Difference between revisions of "Prostate cancer - historical"

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=Definitive radiotherapy=
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==Radiation therapy==
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{| class="wikitable" style="float:right; margin-left: 5px;"
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|-
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|[[#top|back to top]]
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|}
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===Regimen===
 +
{| border="1" style="text-align:center;" !align="left"
 +
|'''Study'''
 +
|[[Levels_of_Evidence#Evidence|'''Evidence''']]
 +
|'''Comparator'''
 +
|[[Levels_of_Evidence#Efficacy|'''Efficacy''']]
 +
|-
 +
|[http://jco.ascopubs.org/content/15/3/1013.long Pilepich et al. 1997 (RTOG 85-31)]
 +
|style="background-color:#00CD00"|Phase III
 +
|[[Prostate_cancer#Goserelin_.26_RT|Goserelin & RT]]
 +
|style="background-color:#d73027"|Inferior DFS
 +
|-
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|[http://www.nejm.org/doi/full/10.1056/NEJM199707313370502 Bolla et al. 1997]
 +
|style="background-color:#00CD00"|Phase III
 +
|[[Prostate_cancer#Goserelin_.26_RT|Goserelin & RT]]
 +
|style="background-color:#d73027"|Inferior OS
 +
|-
 +
|[http://www.redjournal.org/article/S0360-3016(01)01579-6/abstract Pilepich et al. 2001 (RTOG 86-10)]
 +
|style="background-color:#00CD00"|Phase III
 +
|[[Prostate_cancer#Goserelin.2C_Flutamide.2C_RT|Goserelin, Flutatmide, RT]]
 +
|style="background-color:#fc8d59"|Seems to have inferior cause-specific mortality
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|-
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|rowspan=2|[http://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(05)70348-X/abstract Denham et al. 2005 (TTROG 96.01)]
 +
|rowspan=2 style="background-color:#00CD00"|Phase III
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|[[Prostate_cancer#Goserelin.2C_Flutamide.2C_RT|Goserelin & Flutatmide x 3m, RT]]
 +
|style="background-color:#d73027"|Inferior DFS
 +
|-
 +
|[[Prostate_cancer#Goserelin.2C_Flutamide.2C_RT|Goserelin & Flutatmide x 6m, RT]]
 +
|style="background-color:#fc8d59"|Seems to have inferior prostate cancer-specific survival
 +
|-
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|[http://jama.ama-assn.org/content/299/3/289.long D'Amico et al. 2008]
 +
|style="background-color:#00CD00"|Phase III
 +
|[[Prostate_cancer#Goserelin.2C_Flutamide.2C_RT|Goserelin, Flutatmide, RT]]
 +
|style="background-color:#d73027"|Inferior OS
 +
|-
 +
|[http://www.nejm.org/doi/full/10.1056/NEJMoa1012348 Jones et al. 2011]
 +
|style="background-color:#00CD00"|Phase III
 +
|[[Prostate_cancer#Goserelin.2C_Flutamide.2C_RT|Goserelin, Flutatmide, RT]]<br> [[Prostate_cancer#Leuprolide.2C_Flutamide.2C_RT|Leuprolide, Flutamide, RT]]
 +
|style="background-color:#fc8d59"|Seems to have inferior OS
 +
|-
 +
|[http://onlinelibrary.wiley.com/doi/10.1002/cncr.30093/full McPartlin et al. 2016 (PMH 9907)]
 +
|style="background-color:#00CD00"|Phase III
 +
|Bicalutamide & RT
 +
|style="background-color:#ffffbf"|Seems not superior
 +
|-
 +
|}
 +
''Demonstrated to be inferior in almost all studies; here for reference purposes only.''
 +
====Radiotherapy====
 +
===References===
 +
# Pilepich MV, Caplan R, Byhardt RW, Lawton CA, Gallagher MJ, Mesic JB, Hanks GE, Coughlin CT, Porter A, Shipley WU, Grignon D. Phase III trial of androgen suppression using goserelin in unfavorable-prognosis carcinoma of the prostate treated with definitive radiotherapy: report of Radiation Therapy Oncology Group Protocol 85-31. J Clin Oncol. 1997 Mar;15(3):1013-21. [http://jco.ascopubs.org/content/15/3/1013.long link to original article] '''contains protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/9060541 PubMed]
 +
## '''Update:''' Lawton CA, Winter K, Murray K, Machtay M, Mesic JB, Hanks GE, Coughlin CT, Pilepich MV. Updated results of the phase III Radiation Therapy Oncology Group (RTOG) trial 85-31 evaluating the potential benefit of androgen suppression following standard radiation therapy for unfavorable prognosis carcinoma of the prostate. Int J Radiat Oncol Biol Phys. 2001 Mar 15;49(4):937-46. [http://www.redjournal.org/article/S0360-3016%2800%2901516-9/fulltext link to original article] '''contains protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/11240234 PubMed]
 +
## '''Update:''' Pilepich MV, Winter K, Lawton CA, Krisch RE, Wolkov HB, Movsas B, Hug EB, Asbell SO, Grignon D. Androgen suppression adjuvant to definitive radiotherapy in prostate carcinoma--long-term results of phase III RTOG 85-31. Int J Radiat Oncol Biol Phys. 2005 Apr 1;61(5):1285-90. [http://www.redjournal.org/article/S0360-3016(04)02468-X/abstract link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/15817329 PubMed]
 +
# Bolla M, Gonzalez D, Warde P, Dubois JB, Mirimanoff RO, Storme G, Bernier J, Kuten A, Sternberg C, Gil T, Collette L, Pierart M. Improved survival in patients with locally advanced prostate cancer treated with radiotherapy and goserelin. N Engl J Med. 1997 Jul 31;337(5):295-300. [http://www.nejm.org/doi/full/10.1056/NEJM199707313370502 link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/9233866 PubMed]
 +
