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Clinical trial · no report yet · Phase 2

LACOG 0415

Study of Abiraterone Acetate Plus ADT Versus APALUTAMIDE Versus Abiraterone and APALUTAMIDE in Patients With Advanced Prostate Cancer With Non-castrate Testosterone Levels

We haven't built an HCP commentary report on LACOG 0415 (apalutamide; apalutamide plus abiraterone in advanced prostate cancer with non-castrate testosterone levels) yet. This page shows the registry record and the public commentary we found that names the trial. A report reads that commentary and sets out what clinicians said about the trial, each point linked to its source. How reports are made.

Indexed commentary on LACOG 0415 so far

Podcasts, YouTube videos and X posts we have indexed that name the trial. It is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this.

ChannelIndexed
X threads5

The trial

ClinicalTrials.gov
Official title
Phase II Randomized Study of Abiraterone Acetate Plus ADT Versus APALUTAMIDE Versus Abiraterone and APALUTAMIDE in Patients With Advanced Prostate Cancer With Non-castrate Testosterone Levels
Phase
Phase 2
Status
Completed
Conditions
Prostate Cancer
Interventions
Apalutamide; Abiraterone; ADT; Prednisone
Arms
  • Abiraterone acetate + Prednisone + ADT (Goserelin) · Active comparator
  • APALUTAMIDE monotherapy · Experimental
  • Abiraterone acetate + Prednisone + APALUTAMIDE · Experimental
Enrollment
128
Primary outcomes
  • Number of patients that achieves an undetectable PSA level, defined as ≤ 0.2 ng/mL
Sponsor
Latin American Cooperative Oncology Group with Janssen Pharmaceuticals
Start
Oct 11, 2017
Primary completion
Oct 9, 2019
Results posted
No
Registry record
NCT02867020 · updated Jul 7, 2021

