 2020;31(7):894-901. doi:10.1016/j. TITLE : Prospective Study of and within the Department of Defense annonc.2020.03.296 iN ChemoTHerapy-Naïve Clinical Trials Consortium. MEn With mCRPC Stratified by Race (PANTHER; 7. Zhang HY, Wang LW, Chen YY, et al. A INCLUSION CRITERIA: Self-reported Black NCT03098836) multicentre study of 2019 novel coronavirus or White men are eligible if they possess mCRPC disease outcomes of cancer patients in Wuhan, BACKGROUND: African American or Black disease based on RECIST 1.1 criteria with PSA China. medRxiv. Published online April 15, 2020. men are underrepresented in nearly all therapeutic greater than 2.0 ng/ml. Evidence of mCRPC in the doi:10.1101/2020.03.21.20037127 trials in advanced prostate cancer. Our recently setting of ongoing ADT should be met by at least For full reference list, visit concluded AbiRace trial (Clinicaltrials.gov 1 of these criteria: (1) absolute rise in PSA of 2.0 cancernetwork.com/COVID19_prostate NCT01940276) enrolled 50 Black and 50 white men, ng/mL or an increase or more than 25% from the revealing provocative differences in prostate- nadir; (2) minimum of 2 consecutive rising PSA specific antigen (PSA) response, progression, and levels with an interval of 1 or more weeks between adverse effect rates. each PSA level; (3) CT- or MRI-based evidence of Carril-Ajuria The PANTHER trial follows a similar format with disease progression (soft tissue, nodal, or visceral Department of Medical Oncology, Hospital men with metastatic castration-resistant prostate disease progression); or (4) at least 1 new bone Universitario 12 de Octubre, Madrid, Spain. cancer (mCRPC) stratified by race. All patients scan lesion compared with the most immediate prior receive free treatment with abiraterone acetate, radiologic studies. Patient should have adequate an ligand synthesis inhibitor, and with laboratory parameters. Prior systemic chemotherapy, Remolina-Bonilla apalutamide, an inhibitor, to immunotherapy, or treatment with abiraterone Department of Hematology and Oncology, Instituto enhance androgen-deprivation therapy (ADT). Our acetate, , apalutamide, galaterone Nacional de Ciencias Medicas y Nutrición Salvador goal is to determine if there are any race-driven (TOK-001), orteronel (TAK-700), or similar agent is Zubirán, Mexico City, Mexico. differences in the efficacy of this combination. not allowed. Patients with prior chemotherapy for The end points are radiographic progression- hormone-sensitive prostate cancer are allowed. free survival and PSA kinetics, time to nadir, and PATIENT ACCRUAL INFORMATION M. Bourlon percentage of men who achieve a PSA less than 0.1 ƒ Accrual goal: 100 Department of Hematology and Oncology, Instituto ng/mL. We will also estimate the rate of objective ƒ Percent accrued: 88% accrual completed. Nacional de Ciencias Medicas y Nutrición Salvador response and the incidence of bone flares; measure Forty-nine White and 39 Black men have been Zubirán, Mexico City, Mexico. safety and tolerability, particularly incidence enrolled so far, with 11 slots remaining. and grade of hypertension; and evaluate overall survival in Black and White men. Exploratory end STUDY SITES: A total of 8 sites are open to C. Bourlon points revolve around development and validation accrual: Duke University Medical Center, Duke Department of Hematology and Oncology, Instituto of genetic biomarkers for disease prognosis and Cancer Network, Virginia Oncology Associates, Nacional de Ciencias Medicas y Nutrición Salvador determination of treatment efficacy. Karmanos Cancer Institute, Spartanburg Veterans Zubirán, Mexico City, Mexico. PANTHER is an investigator-initiated trial, funded Administration Medical Center, University of North by Janssen (investigational new drug application Carolina Lineberger Cancer Center, Tulane University, #134175; NCT03098836). This study has opened and Chesapeake Urology Research Associates. Velasco Department of Medical Oncology, Hospital ƒ Metastatic castrate- Universitario 12 de Octubre, Madrid, Spain. resistant prostate African American 2 years cancer (CRPC) Abiraterone ƒ Adenocarcinoma of acetate OR the prostate 1000 mg po daily Disease Carretero-González ƒ No history of REGISTRATION Apalutamide progression Department of Medical Oncology, Hospital chemotherapy for STRATIFICATION CRPC 240 mg po daily Universitario 12 de Octubre, Madrid, Spain. OR ƒ Karnofsky Prednisone performance status 5 mg po bid Adverse of ≥ 70 event ƒ No evidence of White Martín-Soberón neuroendocrine ca Department of Medical Oncology, Hospital Universitario 12 de Octubre, Madrid, Spain. Co-principal investigators: Daniel George, MD Castellano 905 LaSalle Street, GSRB1 Room 3017A, Durham, NC 27710. Tel: 919-668-4615, Fax: Department of Medical Oncology, Hospital 919-668-7117, [email protected] Universitario 12 de Octubre, Madrid, Spain.

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