# Pilepich MV, Winter K, John MJ, Mesic JB, Sause W, Rubin P, Lawton C, Machtay M, Grignon D. Phase III radiation therapy oncology group (RTOG) trial 86-10 of androgen deprivation adjuvant to definitive radiotherapy in locally advanced carcinoma of the prostate. Int J Radiat Oncol Biol Phys. 2001 Aug 1;50(5):1243-52. [http://www.redjournal.org/article/S0360-3016(01)01579-6/abstract link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/11483335 PubMed]
 +
## '''Update:''' Roach M 3rd, Bae K, Speight J, Wolkov HB, Rubin P, Lee RJ, Lawton C, Valicenti R, Grignon D, Pilepich MV. Short-term neoadjuvant androgen deprivation therapy and external-beam radiotherapy for locally advanced prostate cancer: long-term results of RTOG 8610. J Clin Oncol. 2008 Feb 1;26(4):585-91. Epub 2008 Jan 2. [http://jco.ascopubs.org/content/26/4/585.long link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/18172188 PubMed]
 +
# Denham JW, Steigler A, Lamb DS, Joseph D, Mameghan H, Turner S, Matthews J, Franklin I, Atkinson C, North J, Poulsen M, Christie D, Spry NA, Tai KH, Wynne C, Duchesne G, Kovacev O, D'Este C; Trans-Tasman Radiation Oncology Group. Short-term androgen deprivation and radiotherapy for locally advanced prostate cancer: results from the Trans-Tasman Radiation Oncology Group 96.01 randomised controlled trial. Lancet Oncol. 2005 Nov;6(11):841-50. [http://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(05)70348-X/abstract link to original article] '''contains protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/16257791 PubMed]
 +
# D'Amico AV, Chen MH, Renshaw AA, Loffredo M, Kantoff PW. Androgen suppression and radiation vs radiation alone for prostate cancer: a randomized trial. JAMA. 2008 Jan 23;299(3):289-95. [http://jama.ama-assn.org/content/299/3/289.long link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/18212313 PubMed] content property of [http://hemonc.org HemOnc.org]
 +
# Jones CU, Hunt D, McGowan DG, Amin MB, Chetner MP, Bruner DW, Leibenhaut MH, Husain SM, Rotman M, Souhami L, Sandler HM, Shipley WU. Radiotherapy and short-term androgen deprivation for localized prostate cancer. N Engl J Med. 2011 Jul 14;365(2):107-18. [http://www.nejm.org/doi/full/10.1056/NEJMoa1012348 link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/21751904 PubMed]
 +
# McPartlin AJ, Glicksman R, Pintilie M, Tsuji D, Mok G, Bayley A, Chung P, Bristow RG, Gospodarowicz MK, Catton CN, Milosevic M, Warde PR. PMH 9907: Long-term outcomes of a randomized phase 3 study of short-term bicalutamide hormone therapy and dose-escalated external-beam radiation therapy for localized prostate cancer. Cancer. 2016 Aug 15;122(16):2595-603. Epub 2016 May 24. [http://onlinelibrary.wiley.com/doi/10.1002/cncr.30093/full link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/27219522 PubMed]
 +
 +
=Hormonal therapy for locally advanced or metastatic disease=
 +
 +
==Castration==
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{| class="wikitable" style="float:right; margin-left: 5px;"
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|-
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|[[#top|back to top]]
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|}
 +
===Regimen===
 +
{| border="1" style="text-align:center;" !align="left"
 +
|'''Study'''
 +
|[[Levels_of_Evidence#Evidence|'''Evidence''']]
 +
|'''Comparator'''
 +
|[[Levels_of_Evidence#Efficacy|'''Efficacy''']]
 +
|-
 +
|[https://www.ncbi.nlm.nih.gov/pubmed/1824732 Soloway et al. 1991 (Zoladex Prostate Study Group)]
 +
|style="background-color:#00CD00"|Phase III
 +
|[[Prostate_cancer#Goserelin_monotherapy_2|Goserelin]]
 +
|style="background-color:#ffffbf"|Seems not superior
 +
|-
 +
|[https://www.ncbi.nlm.nih.gov/pubmed/1828183 Kaisary et al. 1991]
 +
|style="background-color:#00CD00"|Phase III
 +
|[[Prostate_cancer#Goserelin_monotherapy_2|Goserelin]]
 +
|style="background-color:#ffffbf"|Seems not superior
 +
|-
 +
|[https://www.ncbi.nlm.nih.gov/pubmed/7678043 Janknegt et al. 1993 (International Anandron Study Group)]
 +
|style="background-color:#00CD00"|Phase III
 +
|[[Prostate_cancer#Nilutamide_.28Nilandron.29|Nilutamide & Orchiectomy]]
 +
|style="background-color:#d73027"|Inferior PFS
 +
|-
 +
|[https://www.ncbi.nlm.nih.gov/pubmed/8367920 Denis et al. 1993 (EORTC 30853)]
 +
|style="background-color:#00CD00"|Phase III
 +
|[[Prostate_cancer#Flutamide_.26_Goserelin|Flutamide & Goserelin]]
 +
|style="background-color:#fc8d59"|Seems to have inferior OS
 +
|-
 +
|[https://www.ncbi.nlm.nih.gov/pubmed/9412794 Boccon-Gibod et al. 1997]
 +
|style="background-color:#00CD00"|Phase III
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|[[Prostate_cancer#Flutamide_monotherapy|Flutamide]]
 +
|style="background-color:#ffffbf"|Seems not superior
 +
|-
 +
|[https://www.ncbi.nlm.nih.gov/pubmed/9643663 Tyrrell et al. 1998]
 +
|style="background-color:#00CD00"|Phase III
 +
|[[Prostate_cancer#Bicalutamide_monotherapy|Bicalutamide]]
 +
|style="background-color:#d3d3d3"|Not reported
 +
|-
 +
|}
 +
''Not widely used as monotherapy in the United States; included for reference purposes only.''
