Advances in Therapy

, Volume 30, Issue 12, pp 1041–1066 | Cite as

Evolution of the Treatment Paradigm for Patients with Metastatic Castration-Resistant Prostate Cancer

  • Zafar Malik
  • Heather Payne
  • Jawaher Ansari
  • Simon Chowdhury
  • Mohammad Butt
  • Alison Birtle
  • Santhanam Sundar
  • Chinnamani Vee Eswar
  • Simon Hughes
  • Amit Bahl
Review

Abstract

As recently as 2004, treatment options for men with metastatic castration-resistant prostate cancer (mCRPC) were limited, with docetaxel the only approved agent conferring a survival benefit. The therapeutic landscape is now very different, with several agents demonstrating prolonged survival since 2010. New agents for the treatment of mCRPC include sipuleucel-T, cabazitaxel, abiraterone acetate, enzalutamide and radium-223. All are now approved for use in this patient group, although the specific licensing terms vary between agents. In addition, denosumab may have utility in patients with bone metastases. A number of novel agents are also in development with promising initial results. However, because these treatment options have proliferated rapidly, there is currently a paucity of clinical evidence regarding their optimal sequencing. Selection of an appropriate treatment option should take into consideration disease characteristics, drug availability and patient choice. In summary, we discuss several new treatment options available for mCRPC and their integration into the current treatment paradigm.

Keywords

Abiraterone acetate Cabazitaxel Enzalutamide Radium-223 Metastatic castration-resistant prostate cancer Oncology Sipuleucel-T Treatment sequencing 

Supplementary material

12325_2013_70_MOESM1_ESM.pdf (193 kb)
Supplementary material (PDF 193 kb)

