How is hormone therapy for prostate cancer being tested in clinical trials?


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Treatment in a clinical trial is an option for men with any stage of prostate cancer. Many questions about the best uses of hormone therapy still need to be answered. These include whether hormone therapy added to brachytherapy, a type of internal radiation therapy, can help improve survival for men with early-stage prostate cancer. Other questions include whether newer intensive hormone therapies may improve the outcome of men who are receiving surgery or radiation therapy for high-risk disease. Researchers are also testing new hormone therapies to treat castration-resistant prostate cancer. These include TAK-700 and VT-464 (28), which work in a way similar to abiraterone acetate.

Another question is the possible value of adding chemotherapy to hormone therapy as initial treatment for men with hormone-sensitive metastatic prostate cancer. Currently, chemotherapy is not used in these men until their disease progresses on hormone therapy (i.e., until it becomes hormone resistant). Early results of an NCI-sponsored trial that was conducted by two cancer cooperative groups—the Eastern Cooperative Oncology Group (ECOG) and the American College of Radiology Imaging Network (ACRIN)—suggest that men with hormone-sensitive metastatic prostate cancer who receive the chemotherapy drug docetaxel at the start of standard hormone therapy live longer than men who receive hormone therapy alone. The trial results suggested that men with the most extensive metastatic disease benefit the most from the early addition of docetaxel. A follow-up analysis will be performed to clarify the effect of this treatment on men with less extensive metastatic disease.

Information about clinical trials can be found on NCI’s website. NCI’s Cancer Information Service (CIS) can also provide information about clinical trials and help with clinical trial searches.

Where can someone find more information about drugs used in prostate cancer?

NCI’s Drug Information Summaries provide consumer-friendly information about certain drugs that are approved by the FDA to treat cancer or conditions related to cancer, including prostate cancer. For each drug, topics covered include background information, research results, possible side effects, FDA approval information, and ongoing clinical trials.

Selected References

1. Massie CE, Lynch A, Ramos-Montoya A, et al. The androgen receptor fuels prostate cancer by regulating central metabolism and biosynthesis. EMBO Journal 2011; 30(13):2719-2733. [PubMed Abstract]

2. Hååg P, Bektic J, Bartsch G, Klocker H, Eder IE. Androgen receptor down regulation by small interference RNA induces cell growth inhibition in androgen sensitive as well as in androgen independent prostate cancer cells. Journal of Steroid Biochemistry and Molecular Biology 2005; 96(3-4):251-258. [PubMed Abstract]

3. Lee RJ, Smith MR. Hormone Therapy for Prostate Cancer. In: Chabner BA, Longo DL, eds. Cancer Chemotherapy and Biotherapy: Principles and Practice. 5th ed: Wolters Kluwer: Lippincott Williams & Wilkins; 2011.

4. Rove KO, Crawford ED. Androgen annihilation as a new therapeutic paradigm in advanced prostate cancer. Current Opinion in Urology 2013; 23(3):208-213. [PubMed Abstract]

5. Kumar S, Shelley M, Harrison C, et al. Neo-adjuvant and adjuvant hormone therapy for localised and locally advanced prostate cancer. Cochrane Database of Systematic Reviews 2006(4): CD006019. [PubMed Abstract]

6. Bolla M, Van Tienhoven G, Warde P, et al. External irradiation with or without long-term androgen suppression for prostate cancer with high metastatic risk: 10-year results of an EORTC randomised study. Lancet Oncology 2010; 11(11):1066-1073. [PubMed Abstract]

7. Jones CU, Hunt D, McGowan DG, et al. Radiotherapy and short-term androgen deprivation for localized prostate cancer. New England Journal of Medicine 2011; 365(2):107-118. [PubMed Abstract]

8. Studer UE, Whelan P, Albrecht W, et al. Immediate or deferred androgen deprivation for patients with prostate cancer not suitable for local treatment with curative intent: European Organisation for Research and Treatment of Cancer (EORTC) Trial 30891. Journal of Clinical Oncology 2006; 24(12):1868-1876. [PubMed Abstract]

9. Loblaw DA, Virgo KS, Nam R, et al. Initial hormonal management of androgen-sensitive metastatic, recurrent, or progressive prostate cancer: 2006 update of an American Society of Clinical Oncology practice guideline. Journal of Clinical Oncology 2007; 25(12):1596-1605. [PubMed Abstract]

10. Immediate versus deferred treatment for advanced prostatic cancer: Initial results of the Medical Research Council Trial. The Medical Research Council Prostate Cancer Working Party Investigators Group. British Journal of Urology 1997; 79(2):235-246. [PubMed Abstract]

