Phase 2 Study of the Safety and Antitumor Activity of Apalutamide (ARN-509), a Potent Androgen Receptor Antagonist, in the High-risk Nonmetastatic Castration-resistant Prostate Cancer Cohort

European Urology

Volumn 70, Issue 6, 2016, Pages 963-970

  Smith, Matthew R ^a   Antonarakis, Emmanuel S ^b   Ryan, Charles J ^c   Berry, William R ^d   Shore, Neal D ^e   Liu, Glenn ^f   Alumkal, Joshi J ^g   Higano, Celestia S ^h   Chow Maneval, Edna ⁱ   Bandekar, Rajesh ^j   de Boer, Carla J ^k   Yu, Margaret K ^j   Rathkopf, Dana E ^l  

^a MASSACHUSETTS GENERAL HOSPITAL CANCER CENTER   (United States)

^b JOHNS HOPKINS UNIVERSITY   (United States)

^c UNIVERSITY OF CALIFORNIA   (United States)

^d Cancer Centers of North Carolina   (United States)

^e Carolina Urologic Research Center   (United States)

^f UNIVERSITY OF WISCONSIN   (United States)

^g OREGON HEALTH AND SCIENCE UNIVERSITY   (United States)

^h UNIVERSITY OF WASHINGTON   (United States)

ⁱ Aragon Pharmaceuticals   (United States)

^j JANSSEN RESEARCH AND DEVELOPMENT   (Belgium)

^k BV   (Netherlands)

^l MEMORIAL SLOAN KETTERING CANCER CENTER   (United States)

more..

Author keywords

Antitumor activity; Apalutamide; Castration resistant prostate cancer; Safety

Indexed keywords

ABIRATERONE ACETATE; ANTINEOPLASTIC AGENT; APALUTAMIDE; BICALUTAMIDE; FLUTAMIDE; GONADORELIN; GONADORELIN ANTAGONIST; GONADORELIN DERIVATIVE; NILUTAMIDE; PROSTATE SPECIFIC ANTIGEN; ANDROGEN RECEPTOR ANTAGONIST; KALLIKREIN; KALLIKREIN-RELATED PEPTIDASE 3, HUMAN; THIOHYDANTOIN DERIVATIVE;

ABDOMINAL PAIN; ADULT; AGED; AIRWAY OBSTRUCTION; AMNESIA; ANDROGEN DEPRIVATION THERAPY; ANTIANDROGEN THERAPY; ANTINEOPLASTIC ACTIVITY; ARTHRALGIA; ARTICLE; BACKACHE; BODY WEIGHT DISORDER; BONE MARROW TUMOR; BRAIN CANCER; CANCER CHEMOTHERAPY; CANCER CONTROL; CANCER GROWTH; CANCER HORMONE THERAPY; CANCER PATIENT; CANCER PROGNOSIS; CANCER SURGERY; CASTRATION RESISTANT PROSTATE CANCER; CHRONOPHARMACOLOGY; CLINICAL EVALUATION; COHORT ANALYSIS; COLORECTAL CANCER; CONSTIPATION; CONTUSION; COUGHING; DECREASED APPETITE; DIARRHEA; DIZZINESS; DOSE RESPONSE; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG HYPERSENSITIVITY; DRUG POTENCY; DRUG SAFETY; DRUG WITHDRAWAL; DYSGEUSIA; DYSPHAGIA; EASTERN COOPERATIVE ONCOLOGY GROUP PERFORMANCE STATUS; ERYTHEMA; ESOPHAGUS CANCER; FATIGUE; FOLLOW UP; FUNCTIONAL STATUS ASSESSMENT; GLEASON SCORE; HEADACHE; HEMATURIA; HIGH RISK PATIENT; HOT FLUSH; HUMAN; HYPERTENSION; HYPOTHYROIDISM; INTERVENTION STUDY; LIMB PAIN; MACULAR RASH; MAJOR CLINICAL STUDY; MALE; MELANOMA; METASTASIS FREE SURVIVAL; MULTICENTER STUDY; NAUSEA; NERVE ROOT COMPRESSION; ORCHIECTOMY; OUTCOME ASSESSMENT; PERITONEUM ADHESION; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 2 CLINICAL TRIAL; POLLAKISURIA; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; PROSTATE CANCER WORKING GROUP 2 CRITERIA; RASH; RESPONSE EVALUATION CRITERIA IN SOLID TUMORS; RHINOPHARYNGITIS; SEIZURE; TREATMENT DURATION; TREATMENT INTERRUPTION; TREATMENT RESPONSE; UPPER RESPIRATORY TRACT INFECTION; VISUAL DISORDER; VOMITING; BLOOD; CANCER GRADING; CLINICAL TRIAL; DISEASE FREE SURVIVAL; MIDDLE AGED; PATHOLOGY; TREATMENT OUTCOME; VERY ELDERLY;

AGED; AGED, 80 AND OVER; ANDROGEN RECEPTOR ANTAGONISTS; DISEASE-FREE SURVIVAL; HUMANS; KALLIKREINS; MALE; MIDDLE AGED; NEOPLASM GRADING; PROSTATE-SPECIFIC ANTIGEN; PROSTATIC NEOPLASMS, CASTRATION-RESISTANT; THIOHYDANTOINS; TREATMENT OUTCOME;

EID: 84965043233     PISSN: 03022838     EISSN: 18737560     Source Type: Journal    
DOI: 10.1016/j.eururo.2016.04.023     Document Type: Article