 +
====Surgery====
 +
 +
===References===
 +
# Soloway MS, Chodak G, Vogelzang NJ, Block NL, Schellhammer PF, Smith JA Jr, Scott M, Kennealey G, Gau TC. Zoladex versus orchiectomy in treatment of advanced prostate cancer: a randomized trial. Zoladex Prostate Study Group. Urology. 1991 Jan;37(1):46-51. [https://www.ncbi.nlm.nih.gov/pubmed/1824732 PubMed]
 +
## '''Update:''' Vogelzang NJ, Chodak GW, Soloway MS, Block NL, Schellhammer PF, Smith JA Jr, Caplan RJ, Kennealey GT. Goserelin versus orchiectomy in the treatment of advanced prostate cancer: final results of a randomized trial. Zoladex Prostate Study Group. Urology. 1995 Aug;46(2):220-6. [http://www.goldjournal.net/article/S0090-4295(99)80197-6/abstract link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/7624991 PubMed]
 +
# Kaisary AV, Tyrrell CJ, Peeling WB, Griffiths K. Comparison of LHRH analogue (Zoladex) with orchiectomy in patients with metastatic prostatic carcinoma. Br J Urol. 1991 May;67(5):502-8. [https://www.ncbi.nlm.nih.gov/pubmed/1828183 PubMed]
 +
# Janknegt RA, Abbou CC, Bartoletti R, Bernstein-Hahn L, Bracken B, Brisset JM, Da Silva FC, Chisholm G, Crawford ED, Debruyne FM et al. Orchiectomy and nilutamide or placebo as treatment of metastatic prostatic cancer in a multinational double-blind randomized trial. J Urol. 1993 Jan;149(1):77-82; discussion 83. [https://www.ncbi.nlm.nih.gov/pubmed/7678043 PubMed]
 +
## '''Update:''' Janknegt RA. Total androgen blockade with the use of orchiectomy and nilutamide (Anandron) or placebo as treatment of metastatic prostate cancer. Anandron International Study Group. Cancer. 1993 Dec 15;72(12 Suppl):3874-7. [https://www.ncbi.nlm.nih.gov/pubmed/8252507 PubMed]
 +
## '''Update:''' Dijkman GA, Janknegt RA, De Reijke TM, Debruyne FM. Long-term efficacy and safety of nilutamide plus castration in advanced prostate cancer, and the significance of early prostate specific antigen normalization. International Anandron Study Group. J Urol. 1997 Jul;158(1):160-3. [https://www.ncbi.nlm.nih.gov/pubmed/9186345 PubMed]
 +
## '''Update:''' de Reijke T, Derobert E; Anandron /Nilutamide Study Group. Prognostic factor analysis in patients with advanced prostate cancer treated by castration plus anandron or placebo: a final update. Eur Urol. 2002 Aug;42(2):139-46. [http://www.europeanurology.com/article/S0302-2838%2802%2900272-5 link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/12160584 PubMed]
 +
# Denis LJ, Carnelro de Moura JL, Bono A, Sylvester R, Whelan P, Newling D, Depauw M. Goserelin acetate and flutamide versus bilateral orchiectomy: a phase III EORTC trial (30853). EORTC GU Group and EORTC Data Center. Urology. 1993 Aug;42(2):119-29; discussion 129-30. '''contains protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/8367920 PubMed]
 +
## '''Update:''' Denis LJ, Keuppens F, Smith PH, Whelan P, de Moura JL, Newling D, Bono A, Sylvester R. Maximal androgen blockade: final analysis of EORTC phase III trial 30853. EORTC Genito-Urinary Tract Cancer Cooperative Group and the EORTC Data Center. Eur Urol. 1998;33(2):144-51. [https://www.ncbi.nlm.nih.gov/pubmed/9519355 PubMed]
 +
# Boccon-Gibod L, Fournier G, Bottet P, Marechal JM, Guiter J, Rischman P, Hubert J, Soret JY, Mangin P, Mallo C, Fraysse CE. Flutamide versus orchidectomy in the treatment of metastatic prostate carcinoma. Eur Urol. 1997;32(4):391-5. '''contains protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/9412794 PubMed]
 +
# Eisenberger MA, Blumenstein BA, Crawford ED, Miller G, McLeod DG, Loehrer PJ, Wilding G, Sears K, Culkin DJ, Thompson IM Jr, Bueschen AJ, Lowe BA. Bilateral orchiectomy with or without flutamide for metastatic prostate cancer. N Engl J Med. 1998 Oct 8;339(15):1036-42. [http://www.nejm.org/doi/full/10.1056/NEJM199810083391504 link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/9761805 PubMed]
 +
# Tyrrell CJ, Kaisary AV, Iversen P, Anderson JB, Baert L, Tammela T, Chamberlain M, Webster A, Blackledge G. A randomised comparison of 'Casodex' (bicalutamide) 150 mg monotherapy versus castration in the treatment of metastatic and locally advanced prostate cancer. Eur Urol. 1998;33(5):447-56. '''contains protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/9643663 PubMed]
 +
## '''Update:''' Iversen P, Tyrrell CJ, Kaisary AV, Anderson JB, Van Poppel H, Tammela TL, Chamberlain M, Carroll K, Melezinek I. Bicalutamide monotherapy compared with castration in patients with nonmetastatic locally advanced prostate cancer: 6.3 years of followup. J Urol. 2000 Nov;164(5):1579-82. [http://www.jurology.com/article/S0022-5347(05)67032-2/fulltext link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/11025708 PubMed]
 +
# Millikan RE, Wen S, Pagliaro LC, Brown MA, Moomey B, Do KA, Logothetis CJ. Phase III trial of androgen ablation with or without three cycles of systemic chemotherapy for advanced prostate cancer. J Clin Oncol. 2008 Dec 20;26(36):5936-42. Epub 2008 Nov 24. [http://ascopubs.org/doi/full/10.1200/JCO.2007.15.9830 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3864402/ link to PMC article] [https://www.ncbi.nlm.nih.gov/pubmed/19029421 PubMed]
  