References

  1. 1.
    Jemal A, Bray F, Center MM, Ferlay J, Ward E, Forman D. Global cancer statistics. CA Cancer J Clin. 2011;61:69–90.CrossRefPubMedGoogle Scholar
  2. 2.
    Denmeade SR, Isaacs JT. A history of prostate cancer treatment. Nat Rev Cancer. 2002;2:389–96.CrossRefPubMedGoogle Scholar
  3. 3.
    National Comprehensive Cancer Network. The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines™) Prostate Cancer (Version 4.2013). 2013. http://www.nccn.org/professionals/physician_gls/pdf/prostate.pdf. Accessed 12 Sept 2013.
  4. 4.
    Horwich A, Parker C, Bangma C, Kataja V. Prostate cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2010;21(Suppl 5):v129–33.CrossRefPubMedGoogle Scholar
  5. 5.
    Scott WW, Johnson DE, Schmidt JE, et al. Chemotherapy of advanced prostatic carcinoma with cyclophosphamide or 5-fluorouracil: results of first national randomized study. J Urol. 1975;114:909–11.PubMedGoogle Scholar
  6. 6.
    George DJ, Kantoff PW, Lin DW. Clinical roundtable monograph: new and emerging treatments for advanced prostate cancer. Clin Adv Hematol Oncol. 2011;9:1–11.Google Scholar
  7. 7.
    Tannock IF, de Wit R, Berry WR, et al. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer. N Engl J Med. 2004;351:1502–12.CrossRefPubMedGoogle Scholar
  8. 8.
    Berthold DR, Pond GR, Soban F, de Wit R, Eisenberger M, Tannock IF. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer: updated survival in the TAX 327 study. J Clin Oncol. 2008;26:242–5.CrossRefPubMedGoogle Scholar
  9. 9.
    Petrylak DP, Tangen CM, Hussain MH, et al. Docetaxel and estramustine compared with mitoxantrone and prednisone for advanced refractory prostate cancer. N Engl J Med. 2004;351:1513–20.CrossRefPubMedGoogle Scholar
  10. 10.
    Heidenreich A, Bastian PJ, Bellmunt J, et al. Guidelines on prostate cancer. 2013. http://www.uroweb.org/guidelines/online-guidelines/. Accessed 21 Oct 2013.
  11. 11.
    Caffo O, Sava T, Comploj E, et al. Impact of docetaxel-based chemotherapy on quality of life of patients with castration-resistant prostate cancer: results from a prospective phase II randomized trial. BJU Int. 2011;108:1825–32.CrossRefPubMedGoogle Scholar
  12. 12.
    O’Neill AJ, Prencipe M, Dowling C, et al. Characterisation and manipulation of docetaxel resistant prostate cancer cell lines. Mol Cancer. 2011;10:126.PubMedCentralCrossRefPubMedGoogle Scholar
  13. 13.
    Dumontet C, Sikic BI. Mechanisms of action of and resistance to antitubulin agents: microtubule dynamics, drug transport, and cell death. J Clin Oncol. 1999;17:1061–70.PubMedGoogle Scholar
  14. 14.
    Shah RB, Mehra R, Chinnaiyan AM, et al. Androgen-independent prostate cancer is a heterogeneous group of diseases: lessons from a rapid autopsy program. Cancer Res. 2004;64:9209–16.CrossRefPubMedGoogle Scholar
  15. 15.
    Mita AC, Denis LJ, Rowinsky EK, et al. Phase I and pharmacokinetic study of XRP6258 (RPR 116258A), a novel taxane, administered as a 1-hour infusion every 3 weeks in patients with advanced solid tumors. Clin Cancer Res. 2009;15:723–30.CrossRefPubMedGoogle Scholar
  16. 16.
    Cisternino S, Bourasset F, Archimbaud Y, Semiond D, Sanderink G, Scherrmann JM. Nonlinear accumulation in the brain of the new taxoid TXD258 following saturation of P-glycoprotein at the blood-brain barrier in mice and rats. Br J Pharmacol. 2003;138:1367–75.PubMedCentralCrossRefPubMedGoogle Scholar
  17. 17.
    Villanueva C, Awada A, Campone M, et al. A multicentre dose-escalating study of cabazitaxel (XRP6258) in combination with capecitabine in patients with metastatic breast cancer progressing after anthracycline and taxane treatment: a phase I/II study. Eur J Cancer. 2011;47:1037–45.CrossRefPubMedGoogle Scholar
  18. 18.
    Fumoleau P, Trigo J, Campone M, et al. Phase I and pharmacokinetics (PK) study of RPR116258A given as a weekly 1-hour infusion at day 1, day 8, day 15 and day 22 every 5 weeks in patients (PTS) with advanced solid tumors. In: AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, 29 October–2 November, 2001. Miami, FL, USA.Google Scholar
  19. 19.
    Diéras V, Lortholary A, Laurence V, et al. Cabazitaxel in patients with advanced solid tumours: results of a Phase I and pharmacokinetic study. Eur J Cancer. 2013;49:25–34.CrossRefPubMedGoogle Scholar
  20. 20.
    de Bono JS, Oudard S, Ozguroglu M, et al. Prednisone plus cabazitaxel or mitoxantrone for metastatic castration-resistant prostate cancer progressing after docetaxel treatment: a randomised open-label trial. Lancet. 2010;376:1147–54.CrossRefPubMedGoogle Scholar
  21. 21.
    Oudard S. TROPIC: Phase III trial of cabazitaxel for the treatment of metastatic castration-resistant prostate cancer. Future Oncol. 2011;7:497–506.CrossRefPubMedGoogle Scholar
  22. 22.
