Prostatic Neoplasms Castration-Resistant Malignant neoplasm of prostate
Conditions
Interventions
This will be a randomized clinical trial, phase III, conducted at the largest oncology care center in the state of Rio Grande do Norte/Brazil. Enrolled participants will be randomly assigned in a one-
s nutrition team. All patients will receive prednisone at a dose of 5 mg orally twice a day and will maintain food and medication dosing diaries, which will be reviewed by the research team for compli
oxaloacetic transaminase or aspartate aminotransferase (AST/TGO)
pyruvic transaminase or alanine aminotransferase (ALT/TGP)
serum potassium
glucose
total prostate-specific antigen (total PSA)
and serum testosterone. The sample size calculation will be established using G Power Software version 3.1.9.2, considering
Sponsors
Liga Norte Rio Grandense Contra o Câncer
Liga Norte Rio Grandense Contra o Câncer
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Male patients over 18 years old; with metastatic castration-resistant prostate cancer; previously treated with Androgen Deprivation Therapy (ADT) and chemotherapy (CT) with docetaxel; chemically or surgically castrated; patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of menor ou igual a 1; patients must be able to take the medication orally as directed and be able to fast for at least 8 hours before and at least 2 hours after taking the medication in the full dose arm; for the low-dose arm (LOW), the patient must be able to take the medication concurrently with or within 30 minutes after a conventional low-fat breakfast
Exclusion criteria
Exclusion criteria: Those who have already used abiraterone; who have not previously undergone treatment with Androgen Deprivation Therapy (ADT) and/or docetaxel; who are not chemically or surgically castrated; who have an Eastern Cooperative Oncology Group (ECOG) performance status greater than or equal to 2; who are unable to take the medication as directed according to the study arm
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome will be to observe a decline in prostate-specific antigen (PSA) of at least 50% after 12 weeks of using the medication. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary outcomes are progression-free survival, overall survival, a 50% drop in PSA, duration of response, and safety. | — |
Countries
BR
Contacts
Public ContactAna Rafaela Nascimento e Bouças
Liga Norte Rio Grandense Contra o Câncer
Outcome results
None listed