 
=Metastatic disease=
 
=Metastatic disease=
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|[[Prostate_cancer#Radium-223_monotherapy|Radium-223]]
 
|[[Prostate_cancer#Radium-223_monotherapy|Radium-223]]
 
|style="background-color:#fee08b"|Might have inferior OS
 
|style="background-color:#fee08b"|Might have inferior OS
 +
|
 +
|-
 +
|[http://www.nejm.org/doi/full/10.1056/NEJMoa1001294 Kantoff et al. 2010 (IMPACT)]
 +
|style="background-color:#00CD00"|Phase III
 +
|[[Prostate_cancer#Sipuleucel-T_monotherapy|Sipuleucel-T]]
 +
|style="background-color:#fc8d59"|Seems to have inferior OS
 +
|
 +
|-
 +
|[http://www.nejm.org/doi/full/10.1056/NEJMoa1207506 Scher et al. 2012 (AFFIRM)]
 +
|style="background-color:#00CD00"|Phase III
 +
|[[Prostate_cancer#Enzalutamide_monotherapy|Enzalutamide]]
 +
|style="background-color:#d73027"|Inferior OS
 
|
 
|
 
|-
 
|-
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|style="background-color:#d73027"|Inferior OS
 
|style="background-color:#d73027"|Inferior OS
 
|style="background-color:#d73027"|Inferior EQ-5D score
 
|style="background-color:#d73027"|Inferior EQ-5D score
 +
|-
 +
|[http://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(14)70189-5/abstract Kwon et al. 2014 (CA184-043)]
 +
|style="background-color:#00CD00"|Phase III
 +
|Ipilimumab
 +
|style="background-color:#fee08b"|Might have inferior OS
 +
|
 +
|-
 +
|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4418931/ Beer et al. 2014 (PREVAIL)]
 +
|style="background-color:#00CD00"|Phase III
 +
|[[Prostate_cancer#Enzalutamide_monotherapy|Enzalutamide]]
 +
|style="background-color:#d73027"|Inferior OS
 +
|style="background-color:#d73027"|Worse HRQoL
 +
|-
 +
|[http://ascopubs.org/doi/full/10.1200/JCO.2016.69.1584 Beer et al. 2016]
 +
|style="background-color:#00CD00"|Phase III
 +
|Ipilimumab
 +
|style="background-color:#ffffbf"|Seems not superior
 +
|
 
|-
 
|-
 
|}
 
|}
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# Nilsson S, Franzén L, Parker C, Tyrrell C, Blom R, Tennvall J, Lennernäs B, Petersson U, Johannessen DC, Sokal M, Pigott K, Yachnin J, Garkavij M, Strang P, Harmenberg J, Bolstad B, Bruland OS. Bone-targeted radium-223 in symptomatic, hormone-refractory prostate cancer: a randomised, multicentre, placebo-controlled phase II study. Lancet Oncol. 2007 Jul;8(7):587-94. [http://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(07)70147-X/abstract link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/17544845 PubMed]
 
# Nilsson S, Franzén L, Parker C, Tyrrell C, Blom R, Tennvall J, Lennernäs B, Petersson U, Johannessen DC, Sokal M, Pigott K, Yachnin J, Garkavij M, Strang P, Harmenberg J, Bolstad B, Bruland OS. Bone-targeted radium-223 in symptomatic, hormone-refractory prostate cancer: a randomised, multicentre, placebo-controlled phase II study. Lancet Oncol. 2007 Jul;8(7):587-94. [http://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(07)70147-X/abstract link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/17544845 PubMed]
 
## '''Update:''' Nilsson S, Franzén L, Parker C, Tyrrell C, Blom R, Tennvall J, Lennernäs B, Petersson U, Johannessen DC, Sokal M, Pigott K, O'Bryan-Tear CG, Thuresson M, Bolstad B, Bruland ØS. Two-year survival follow-up of the randomized, double-blind, placebo-controlled phase II study of radium-223 chloride in patients with castration-resistant prostate cancer and bone metastases. Clin Genitourin Cancer. 2013 Mar;11(1):20-6. Epub 2012 Sep 26. [http://www.clinical-genitourinary-cancer.com/article/S1558-7673(12)00168-1/fulltext link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/23021204 PubMed]
 
## '''Update:''' Nilsson S, Franzén L, Parker C, Tyrrell C, Blom R, Tennvall J, Lennernäs B, Petersson U, Johannessen DC, Sokal M, Pigott K, O'Bryan-Tear CG, Thuresson M, Bolstad B, Bruland ØS. Two-year survival follow-up of the randomized, double-blind, placebo-controlled phase II study of radium-223 chloride in patients with castration-resistant prostate cancer and bone metastases. Clin Genitourin Cancer. 2013 Mar;11(1):20-6. Epub 2012 Sep 26. [http://www.clinical-genitourinary-cancer.com/article/S1558-7673(12)00168-1/fulltext link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/23021204 PubMed]
 +
# Kantoff PW, Higano CS, Shore ND, Berger ER, Small EJ, Penson DF, Redfern CH, Ferrari AC, Dreicer R, Sims RB, Xu Y, Frohlich MW, Schellhammer PF; IMPACT Study Investigators. Sipuleucel-T immunotherapy for castration-resistant prostate cancer. N Engl J Med. 2010 Jul 29;363(5):411-22. [http://www.nejm.org/doi/full/10.1056/NEJMoa1001294 link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/20818862 PubMed]
 +
# Scher HI, Fizazi K, Saad F, Taplin ME, Sternberg CN, Miller K, de Wit R, Mulders P, Chi KN, Shore ND, Armstrong AJ, Flaig TW, Fléchon A, Mainwaring P, Fleming M, Hainsworth JD, Hirmand M, Selby B, Seely L, de Bono JS; AFFIRM Investigators. Increased survival with enzalutamide in prostate cancer after chemotherapy. N Engl J Med. 2012 Sep 27;367(13):1187-97. Epub 2012 Aug 15. [http://www.nejm.org/doi/full/10.1056/NEJMoa1207506 link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/22894553 PubMed]
 
<!--
 
<!--
 
# Chris Parker, Sten Nilsson, Daniel Heinrich, Joe M. O'Sullivan, Sophie D. Fossa, Ales Chodacki, Pawel J. Wiechno, John P. Logue, Mihalj Seke, Anders Widmark, Dag Clement Johannessen, Peter Hoskin, David Bottomley, Robert Edward Coleman, Nicholas J. Vogelzang, C. Gillies O'Bryan-Tear, Jose E. Garcia-Vargas, Minghua Shan, A. Oliver Sartor. Updated analysis of the phase III, double-blind, randomized, multinational study of radium-223 chloride in castration-resistant prostate cancer (CRPC) patients with bone metastases (ALSYMPCA). 2012 ASCO Annual Meeting Abstract LBA4512. [http://meetinglibrary.asco.org/content/95649-114 link to abstract] [http://meetinglibrary.asco.org/content/74842 link to oral abstract session]
 
# Chris Parker, Sten Nilsson, Daniel Heinrich, Joe M. O'Sullivan, Sophie D. Fossa, Ales Chodacki, Pawel J. Wiechno, John P. Logue, Mihalj Seke, Anders Widmark, Dag Clement Johannessen, Peter Hoskin, David Bottomley, Robert Edward Coleman, Nicholas J. Vogelzang, C. Gillies O'Bryan-Tear, Jose E. Garcia-Vargas, Minghua Shan, A. Oliver Sartor. Updated analysis of the phase III, double-blind, randomized, multinational study of radium-223 chloride in castration-resistant prostate cancer (CRPC) patients with bone metastases (ALSYMPCA). 2012 ASCO Annual Meeting Abstract LBA4512. [http://meetinglibrary.asco.org/content/95649-114 link to abstract] [http://meetinglibrary.asco.org/content/74842 link to oral abstract session]
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## '''Subgroup analysis:''' Prof Peter Hoskin MD, Prof Oliver Sartor MD, Prof Joe M O'Sullivan MD, Dag Clement Johannessen MD, Svein I Helle MD, John Logue FRCR, David Bottomley FRCR, Prof Sten Nilsson MD, Prof Nicholas J Vogelzang MD, Fang Fang PhD, Mona Wahba MD, Anne-Kirsti Aksnes PhD, Christopher Parker MD. Efficacy and safety of radium-223 dichloride in patients with castration-resistant prostate cancer and symptomatic bone metastases, with or without previous docetaxel use: a prespecified subgroup analysis from the randomised, double-blind, phase 3 ALSYMPCA trial. The Lancet Oncology, Volume 15, Issue 12, Pages 1397 - 1406, November 2014. [http://www.thelancet.com/journals/lanonc/article/PIIS1470-2045%2814%2970474-7/abstract link to original article]
 