References (21)

1. [1] Chi, K.N., Bjartell, A., Dearnaley, D., et al. Castration-resistant prostate cancer: from new pathophysiology to new treatment targets. Eur Urol 56 (2009), 594–605.
2. [2] Smith, M.R., Kabbinavar, F., Saad, F., et al. Natural history of rising serum prostate-specific antigen in men with castrate nonmetastatic prostate cancer. J Clin Oncol 23 (2005), 2918–2925.
3. [3] Smith, M.R., Cook, R., Lee, K.A., Nelson, J.B., Disease and host characteristics as predictors of time to first bone metastasis and death in men with progressive castration-resistant nonmetastatic prostate cancer. Cancer 117 (2011), 2077–2085.
4. [4] Smith, M.R., Saad, F., Oudard, S., et al. Denosumab and bone metastasis-free survival in men with nonmetastatic castration-resistant prostate cancer: exploratory analyses by baseline prostate-specific antigen doubling time. J Clin Oncol 31 (2013), 3800–3806.
5. [5] NCCN clinical practice guidelines in oncology (NCCN Guidelines). Prostate cancer, v.1.2016. National Comprehensive Cancer Network Web site. http://www.nccn.org/professionals/physician_gls/pdf/prostate.pdf.
6. [6] Clegg, N.J., Wongvipat, J., Joseph, J.D., et al. ARN-509: a novel antiandrogen for prostate cancer treatment. Cancer Res 72 (2012), 1494–1503.
7. [7] Jung, M.E., Ouk, S., Yoo, D., et al. Structure-activity relationship for thiohydantoin androgen receptor antagonists for castration-resistant prostate cancer (CRPC). J Med Chem 53 (2010), 2779–2796.
8. [8] Rathkopf, D.E., Morris, M.J., Fox, J.J., et al. Phase I study of ARN-509, a novel antiandrogen, in the treatment of castration-resistant prostate cancer. J Clin Oncol 31 (2013), 3525–3530.
9. [9] Scher, H.I., Halabi, S., Tannock, I., et al. Design and end points of clinical trials for patients with progressive prostate cancer and castrate levels of testosterone: recommendations of the Prostate Cancer Clinical Trials Working Group. J Clin Oncol 26 (2008), 1148–1159.
10. [10] Therasse, P., Arbuck, S.G., Eisenhauer, E.A., et al. New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst 92 (2000), 205–216.
11. [11] Foster, W.R., Car, B.D., Shi, H., et al. Drug safety is a barrier to the discovery and development of new androgen receptor antagonists. Prostate 71 (2011), 480–488.
12. [12] Beer, T.M., Armstrong, A.J., Rathkopf, D.E., et al. Enzalutamide in metastatic prostate cancer before chemotherapy. N Engl J Med 371 (2014), 424–433.
13. [13] Penson, D.F., Armstrong, A.J., Concepcion, R., et al. Enzalutamide versus bicalutamide in castration-resistant prostate cancer: the STRIVE trial. J Clin Oncol., 2016 Jan 25 [Epub ahead of print].
14. [14] Scher, H.I., Fizazi, K., Saad, F., et al. Increased survival with enzalutamide in prostate cancer after chemotherapy. N Engl J Med 367 (2012), 1187–1197.
15. [15] Mason, M.D., Sydes, M.R., Glaholm, J., et al. Oral sodium clodronate for nonmetastatic prostate cancer–results of a randomized double-blind placebo-controlled trial: Medical Research Council PR04 (ISRCTN61384873). J Natl Cancer Inst 99 (2007), 765–776.
16. [16] Nelson, J.B., Love, W., Chin, J.L., et al. Phase 3, randomized, controlled trial of atrasentan in patients with nonmetastatic, hormone-refractory prostate cancer. Cancer 113 (2008), 2478–2487.
17. [17] Smith, M.R., Saad, F., Coleman, R., et al. Denosumab and bone-metastasis-free survival in men with castration-resistant prostate cancer: results of a phase 3, randomised, placebo-controlled trial. Lancet 379 (2012), 39–46.
18. [18] Wirth, M., Tammela, T., Cicalese, V., et al. Prevention of bone metastases in patients with high-risk nonmetastatic prostate cancer treated with zoledronic acid: efficacy and safety results of the Zometa European Study (ZEUS). Eur Urol 67 (2015), 482–491.
19. [19] Tombal B, Jassem J, Shreeve SM, et al. SPARTAN - a randomized double-blind, comparative study of ARN-509 plus androgen deprivation therapy (ADT) vs ADT alone in nonmetastatic castration-resistant prostate cancer (M0-CRPC) [abstract 806TiP]. Paper presented at: European Society for Medical Oncology (ESMO) Annual Congress; September 26-30, 2014; Madrid, Spain.
20. [20] Sternberg CN, Fizazi K, Saad F, et al. PROSPER: A phase 3 study of enzalutamide in non-metastatic (M0) castration-resistant prostate cancer (CRPC) patients [abstract 802TiP]. Paper presented at: European Society for Medical Oncology (ESMO) Annual Congress; September 26-30, 2014; Madrid, Spain.
21. [21] Efficacy and safety study of ODM-201 in men with high-risk non-metastatic castration-resistant prostate cancer (ARAMIS). ClinicalTrials.gov Web site. https://clinicaltrials.gov/ct2/show/NCT02200614. Accessed April 15, 2015.