Publications

linked from the registry
  • Hershman DL, Unger JM, Wright JD, Ramsey S, Till C, Tangen CM, Barlow WE, Blanke C, Thompson IM, Hussain M. Adverse Health Events Following Intermittent and Continuous Androgen Deprivation in Patients With Metastatic Prostate Cancer. JAMA Oncol. 2016 Apr;2(4):453-61. doi: 10.1001/jamaoncol.2015.4655. PubMed 26720308
  • Rozet F, Roumeguere T, Spahn M, Beyersdorff D, Hammerer P. Non-metastatic castrate-resistant prostate cancer: a call for improved guidance on clinical management. World J Urol. 2016 Nov;34(11):1505-1513. doi: 10.1007/s00345-016-1803-9. Epub 2016 Mar 17. PubMed 26988552
  • Crawford ED, Higano CS, Shore ND, Hussain M, Petrylak DP. Treating Patients with Metastatic Castration Resistant Prostate Cancer: A Comprehensive Review of Available Therapies. J Urol. 2015 Dec;194(6):1537-47. doi: 10.1016/j.juro.2015.06.106. Epub 2015 Jul 18. PubMed 26196735
  • Gartrell BA, Coleman R, Efstathiou E, Fizazi K, Logothetis CJ, Smith MR, Sonpavde G, Sartor O, Saad F. Metastatic Prostate Cancer and the Bone: Significance and Therapeutic Options. Eur Urol. 2015 Nov;68(5):850-8. doi: 10.1016/j.eururo.2015.06.039. Epub 2015 Jul 4. PubMed 26153564
  • Barrie SE, Potter GA, Goddard PM, Haynes BP, Dowsett M, Jarman M. Pharmacology of novel steroidal inhibitors of cytochrome P450(17) alpha (17 alpha-hydroxylase/C17-20 lyase). J Steroid Biochem Mol Biol. 1994 Sep;50(5-6):267-73. doi: 10.1016/0960-0760(94)90131-7. PubMed 7918112
  • Attard G, Reid AH, A'Hern R, Parker C, Oommen NB, Folkerd E, Messiou C, Molife LR, Maier G, Thompson E, Olmos D, Sinha R, Lee G, Dowsett M, Kaye SB, Dearnaley D, Kheoh T, Molina A, de Bono JS. Selective inhibition of CYP17 with abiraterone acetate is highly active in the treatment of castration-resistant prostate cancer. J Clin Oncol. 2009 Aug 10;27(23):3742-8. doi: 10.1200/JCO.2008.20.0642. Epub 2009 May 26. PubMed 19470933
  • Attard G, Reid AH, Yap TA, Raynaud F, Dowsett M, Settatree S, Barrett M, Parker C, Martins V, Folkerd E, Clark J, Cooper CS, Kaye SB, Dearnaley D, Lee G, de Bono JS. 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 Oct 1;26(28):4563-71. doi: 10.1200/JCO.2007.15.9749. Epub 2008 Jul 21. PubMed 18645193
  • Danila DC, Morris MJ, de Bono JS, Ryan CJ, Denmeade SR, Smith MR, Taplin ME, Bubley GJ, Kheoh T, Haqq C, Molina A, Anand A, Koscuiszka M, Larson SM, Schwartz LH, Fleisher M, Scher HI. Phase II multicenter study of abiraterone acetate plus prednisone therapy in patients with docetaxel-treated castration-resistant prostate cancer. J Clin Oncol. 2010 Mar 20;28(9):1496-501. doi: 10.1200/JCO.2009.25.9259. Epub 2010 Feb 16. PubMed 20159814
  • O'Donnell A, Judson I, Dowsett M, Raynaud F, Dearnaley D, Mason M, Harland S, Robbins A, Halbert G, Nutley B, Jarman M. Hormonal impact of the 17alpha-hydroxylase/C(17,20)-lyase inhibitor abiraterone acetate (CB7630) in patients with prostate cancer. Br J Cancer. 2004 Jun 14;90(12):2317-25. doi: 10.1038/sj.bjc.6601879. PubMed 15150570
  • Reid AH, Attard G, Danila DC, Oommen NB, Olmos D, Fong PC, Molife LR, Hunt J, Messiou C, Parker C, Dearnaley D, Swennenhuis JF, Terstappen LW, Lee G, Kheoh T, Molina A, Ryan CJ, Small E, Scher HI, de Bono JS. Significant and sustained antitumor activity in post-docetaxel, castration-resistant prostate cancer with the CYP17 inhibitor abiraterone acetate. J Clin Oncol. 2010 Mar 20;28(9):1489-95. doi: 10.1200/JCO.2009.24.6819. Epub 2010 Feb 16. PubMed 20159823
  • Ryan CJ, Shah S, Efstathiou E, Smith MR, Taplin ME, Bubley GJ, Logothetis CJ, Kheoh T, Kilian C, Haqq CM, Molina A, Small EJ. Phase II study of abiraterone acetate in chemotherapy-naive metastatic castration-resistant prostate cancer displaying bone flare discordant with serologic response. Clin Cancer Res. 2011 Jul 15;17(14):4854-61. doi: 10.1158/1078-0432.CCR-11-0815. Epub 2011 Jun 1. PubMed 21632851
  • Ryan CJ, Smith MR, Fong L, Rosenberg JE, Kantoff P, Raynaud F, Martins V, Lee G, Kheoh T, Kim J, Molina A, Small EJ. Phase I clinical trial of the CYP17 inhibitor abiraterone acetate demonstrating clinical activity in patients with castration-resistant prostate cancer who received prior ketoconazole therapy. J Clin Oncol. 2010 Mar 20;28(9):1481-8. doi: 10.1200/JCO.2009.24.1281. Epub 2010 Feb 16. PubMed 20159824
  • de Bono JS, Logothetis CJ, Molina A, Fizazi K, North S, Chu L, Chi KN, Jones RJ, Goodman OB Jr, Saad F, Staffurth JN, Mainwaring P, Harland S, Flaig TW, Hutson TE, Cheng T, Patterson H, Hainsworth JD, Ryan CJ, Sternberg CN, Ellard SL, Flechon A, Saleh M, Scholz M, Efstathiou E, Zivi A, Bianchini D, Loriot Y, Chieffo N, Kheoh T, Haqq CM, Scher HI; COU-AA-301 Investigators. Abiraterone and increased survival in metastatic prostate cancer. N Engl J Med. 2011 May 26;364(21):1995-2005. doi: 10.1056/NEJMoa1014618. PubMed 21612468