## '''Subgroup analysis:''' Prof Peter Hoskin MD, Prof Oliver Sartor MD, Prof Joe M O'Sullivan MD, Dag Clement Johannessen MD, Svein I Helle MD, John Logue FRCR, David Bottomley FRCR, Prof Sten Nilsson MD, Prof Nicholas J Vogelzang MD, Fang Fang PhD, Mona Wahba MD, Anne-Kirsti Aksnes PhD, Christopher Parker MD. Efficacy and safety of radium-223 dichloride in patients with castration-resistant prostate cancer and symptomatic bone metastases, with or without previous docetaxel use: a prespecified subgroup analysis from the randomised, double-blind, phase 3 ALSYMPCA trial. The Lancet Oncology, Volume 15, Issue 12, Pages 1397 - 1406, November 2014. [http://www.thelancet.com/journals/lanonc/article/PIIS1470-2045%2814%2970474-7/abstract link to original article]
 
## '''HRQoL analysis:''' Nilsson S, Cislo P, Sartor O, Vogelzang NJ, Coleman RE, O'Sullivan JM, Reuning-Scherer J, Shan M, Zhan L, Parker C. Patient-reported quality-of-life analysis of radium-223 dichloride from the phase III ALSYMPCA study. Ann Oncol. 2016 May;27(5):868-74. Epub 2016 Feb 23. [https://academic.oup.com/annonc/article/27/5/868/2769826 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4843190/ link to PMC article] [https://www.ncbi.nlm.nih.gov/pubmed/26912557 PubMed]
 
## '''HRQoL analysis:''' Nilsson S, Cislo P, Sartor O, Vogelzang NJ, Coleman RE, O'Sullivan JM, Reuning-Scherer J, Shan M, Zhan L, Parker C. Patient-reported quality-of-life analysis of radium-223 dichloride from the phase III ALSYMPCA study. Ann Oncol. 2016 May;27(5):868-74. Epub 2016 Feb 23. [https://academic.oup.com/annonc/article/27/5/868/2769826 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4843190/ link to PMC article] [https://www.ncbi.nlm.nih.gov/pubmed/26912557 PubMed]
 +
# Kwon ED, Drake CG, Scher HI, Fizazi K, Bossi A, van den Eertwegh AJ, Krainer M, Houede N, Santos R, Mahammedi H, Ng S, Maio M, Franke FA, Sundar S, Agarwal N, Bergman AM, Ciuleanu TE, Korbenfeld E, Sengeløv L, Hansen S, Logothetis C, Beer TM, McHenry MB, Gagnier P, Liu D, Gerritsen WR; CA184-043 Investigators. Ipilimumab versus placebo after radiotherapy in patients with metastatic castration-resistant prostate cancer that had progressed after docetaxel chemotherapy (CA184-043): a multicentre, randomised, double-blind, phase 3 trial. Lancet Oncol. 2014 Jun;15(7):700-12. Epub 2014 May 13. [http://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(14)70189-5/abstract link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4418935/ link to PMC article] [https://www.ncbi.nlm.nih.gov/pubmed/24831977 PubMed]
 +
<!-- # Beer TM, Armstrong AJ, Sternberg CN, Higano CS, Iversen P, Loriot Y, et al. Enzalutamide in men with chemotherapy-naive metastatic prostate cancer (mCRPC): Results of phase III PREVAIL study. ASCO Meeting Abstracts. 2014 February 5, 2014;32(4_suppl):LBA1. [http://abstracts.asco.org/142/AbstView_142_123836.html link to original article] '''contains verified protocol''' -->
 +
# Beer TM, Armstrong AJ, Rathkopf DE, Loriot Y, Sternberg CN, Higano CS, Iversen P, Bhattacharya S, Carles J, Chowdhury S, Davis ID, de Bono JS, Evans CP, Fizazi K, Joshua AM, Kim CS, Kimura G, Mainwaring P, Mansbach H, Miller K, Noonberg SB, Perabo F, Phung D, Saad F, Scher HI, Taplin ME, Venner PM, Tombal B; PREVAIL Investigators. Enzalutamide in metastatic prostate cancer before chemotherapy. N Engl J Med. 2014 Jul 31;371(5):424-33. Epub 2014 Jun 1. [http://www.nejm.org/doi/full/10.1056/NEJMoa1405095 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4418931/ link to PMC article] [https://www.ncbi.nlm.nih.gov/pubmed/24881730 PubMed]
 +
## '''HRQoL analysis:''' Devlin N, Herdman M, Pavesi M, Phung, Naidoo S, Beer TM, Tombal B, Loriot Y, Ivanescu C, Parli T, Balk M, Holmstrom S. Health-related quality of life effects of enzalutamide in patients with metastatic castration-resistant prostate cancer: an in-depth post hoc analysis of EQ-5D data from the PREVAIL trial. Health Qual Life Outcomes. 2017 Jun 23;15(1):130. [https://hqlo.biomedcentral.com/articles/10.1186/s12955-017-0704-y link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5481866/ link to PMC article] [https://www.ncbi.nlm.nih.gov/pubmed/28645287 PubMed]
 +
# Beer TM, Kwon ED, Drake CG, Fizazi K, Logothetis C, Gravis G, Ganju V, Polikoff J, Saad F, Humanski P, Piulats JM, Gonzalez Mella P, Ng SS, Jaeger D, Parnis FX, Franke FA, Puente J, Carvajal R, Sengeløv L, McHenry MB, Varma A, van den Eertwegh AJ, Gerritsen W. Randomized, double-blind, phase III trial of ipilimumab versus placebo in asymptomatic or minimally symptomatic patients with metastatic chemotherapy-naive castration-resistant prostate cancer. J Clin Oncol. 2017 Jan;35(1):40-47. Epub 2016 Oct 31. [http://ascopubs.org/doi/full/10.1200/JCO.2016.69.1584 link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/28034081 PubMed]
  
 
[[Category:Prostate cancer regimens]]
 
[[Category:Prostate cancer regimens]]

Revision as of 16:13, 23 December 2017

Use of this site is subject to you reading and agreeing with the terms set forth in the disclaimer. If this is your first time visiting, we suggest you read the tutorial.

