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Clinical Trial
. 2019 May 23;19(1):487.
doi: 10.1186/s12885-019-5709-y.

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

Gustavo Werutsky  1 , Fernando Cotait Maluf  2 , Eduardo Henrique Cronemberger  3 , Vinicius Carrera Souza  4 , Suelen Patricia Dos Santos Martins  5 , Fábio Peixoto  6 , Oren Smaletz  7 , Fábio Schutz  8 , Daniel Herchenhorn  9 , Telma Santos  10 , Flavio Mavignier Carcano  11 , David Queiroz Muniz  12 , Paulo R S Nunes Filho  13 , Facundo Zaffaroni  13 , Carlos Barrios  13 , André Fay  14
Affiliations
Clinical Trial

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

Gustavo Werutsky et al. BMC Cancer. .

Abstract

Background: Testosterone suppression is the standard treatment for advanced prostate cancer, and it is associated with side-effects that impair patients' quality of life, like sexual dysfunction, osteoporosis, weight gain, and increased cardiovascular risk. We hypothesized that abiraterone acetate with prednisone (AAP) and apalutamide, alone or in combination, can be an effective hormonal therapy also possibly decreasing castration-associated side effects.

Methods: Phase II, open-label, randomized, efficacy trial of abiraterone acetate plus prednisone (AAP) and Androgen Deprivation Therapy (ADT) versus apalutamide versus the combination of AAP (without ADT) and apalutamide. Key eligibility criteria are confirmed prostate adenocarcinoma; biochemical relapse after definitive treatment (PSA ≥ 4 ng/ml and doubling time less than 10 months, or PSA ≥ 20 ng/ml); newly diagnosed locally advanced or metastatic prostate cancer; asymptomatic to moderately symptomatic regarding bone symptoms. Patients with other histology besides adenocarcinoma or previous use of hormonal therapy or chemotherapy were excluded.

Discussion: There is an urgent need to study and validate regimens such as new hormonal agents that may add benefit to castration with an acceptable safety profile. We aim to evaluate if apalutamide in monotherapy or in combination with AAP is an effective and safety hormonal treatment that can spare patients of androgen deprivation therapy.

Trial registration: This trial was registered in ClinicalTrials.gov on October 16, 2017, under Identifier: NCT02867020.

Keywords: Abiraterone; Androgen deprivation therapy; Apalutamide; Castration-sensitive prostate cancer; Goserelin; Hormonal therapy.

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Conflict of interest statement

This study has received funding from a commercial organization. Otherwise, the authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
LACOG-0415 study design (schematic)
See this image and copyright information in PMC

References

    1. Hershman DL, Unger JM, Wright JD, Ramsey S, Till C, Tangen CM, et al. Adverse health events following intermittent and continuous androgen deprivation in patients with metastatic prostate Cancer. JAMA Oncol. 2016;2:453–461. doi: 10.1001/jamaoncol.2015.4655. - DOI - PMC - PubMed
    1. Rozet F, Roumeguère 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;34:1505–1513. doi: 10.1007/s00345-016-1803-9. - DOI - PubMed
    1. 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;194:1537–1547. doi: 10.1016/j.juro.2015.06.106. - DOI - PubMed
    1. Gartrell BA, Coleman R, Efstathiou E, Fizazi K, Logothetis CJ, Smith MR, et al. Metastatic prostate Cancer and the bone: significance and therapeutic options. Eur Urol. 2015;68:850–858. doi: 10.1016/j.eururo.2015.06.039. - DOI - PubMed
    1. 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;50:267–273. doi: 10.1016/0960-0760(94)90131-7. - DOI - PubMed

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