    JEVTANA® (cabazitaxel) Injection [Prescribing Information]: Bridgewater: Sanofi U.S. LLC; 2010. http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/201023lbl.pdf. Accessed 12 Sept 2013.
  23. 23.
    Ozguroglu M, Oudard S, Sartor AO, et al. Effect of G-CSF prophylaxis on the occurrence of neutropenia in men receiving cabazitaxel plus prednisone for the treatment of metastatic castration-resistant prostate cancer (mCRPC) in the TROPIC study. J Clin Oncol. 2011;29 Suppl 7:Abstract 144.Google Scholar
  24. 24.
    Smith TJ, Khatcheressian J, Lyman GH, et al. 2006 update of recommendations for the use of white blood cell growth factors: an evidence-based clinical practice guideline. J Clin Oncol. 2006;24:3187–205.CrossRefPubMedGoogle Scholar
  25. 25.
    JEVTANA® (cabazitaxel) Injection [Summary of Product Characteristics]. Paris: Sanofi; 2013. http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002018/human_med_001428.jsp&mid=WC0b01ac058001d124. Accessed 12 Sept 2013.
  26. 26.
    ClinicalTrials.gov [Web site]. Cabazitaxel at 20 mg/m2 compared to 25 mg/m2 with prednisone for the treatment of metastatic castration resistant prostate cancer (PROSELICA). 2013. http://www.clinicaltrials.gov/show/NCT01308580. Accessed 12 Sept 2013.
  27. 27.
    ClinicalTrials.gov [Web site]. Early access to cabazitaxel in patients with metastatic hormone refractory prostate cancer previously treated with a docetaxel-containing regimen. 2013. http://www.clinicaltrials.gov/show/NCT01254279. Accessed 12 Sept 2013.
  28. 28.
    Malik Z, di Lorenzo G, Basaran M, et al. Cabazitaxel (cbz) + prednisone (P; CbzP) in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) previously treated with docetaxel (D): interim results from compassionate-use programme (CUP) and early-access programme (EAP). Ann Oncol. 2012;23:Abstract 931P.Google Scholar
  29. 29.
    Bracarda S, di Lorenzo G, Gaspamo D, et al. Preliminary safety results of an Italian early-access program (EAP) with cabazitaxel plus prednisone in patients with docetaxel-refractory metastatic castration-resistant prostate cancer (mCRPC). J Clin Oncol. 2012;30 Suppl 5:Abstract 253.Google Scholar
  30. 30.
    Bahl A, Masson S, Malik Z, et al. Cabazitaxel for metastatic castration-resistant prostate cancer (mCRPC): Interim safety and quality-of-life (QOL) data from the U.K. early access programme (NCT01254279). European Association of Urology Congress, 24–28 February 2012. Paris, France. Abstract 129.Google Scholar
  31. 31.
    Heidenreich A, Scholz HJ, Rogenhofer S, et al. Cabazitaxel plus prednisone for metastatic castration-resistant prostate cancer progressing after docetaxel: results from the German compassionate-use programme. Eur Urol. 2013;63:977–82.CrossRefPubMedGoogle Scholar
  32. 32.
    de Bono JS, Oudard S, Ozguroglu M, et al. A subgroup analysis of the TROPIC trial exploring reason for discontinuation of prior docetaxel and survival outcome of cabazitaxel in metastatic castration-resistant prostate cancer (mCRPC). J Clin Oncol. 2011;29 Suppl:Abstract 4526.Google Scholar
  33. 33.
    Attar RM, Takimoto CH, Gottardis MM. Castration-resistant prostate cancer: locking up the molecular escape routes. Clin Cancer Res. 2009;15:3251–5.CrossRefPubMedGoogle Scholar
  34. 34.
    Montgomery RB, Mostaghel EA, Vessella R, et al. Maintenance of intratumoral androgens in metastatic prostate cancer: a mechanism for castration-resistant tumor growth. Cancer Res. 2008;68:4447–54.PubMedCentralCrossRefPubMedGoogle Scholar
  35. 35.
    Attard G, Cooper CS, de Bono JS. Steroid hormone receptors in prostate cancer: a hard habit to break? Cancer Cell. 2009;16:458–62.CrossRefPubMedGoogle Scholar
  36. 36.
    Attard G, Reid AH, A’Hern R, et al. Selective inhibition of CYP17 with abiraterone acetate is highly active in the treatment of castration-resistant prostate cancer. J Clin Oncol. 2009;27:3742–8.PubMedCentralCrossRefPubMedGoogle Scholar
  37. 37.
    Mohler JL, Gregory CW, Ford OH III, et al. The androgen axis in recurrent prostate cancer. Clin Cancer Res. 2004;10:440–8.CrossRefPubMedGoogle Scholar
  38. 38.
    Attard G, Reid AH, Yap TA, et al. Phase I clinical trial of a selective inhibitor of CYP17, abiraterone acetate, confirms that castration-resistant prostate cancer commonly remains hormone driven. J Clin Oncol. 2008;26:4563–71.CrossRefPubMedGoogle Scholar
  39. 39.
    Danila DC, Morris MJ, de Bono JS, et al. Phase II multicenter study of abiraterone acetate plus prednisone therapy in patients with docetaxel-treated castration-resistant prostate cancer. J Clin Oncol. 2010;28:1496–501.PubMedCentralCrossRefPubMedGoogle Scholar
  40. 40.
    Reid AH, Attard G, Danila DC, et al. Significant and sustained antitumor activity in post-docetaxel, castration-resistant prostate cancer with the CYP17 inhibitor abiraterone acetate. J Clin Oncol. 2010;28:1489–95.PubMedCentralCrossRefPubMedGoogle Scholar