11. Studer UE, Hauri D, Hanselmann S, et al. Immediate versus deferred hormonal treatment for patients with prostate cancer who are not suitable for curative local treatment: Results of the randomized trial SAKK 08/88. Journal of Clinical Oncology 2004; 22(20):4109-4118. [PubMed Abstract]

12. Devlin HL, Mudryj M. Progression of prostate cancer: Multiple pathways to androgen independence. Cancer Letters 2009; 274(2):177-186. [PubMed Abstract]

13. Schröder FH. Progress in understanding androgen-independent prostate cancer (AIPC): A review of potential endocrine-mediated mechanisms. European Urology 2008; 53(6):1129-1137. [PubMed Abstract]

14. Zelefsky MJ, Eastham JA, Sartor AO. Castration-Resistant Prostate Cancer. In: Vincent T. DeVita J, Lawrence TS, Rosenberg SA, eds. DeVita, Hellman, and Rosenberg’s Cancer: Principles & Practice of Oncology, 9e. Philadelphia, PA: Lippincott Williams & Wilkins; 2011.

15. Fizazi K, Scher HI, Molina A, et al. Abiraterone acetate for treatment of metastatic castration-resistant prostate. Lancet Oncology 2012; 13(10):983-992. [PubMed Abstract]

16. Scher HI, Fizazi K, Saad F, et al. Increased survival with enzalutamide in prostate cancer after chemotherapy. New England Journal of Medicine 2012; 367(13):1187-1197. [PubMed Abstract]

17. Beer TM, Armstrong AJ, Rathkopf DE, et al. Enzalutamide in metastatic prostate cancer before chemotherapy. New England Journal of Medicine 2014; First published online: June 1, 2014. doi: 10.1056/NEJMoa1405095

18. Ryan CJ, Smith MR, Fizazi K, et al. Abiraterone acetate plus prednisone versus placebo plus prednisone in chemotherapy-naive men with metastatic castration-resistant prostate cancer (COU-AA-302): Final overall survival analysis of a randomised, double-blind, placebo-controlled phase 3 study. Lancet Oncology 2015; First published online: January 16, 2015. doi: 10.1016/S1470-2045(14)71205-7

19. National Comprehensive Cancer Network. NCCN Guidelines for Patients®: Prostate Cancer. Version 1.2013 ed. Fort Washington, Pa. : National Comprehensive Cancer Network; 2013: http://www.nccn.org/patients/guidelines/prostate/index.html#1/z

20. Sanda MG, Dunn RL, Michalski J, et al. Quality of life and satisfaction with outcome among prostate-cancer survivors. New England Journal of Medicine 2008; 358(12):1250-1261. [PubMed Abstract]

21. Michaelson MD, Kaufman DS, Lee H, et al. Randomized controlled trial of annual zoledronic acid to prevent gonadotropin-releasing hormone agonist-induced bone loss in men with prostate cancer. Journal of Clinical Oncology 2007; 25(9):1038-1042. [PubMed Abstract]

22. Greenspan SL, Nelson JB, Trump DL, Resnick NM. Effect of once-weekly oral alendronate on bone loss in men receiving androgen deprivation therapy for prostate cancer: A randomized trial. Annals of Internal Medicine 2007; 146(6):416-424. [PubMed Abstract]

23. Smith MR, Egerdie B, Hernández Toriz N, et al. Denosumab in men receiving androgen-deprivation therapy for prostate cancer. New England Journal of Medicine 2009; 361(8):745-755. [PubMed Abstract]

24. Sparreboom A, Cox MC, Acharya MR, Figg WD. Herbal remedies in the United States: Potential adverse interactions with anticancer agents. Journal of Clinical Oncology 2004; 22(12):2489-2503. [PubMed Abstract]

25. Galvão DA, Taaffe DR, Spry N, Newton RU. Exercise can prevent and even reverse adverse effects of androgen suppression treatment in men with prostate cancer. Prostate Cancer and Prostatic Diseases 2007; 10(4):340-346. [PubMed Abstract]

26. Crook JM, O’Callaghan CJ, Duncan G, et al. Intermittent androgen suppression for rising PSA level after radiotherapy. New England Journal of Medicine 2012; 367(10):895-903. [PubMed Abstract]

27. Hussain M, Tangen CM, Berry DL, et al. Intermittent versus continuous androgen deprivation in prostate cancer. New England Journal of Medicine 2013; 368(14):1314-1325. [PubMed Abstract]

28. Yin L, Hu Q, Hartmann RW. Recent progress in pharmaceutical therapies for castration-resistant prostate cancer. International Journal of Molecular Sciences 2013; 14(7):13958-13978. [PubMed Abstract]

Source: National Cancer Institute.