The purpose of this page is to provide references to regimens that are obsolete, outdated, or of historical interest only. As a general rule, this includes the inferior arm(s) of a randomized study, unless said regimens continue to be recommended by trustworthy sources such as the NCCN Guidelines. Is there a regimen missing from this list? See the main prostate cancer page for current regimens.

12 regimens on this page
14 variants on this page


Definitive radiotherapy

Radiation therapy

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Regimen

Study Evidence Comparator Efficacy
Pilepich et al. 1997 (RTOG 85-31) Phase III Goserelin & RT Inferior DFS
Bolla et al. 1997 Phase III Goserelin & RT Inferior OS
Pilepich et al. 2001 (RTOG 86-10) Phase III Goserelin, Flutatmide, RT Seems to have inferior cause-specific mortality
Denham et al. 2005 (TTROG 96.01) Phase III Goserelin & Flutatmide x 3m, RT Inferior DFS
Goserelin & Flutatmide x 6m, RT Seems to have inferior prostate cancer-specific survival
D'Amico et al. 2008 Phase III Goserelin, Flutatmide, RT Inferior OS
Jones et al. 2011 Phase III Goserelin, Flutatmide, RT
Leuprolide, Flutamide, RT 		Seems to have inferior OS
McPartlin et al. 2016 (PMH 9907) Phase III Bicalutamide & RT Seems not superior

Demonstrated to be inferior in almost all studies; here for reference purposes only.

Radiotherapy

References

  1. Pilepich MV, Caplan R, Byhardt RW, Lawton CA, Gallagher MJ, Mesic JB, Hanks GE, Coughlin CT, Porter A, Shipley WU, Grignon D. Phase III trial of androgen suppression using goserelin in unfavorable-prognosis carcinoma of the prostate treated with definitive radiotherapy: report of Radiation Therapy Oncology Group Protocol 85-31. J Clin Oncol. 1997 Mar;15(3):1013-21. link to original article contains protocol PubMed
    1. Update: Lawton CA, Winter K, Murray K, Machtay M, Mesic JB, Hanks GE, Coughlin CT, Pilepich MV. Updated results of the phase III Radiation Therapy Oncology Group (RTOG) trial 85-31 evaluating the potential benefit of androgen suppression following standard radiation therapy for unfavorable prognosis carcinoma of the prostate. Int J Radiat Oncol Biol Phys. 2001 Mar 15;49(4):937-46. link to original article contains protocol PubMed
    2. Update: Pilepich MV, Winter K, Lawton CA, Krisch RE, Wolkov HB, Movsas B, Hug EB, Asbell SO, Grignon D. Androgen suppression adjuvant to definitive radiotherapy in prostate carcinoma--long-term results of phase III RTOG 85-31. Int J Radiat Oncol Biol Phys. 2005 Apr 1;61(5):1285-90. link to original article contains verified protocol PubMed
  2. Bolla M, Gonzalez D, Warde P, Dubois JB, Mirimanoff RO, Storme G, Bernier J, Kuten A, Sternberg C, Gil T, Collette L, Pierart M. Improved survival in patients with locally advanced prostate cancer treated with radiotherapy and goserelin. N Engl J Med. 1997 Jul 31;337(5):295-300. link to original article PubMed
  3. Pilepich MV, Winter K, John MJ, Mesic JB, Sause W, Rubin P, Lawton C, Machtay M, Grignon D. Phase III radiation therapy oncology group (RTOG) trial 86-10 of androgen deprivation adjuvant to definitive radiotherapy in locally advanced carcinoma of the prostate. Int J Radiat Oncol Biol Phys. 2001 Aug 1;50(5):1243-52. link to original article contains verified protocol PubMed
    1. Update: Roach M 3rd, Bae K, Speight J, Wolkov HB, Rubin P, Lee RJ, Lawton C, Valicenti R, Grignon D, Pilepich MV. Short-term neoadjuvant androgen deprivation therapy and external-beam radiotherapy for locally advanced prostate cancer: long-term results of RTOG 8610. J Clin Oncol. 2008 Feb 1;26(4):585-91. Epub 2008 Jan 2. link to original article contains verified protocol PubMed
  4. Denham JW, Steigler A, Lamb DS, Joseph D, Mameghan H, Turner S, Matthews J, Franklin I, Atkinson C, North J, Poulsen M, Christie D, Spry NA, Tai KH, Wynne C, Duchesne G, Kovacev O, D'Este C; Trans-Tasman Radiation Oncology Group. Short-term androgen deprivation and radiotherapy for locally advanced prostate cancer: results from the Trans-Tasman Radiation Oncology Group 96.01 randomised controlled trial. Lancet Oncol. 2005 Nov;6(11):841-50. link to original article contains protocol PubMed
  5. D'Amico AV, Chen MH, Renshaw AA, Loffredo M, Kantoff PW. Androgen suppression and radiation vs radiation alone for prostate cancer: a randomized trial. JAMA. 2008 Jan 23;299(3):289-95. link to original article PubMed content property of HemOnc.org
  6. Jones CU, Hunt D, McGowan DG, Amin MB, Chetner MP, Bruner DW, Leibenhaut MH, Husain SM, Rotman M, Souhami L, Sandler HM, Shipley WU. Radiotherapy and short-term androgen deprivation for localized prostate cancer. N Engl J Med. 2011 Jul 14;365(2):107-18. link to original article contains verified protocol PubMed
  7. McPartlin AJ, Glicksman R, Pintilie M, Tsuji D, Mok G, Bayley A, Chung P, Bristow RG, Gospodarowicz MK, Catton CN, Milosevic M, Warde PR. PMH 9907: Long-term outcomes of a randomized phase 3 study of short-term bicalutamide hormone therapy and dose-escalated external-beam radiation therapy for localized prostate cancer. Cancer. 2016 Aug 15;122(16):2595-603. Epub 2016 May 24. link to original article PubMed

Hormonal therapy for locally advanced or metastatic disease

Castration

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Regimen

Study Evidence Comparator Efficacy
Soloway et al. 1991 (Zoladex Prostate Study Group) Phase III Goserelin Seems not superior
Kaisary et al. 1991 Phase III Goserelin Seems not superior
Janknegt et al. 1993 (International Anandron Study Group) Phase III Nilutamide & Orchiectomy Inferior PFS
Denis et al. 1993 (EORTC 30853) Phase III Flutamide & Goserelin Seems to have inferior OS
Boccon-Gibod et al. 1997 Phase III Flutamide Seems not superior
Tyrrell et al. 1998 Phase III Bicalutamide Not reported

Not widely used as monotherapy in the United States; included for reference purposes only.