  41. 41.
    de Bono JS, Logothetis CJ, Molina A, et al. Abiraterone and increased survival in metastatic prostate cancer. N Engl J Med. 2011;364:1995–2005.PubMedCentralCrossRefPubMedGoogle Scholar
  42. 42.
    Fizazi K, Scher HI, Molina A, et al. Abiraterone acetate for treatment of metastatic castration-resistant prostate cancer: final overall survival analysis of the COU-AA-301 randomised, double-blind, placebo-controlled phase 3 study. Lancet Oncol. 2012;13:983–92.CrossRefPubMedGoogle Scholar
  43. 43.
    Ryan CJ, Smith MR, de Bono JS, et al. Abiraterone in metastatic prostate cancer without previous chemotherapy. N Engl J Med. 2013;368:138–48.CrossRefPubMedGoogle Scholar
  44. 44.
    Zytiga (abiraterone acetate) Tablets for Oral Administration [Summary of Product Characteristics]. Beerse: Janssen-Cilag International NV; 2011. http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002321/human_med_001499.jsp&mid=WC0b01ac058001d124. Accessed 12 Sept 2013.
  45. 45.
    Tran C, Ouk S, Clegg NJ, et al. Development of a second-generation antiandrogen for treatment of advanced prostate cancer. Science. 2009;324:787–90.PubMedCentralCrossRefPubMedGoogle Scholar
  46. 46.
    Scher HI, Fizazi K, Saad F, et al. Increased survival with enzalutamide in prostate cancer after chemotherapy. N Engl J Med. 2012;367:1187–97.CrossRefPubMedGoogle Scholar
  47. 47.
    XTANDI® (enzalutamide) Capsules for Oral Use [Prescribing Information]. Silver Spring: Astellas Pharma US, Inc; 2012. http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203415lbl.pdf. Accessed 12 Sept 2013.
  48. 48.
    Boyle WJ, Simonet WS, Lacey DL. Osteoclast differentiation and activation. Nature. 2003;423:337–42.CrossRefPubMedGoogle Scholar
  49. 49.
    Fizazi K, Carducci M, Smith M, et al. Denosumab versus zoledronic acid for treatment of bone metastases in men with castration-resistant prostate cancer: a randomised, double-blind study. Lancet. 2011;377:813–22.PubMedCentralCrossRefPubMedGoogle Scholar
  50. 50.
    Xgeva (denosumab) Injection, for Subcutaneous Use, [Prescribing Information]. Thousand Oaks: Amgen Inc.; 2010. http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/125320s007lbl.pdf. Accessed 12 Sept 2013.
  51. 51.
    XGEVA 120 mg Solution for Injection [Summary of Product Characteristics]. Breda: Amgen Europe BV; 2011. http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002173/human_med_001463.jsp. Accessed 12 Sept 2013.
  52. 52.
    Parker C, Nilsson S, Heinrich D, et al. Alpha emitter radium-223 and survival in metastatic prostate cancer. N Engl J Med. 2013;369:213–23.CrossRefPubMedGoogle Scholar
  53. 53.
    Xofigo (radium Ra 223 dichloride) Injection, for intravenous use, [Prescribing Information]. Wayne: Bayer HealthCare Pharmaceuticals Inc.; 2013. http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203971lbl.pdf. Accessed 12 Sept 2013.
  54. 54.
    Anassi E, Ndefo UA. Sipuleucel-T (provenge) injection: the first immunotherapy agent (vaccine) for hormone-refractory prostate cancer. PT. 2011;36:197–202.Google Scholar
  55. 55.
    Kantoff PW, Higano CS, Shore ND, et al. Sipuleucel-T immunotherapy for castration-resistant prostate cancer. N Engl J Med. 2010;363:411–22.CrossRefPubMedGoogle Scholar
  56. 56.
    PROVENGE® (sipuleucel-T) Suspension for intravenous infusion [Highlights of Prescribing Information]. Seattle: Dendreon Corporation; 2010. http://www.fda.gov/downloads/BiologicsBloodVaccines/CellularGeneTherapyProducts/ApprovedProducts/UCM210031.pdf. Accessed 12 Sept 2013.
  57. 57.
  58. 58.
    Mukherji D, Pezaro CJ, Bianchini D, Zivi A, de Bono JS. Response to abiraterone acetate in the postchemotherapy setting in patients with castration-resistant prostate cancer whose disease progresses early on docetaxel. J Clin Oncol. 2012;30 Suppl 5:Abstract 17.Google Scholar

Copyright information

© Springer Healthcare 2013

Authors and Affiliations

  • Zafar Malik
    • 1
  • Heather Payne
    • 2
  • Jawaher Ansari
    • 3
  • Simon Chowdhury
    • 4
  • Mohammad Butt
    • 5
  • Alison Birtle
    • 6
  • Santhanam Sundar
    • 7
  • Chinnamani Vee Eswar
    • 1
  • Simon Hughes
    • 4
  • Amit Bahl
    • 8
  1. 1.Clatterbridge Cancer Centre NHS Foundation TrustWirralUK
  2. 2.University College London HospitalsLondonUK
  3. 3.Beatson West of Scotland Cancer CentreGlasgowUK
  4. 4.Guy’s and St Thomas’ NHS Foundation TrustLondonUK
  5. 5.Queens Centre for Oncology and HaematologyCastle Hill HospitalHullUK
  6. 6.Rosemere Cancer CentreLancashire Teaching HospitalsPrestonUK
  7. 7.Nottingham University Hospitals NHS TrustNottinghamUK
  8. 8.Bristol Haematology and Oncology CentreBristolUK

Personalised recommendations