  • Fizazi K, Scher HI, Molina A, Logothetis CJ, Chi KN, Jones RJ, Staffurth JN, North S, Vogelzang NJ, Saad F, Mainwaring P, Harland S, Goodman OB Jr, Sternberg CN, Li JH, Kheoh T, Haqq CM, de Bono JS; COU-AA-301 Investigators. 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 Oct;13(10):983-92. doi: 10.1016/S1470-2045(12)70379-0. Epub 2012 Sep 18. PubMed 22995653
  • Ryan CJ, Smith MR, de Bono JS, Molina A, Logothetis CJ, de Souza P, Fizazi K, Mainwaring P, Piulats JM, Ng S, Carles J, Mulders PF, Basch E, Small EJ, Saad F, Schrijvers D, Van Poppel H, Mukherjee SD, Suttmann H, Gerritsen WR, Flaig TW, George DJ, Yu EY, Efstathiou E, Pantuck A, Winquist E, Higano CS, Taplin ME, Park Y, Kheoh T, Griffin T, Scher HI, Rathkopf DE; COU-AA-302 Investigators. Abiraterone in metastatic prostate cancer without previous chemotherapy. N Engl J Med. 2013 Jan 10;368(2):138-48. doi: 10.1056/NEJMoa1209096. Epub 2012 Dec 10. PubMed 23228172
  • Rathkopf DE, Morris MJ, Fox JJ, Danila DC, Slovin SF, Hager JH, Rix PJ, Chow Maneval E, Chen I, Gonen M, Fleisher M, Larson SM, Sawyers CL, Scher HI. Phase I study of ARN-509, a novel antiandrogen, in the treatment of castration-resistant prostate cancer. J Clin Oncol. 2013 Oct 1;31(28):3525-30. doi: 10.1200/JCO.2013.50.1684. Epub 2013 Sep 3. PubMed 24002508
  • Clegg NJ, Wongvipat J, Joseph JD, Tran C, Ouk S, Dilhas A, Chen Y, Grillot K, Bischoff ED, Cai L, Aparicio A, Dorow S, Arora V, Shao G, Qian J, Zhao H, Yang G, Cao C, Sensintaffar J, Wasielewska T, Herbert MR, Bonnefous C, Darimont B, Scher HI, Smith-Jones P, Klang M, Smith ND, De Stanchina E, Wu N, Ouerfelli O, Rix PJ, Heyman RA, Jung ME, Sawyers CL, Hager JH. ARN-509: a novel antiandrogen for prostate cancer treatment. Cancer Res. 2012 Mar 15;72(6):1494-503. doi: 10.1158/0008-5472.CAN-11-3948. Epub 2012 Jan 20. PubMed 22266222
  • Rathkopf DE, Antonarakis ES, Shore ND, et al: ARN-509 in men with metastatic castration-resistant prostate cancer (mCRPC). J Clin Oncol 31:abstr 48, 2013
  • Efstathiou E, Titus M, Wen S, Troncoso P, Hoang A, Corn P, Prokhorova I, Araujo J, Dmuchowski C, Melhem-Bertrandt A, Patil S, Logothetis CJ. Enzalutamide in Combination with Abiraterone Acetate in Bone Metastatic Castration-resistant Prostate Cancer Patients. Eur Urol Oncol. 2020 Feb;3(1):119-127. doi: 10.1016/j.euo.2019.01.008. Epub 2019 Apr 20. PubMed 31412017
  • Tombal B, Borre M, Rathenborg P, Werbrouck P, Van Poppel H, Heidenreich A, Iversen P, Braeckman J, Heracek J, Baskin-Bey E, Ouatas T, Perabo F, Phung D, Hirmand M, Smith MR. Enzalutamide monotherapy in hormone-naive prostate cancer: primary analysis of an open-label, single-arm, phase 2 study. Lancet Oncol. 2014 May;15(6):592-600. doi: 10.1016/S1470-2045(14)70129-9. Epub 2014 Apr 14. PubMed 24739897
  • Bastos DA, Soares A, Schutz FAB, Cronemberger E, de Almeida Luz M, Martins SPDS, Muniz DQB, Carcano FM, Smaletz O, Peixoto FA, Gomes AJ, Cruz FM, Franke FA, Herchenhorn D, Gidekel R, Werutsky G, Rebelatto TF, Gomes de Jesus R, Souza VC, Fay AP, Maluf FC. Androgen Receptor Pathway Inhibitor Therapy for Advanced Prostate Cancer: Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2025 Jan 2;8(1):e2454253. doi: 10.1001/jamanetworkopen.2024.54253. PubMed 39804646
  • Maluf FC, Schutz FA, Cronemberger EH, Luz MA, Martins SPS, Muniz DQB, Bastos DA, Carcano FM, Smaletz O, Soares A, Peixoto FA, Gomes AJ, Cruz FM, Franke FA, Herchenhorn D, Dos Santos TM, Fabricio VC, Gidekel R, Werutsky G, de Jesus RG, Souza VC, Fay AP. A phase 2 randomized clinical trial of abiraterone plus ADT, apalutamide, or abiraterone and apalutamide in patients with advanced prostate cancer with non-castrate testosterone levels (LACOG 0415). Eur J Cancer. 2021 Nov;158:63-71. doi: 10.1016/j.ejca.2021.08.032. Epub 2021 Oct 13. PubMed 34655838
  • Werutsky G, Maluf FC, Cronemberger EH, Carrera Souza V, Dos Santos Martins SP, Peixoto F, Smaletz O, Schutz F, Herchenhorn D, Santos T, Mavignier Carcano F, Queiroz Muniz D, Nunes Filho PRS, Zaffaroni F, Barrios C, Fay A. The LACOG-0415 phase II trial: abiraterone acetate and ADT versus apalutamide versus abiraterone acetate and apalutamide in patients with advanced prostate cancer with non-castration testosterone levels. BMC Cancer. 2019 May 23;19(1):487. doi: 10.1186/s12885-019-5709-y. PubMed 31122212
Analysis of public HCP commentary. Not medical advice and not for promotional use. Reports do not judge efficacy, estimate consensus or promote any product.
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