Surgery

References

  1. Soloway MS, Chodak G, Vogelzang NJ, Block NL, Schellhammer PF, Smith JA Jr, Scott M, Kennealey G, Gau TC. Zoladex versus orchiectomy in treatment of advanced prostate cancer: a randomized trial. Zoladex Prostate Study Group. Urology. 1991 Jan;37(1):46-51. PubMed
    1. Update: Vogelzang NJ, Chodak GW, Soloway MS, Block NL, Schellhammer PF, Smith JA Jr, Caplan RJ, Kennealey GT. Goserelin versus orchiectomy in the treatment of advanced prostate cancer: final results of a randomized trial. Zoladex Prostate Study Group. Urology. 1995 Aug;46(2):220-6. link to original article contains verified protocol PubMed
  2. Kaisary AV, Tyrrell CJ, Peeling WB, Griffiths K. Comparison of LHRH analogue (Zoladex) with orchiectomy in patients with metastatic prostatic carcinoma. Br J Urol. 1991 May;67(5):502-8. PubMed
  3. Janknegt RA, Abbou CC, Bartoletti R, Bernstein-Hahn L, Bracken B, Brisset JM, Da Silva FC, Chisholm G, Crawford ED, Debruyne FM et al. Orchiectomy and nilutamide or placebo as treatment of metastatic prostatic cancer in a multinational double-blind randomized trial. J Urol. 1993 Jan;149(1):77-82; discussion 83. PubMed
    1. Update: Janknegt RA. Total androgen blockade with the use of orchiectomy and nilutamide (Anandron) or placebo as treatment of metastatic prostate cancer. Anandron International Study Group. Cancer. 1993 Dec 15;72(12 Suppl):3874-7. PubMed
    2. Update: Dijkman GA, Janknegt RA, De Reijke TM, Debruyne FM. Long-term efficacy and safety of nilutamide plus castration in advanced prostate cancer, and the significance of early prostate specific antigen normalization. International Anandron Study Group. J Urol. 1997 Jul;158(1):160-3. PubMed
    3. Update: de Reijke T, Derobert E; Anandron /Nilutamide Study Group. Prognostic factor analysis in patients with advanced prostate cancer treated by castration plus anandron or placebo: a final update. Eur Urol. 2002 Aug;42(2):139-46. link to original article contains verified protocol PubMed
  4. Denis LJ, Carnelro de Moura JL, Bono A, Sylvester R, Whelan P, Newling D, Depauw M. Goserelin acetate and flutamide versus bilateral orchiectomy: a phase III EORTC trial (30853). EORTC GU Group and EORTC Data Center. Urology. 1993 Aug;42(2):119-29; discussion 129-30. contains protocol PubMed
    1. Update: Denis LJ, Keuppens F, Smith PH, Whelan P, de Moura JL, Newling D, Bono A, Sylvester R. Maximal androgen blockade: final analysis of EORTC phase III trial 30853. EORTC Genito-Urinary Tract Cancer Cooperative Group and the EORTC Data Center. Eur Urol. 1998;33(2):144-51. PubMed
  5. Boccon-Gibod L, Fournier G, Bottet P, Marechal JM, Guiter J, Rischman P, Hubert J, Soret JY, Mangin P, Mallo C, Fraysse CE. Flutamide versus orchidectomy in the treatment of metastatic prostate carcinoma. Eur Urol. 1997;32(4):391-5. contains protocol PubMed
  6. Eisenberger MA, Blumenstein BA, Crawford ED, Miller G, McLeod DG, Loehrer PJ, Wilding G, Sears K, Culkin DJ, Thompson IM Jr, Bueschen AJ, Lowe BA. Bilateral orchiectomy with or without flutamide for metastatic prostate cancer. N Engl J Med. 1998 Oct 8;339(15):1036-42. link to original article PubMed
  7. Tyrrell CJ, Kaisary AV, Iversen P, Anderson JB, Baert L, Tammela T, Chamberlain M, Webster A, Blackledge G. A randomised comparison of 'Casodex' (bicalutamide) 150 mg monotherapy versus castration in the treatment of metastatic and locally advanced prostate cancer. Eur Urol. 1998;33(5):447-56. contains protocol PubMed
    1. Update: Iversen P, Tyrrell CJ, Kaisary AV, Anderson JB, Van Poppel H, Tammela TL, Chamberlain M, Carroll K, Melezinek I. Bicalutamide monotherapy compared with castration in patients with nonmetastatic locally advanced prostate cancer: 6.3 years of followup. J Urol. 2000 Nov;164(5):1579-82. link to original article contains verified protocol PubMed
  8. Millikan RE, Wen S, Pagliaro LC, Brown MA, Moomey B, Do KA, Logothetis CJ. Phase III trial of androgen ablation with or without three cycles of systemic chemotherapy for advanced prostate cancer. J Clin Oncol. 2008 Dec 20;26(36):5936-42. Epub 2008 Nov 24. link to original article link to PMC article PubMed

Metastatic disease

Placebo

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Regimen

Study Evidence Comparator Efficacy Toxicity
Nilsson et al. 2007 Randomized Phase II Radium-223 Might have inferior OS
Kantoff et al. 2010 (IMPACT) Phase III Sipuleucel-T Seems to have inferior OS
Scher et al. 2012 (AFFIRM) Phase III Enzalutamide Inferior OS
Parker et al. 2013 (ALSYMPCA) Phase III Radium-223 Inferior OS Inferior EQ-5D score
Kwon et al. 2014 (CA184-043) Phase III Ipilimumab Might have inferior OS
Beer et al. 2014 (PREVAIL) Phase III Enzalutamide Inferior OS Worse HRQoL
Beer et al. 2016 Phase III Ipilimumab Seems not superior

No active antineoplastic treatment; this was the comparator arm in at least one randomized trial and is included for reference purposes, only.

