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

Autor: Facundo Zaffaroni, Telma Santos, Andre P. Fay, Carlos Barrios, Vinicius Carrera Souza, David Queiroz Borges Muniz, Fernando C. Maluf, Eduardo Cronemberger, Fabio Ab Schutz, Paulo Ricardo Santos Nunes Filho, Fabio A. Peixoto, Suelen Patricia dos Santos Martins, Flavio Mavignier Carcano, Gustavo Werutsky, Oren Smaletz, Daniel Herchenhorn
Rok vydání: 2019
Předmět:
Male
0301 basic medicine
Cancer Research
medicine.medical_specialty
Antineoplastic Agents
Hormonal
Abiraterone Acetate
Urology
Androgen deprivation therapy
Adenocarcinoma
lcsh:RC254-282
Disease-Free Survival
Study Protocol
03 medical and health sciences
Prostate cancer
chemistry.chemical_compound
0302 clinical medicine
Antineoplastic Combined Chemotherapy Protocols
Apalutamide
Androgen Receptor Antagonists
Genetics
medicine
Humans
Testosterone
Patient Reported Outcome Measures
Abiraterone
Castration-sensitive prostate cancer
business.industry
Standard treatment
Goserelin
Abiraterone acetate
lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens
medicine.disease
Prostatic Neoplasms
Castration-Resistant
Treatment Outcome
030104 developmental biology
Thiohydantoins
Oncology
chemistry
030220 oncology & carcinogenesis
Quality of Life
Prednisone
Hormonal therapy
business
medicine.drug
Zdroj: BMC Cancer
BMC Cancer, Vol 19, Iss 1, Pp 1-8 (2019)
ISSN: 1471-2407
Popis: 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. 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. 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. This trial was registered in ClinicalTrials.gov on October 16, 2017, under Identifier: NCT02867020.
Databáze: OpenAIRE
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