References

  1. Nilsson S, Franzén L, Parker C, Tyrrell C, Blom R, Tennvall J, Lennernäs B, Petersson U, Johannessen DC, Sokal M, Pigott K, Yachnin J, Garkavij M, Strang P, Harmenberg J, Bolstad B, Bruland OS. Bone-targeted radium-223 in symptomatic, hormone-refractory prostate cancer: a randomised, multicentre, placebo-controlled phase II study. Lancet Oncol. 2007 Jul;8(7):587-94. link to original article contains verified protocol PubMed
    1. Update: Nilsson S, Franzén L, Parker C, Tyrrell C, Blom R, Tennvall J, Lennernäs B, Petersson U, Johannessen DC, Sokal M, Pigott K, O'Bryan-Tear CG, Thuresson M, Bolstad B, Bruland ØS. Two-year survival follow-up of the randomized, double-blind, placebo-controlled phase II study of radium-223 chloride in patients with castration-resistant prostate cancer and bone metastases. Clin Genitourin Cancer. 2013 Mar;11(1):20-6. Epub 2012 Sep 26. link to original article contains verified protocol PubMed
  2. Kantoff PW, Higano CS, Shore ND, Berger ER, Small EJ, Penson DF, Redfern CH, Ferrari AC, Dreicer R, Sims RB, Xu Y, Frohlich MW, Schellhammer PF; IMPACT Study Investigators. Sipuleucel-T immunotherapy for castration-resistant prostate cancer. N Engl J Med. 2010 Jul 29;363(5):411-22. link to original article contains verified protocol PubMed
  3. Scher HI, Fizazi K, Saad F, Taplin ME, Sternberg CN, Miller K, de Wit R, Mulders P, Chi KN, Shore ND, Armstrong AJ, Flaig TW, Fléchon A, Mainwaring P, Fleming M, Hainsworth JD, Hirmand M, Selby B, Seely L, de Bono JS; AFFIRM Investigators. Increased survival with enzalutamide in prostate cancer after chemotherapy. N Engl J Med. 2012 Sep 27;367(13):1187-97. Epub 2012 Aug 15. link to original article contains verified protocol PubMed
  4. Parker C, Nilsson S, Heinrich D, Helle SI, O'Sullivan JM, Fosså SD, Chodacki A, Wiechno P, Logue J, Seke M, Widmark A, Johannessen DC, Hoskin P, Bottomley D, James ND, Solberg A, Syndikus I, Kliment J, Wedel S, Boehmer S, Dall'Oglio M, Franzén L, Coleman R, Vogelzang NJ, O'Bryan-Tear CG, Staudacher K, Garcia-Vargas J, Shan M, Bruland ØS, Sartor O; ALSYMPCA Investigators. Alpha emitter radium-223 and survival in metastatic prostate cancer. N Engl J Med. 2013 Jul 18;369(3):213-23. link to original article contains verified protocol PubMed
    1. Subgroup analysis: Prof Peter Hoskin MD, Prof Oliver Sartor MD, Prof Joe M O'Sullivan MD, Dag Clement Johannessen MD, Svein I Helle MD, John Logue FRCR, David Bottomley FRCR, Prof Sten Nilsson MD, Prof Nicholas J Vogelzang MD, Fang Fang PhD, Mona Wahba MD, Anne-Kirsti Aksnes PhD, Christopher Parker MD. Efficacy and safety of radium-223 dichloride in patients with castration-resistant prostate cancer and symptomatic bone metastases, with or without previous docetaxel use: a prespecified subgroup analysis from the randomised, double-blind, phase 3 ALSYMPCA trial. The Lancet Oncology, Volume 15, Issue 12, Pages 1397 - 1406, November 2014. link to original article
    2. HRQoL analysis: Nilsson S, Cislo P, Sartor O, Vogelzang NJ, Coleman RE, O'Sullivan JM, Reuning-Scherer J, Shan M, Zhan L, Parker C. Patient-reported quality-of-life analysis of radium-223 dichloride from the phase III ALSYMPCA study. Ann Oncol. 2016 May;27(5):868-74. Epub 2016 Feb 23. link to original article link to PMC article PubMed
  5. Kwon ED, Drake CG, Scher HI, Fizazi K, Bossi A, van den Eertwegh AJ, Krainer M, Houede N, Santos R, Mahammedi H, Ng S, Maio M, Franke FA, Sundar S, Agarwal N, Bergman AM, Ciuleanu TE, Korbenfeld E, Sengeløv L, Hansen S, Logothetis C, Beer TM, McHenry MB, Gagnier P, Liu D, Gerritsen WR; CA184-043 Investigators. Ipilimumab versus placebo after radiotherapy in patients with metastatic castration-resistant prostate cancer that had progressed after docetaxel chemotherapy (CA184-043): a multicentre, randomised, double-blind, phase 3 trial. Lancet Oncol. 2014 Jun;15(7):700-12. Epub 2014 May 13. link to original article link to PMC article PubMed
  6. Beer TM, Armstrong AJ, Rathkopf DE, Loriot Y, Sternberg CN, Higano CS, Iversen P, Bhattacharya S, Carles J, Chowdhury S, Davis ID, de Bono JS, Evans CP, Fizazi K, Joshua AM, Kim CS, Kimura G, Mainwaring P, Mansbach H, Miller K, Noonberg SB, Perabo F, Phung D, Saad F, Scher HI, Taplin ME, Venner PM, Tombal B; PREVAIL Investigators. Enzalutamide in metastatic prostate cancer before chemotherapy. N Engl J Med. 2014 Jul 31;371(5):424-33. Epub 2014 Jun 1. link to original article link to PMC article PubMed
    1. HRQoL analysis: Devlin N, Herdman M, Pavesi M, Phung, Naidoo S, Beer TM, Tombal B, Loriot Y, Ivanescu C, Parli T, Balk M, Holmstrom S. Health-related quality of life effects of enzalutamide in patients with metastatic castration-resistant prostate cancer: an in-depth post hoc analysis of EQ-5D data from the PREVAIL trial. Health Qual Life Outcomes. 2017 Jun 23;15(1):130. link to original article link to PMC article PubMed
  7. Beer TM, Kwon ED, Drake CG, Fizazi K, Logothetis C, Gravis G, Ganju V, Polikoff J, Saad F, Humanski P, Piulats JM, Gonzalez Mella P, Ng SS, Jaeger D, Parnis FX, Franke FA, Puente J, Carvajal R, Sengeløv L, McHenry MB, Varma A, van den Eertwegh AJ, Gerritsen W. Randomized, double-blind, phase III trial of ipilimumab versus placebo in asymptomatic or minimally symptomatic patients with metastatic chemotherapy-naive castration-resistant prostate cancer. J Clin Oncol. 2017 Jan;35(1):40-47. Epub 2016 Oct 31. link to original article PubMed
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