Health Condition 1: C60-C63- Malignant neoplasms of male genital organs
Conditions
Interventions
Intervention1: Addition of docetaxel to androgen deprivation therapy (ADT) plus abiraterone acetate and prednisone: To determine whether the addition of docetaxel to androgen deprivation therapy (ADT)
Sponsors
AIIMS NEW DELHI
Eligibility
Inclusion criteria
Inclusion criteria: a) Male patients aged 18 years or older with metastatic adenocarcinoma of the prostate, defined by one of the following: Histologic or cytologic confirmation of prostate adenocarcinoma from a biopsy of a metastatic site Or Histologic confirmation of prostate adenocarcinoma from transrectal ultrasound biopsy, radical prostatectomy, or transurethral resection of the prostate, with radiologic evidence of metastatic disease consistent with prostate cancer Or Metastatic disease typical of prostate cancer such as bone metastases, pelvic lymph nodes, or para aortic lymph nodes, along with a rising serum prostate specific antigen level greater than 20 nanogram per milliliter b) Measurable or non measurable disease according to RECIST version 1.1, including target or non target lesions c) Adequate bone marrow function, defined as: Hemoglobin at least 100 gram per liter White cell count at least 4.0 into ten to the power nine per liter Platelet count at least 100 into ten to the power nine per liter d) Adequate hepatic function, defined as: Alanine aminotransferase less than two times the upper limit of normal Total bilirubin less than 1.5 times the upper limit of normal If bilirubin is between 1.5 to 2 times the upper limit of normal, conjugated direct bilirubin must be within the normal range In the presence of liver metastases, alanine aminotransferase must be less than five times the upper limit of normal e) Adequate renal function, defined as: Calculated creatinine clearance greater than 30 milliliter per minute using the Cockcroft Gault formula f) Eastern Cooperative Oncology Group performance status 0 to 2 Patients with performance status 2 are eligible only if the decline in performance status is attributable to metastatic prostate cancer g) Study treatment should be planned and the patient must be able to start treatment within seven days of randomization h) Willingness and ability to comply with all study requirements, including treatment administration and protocol mandated assessments i) Completion of baseline health related quality of life questionnaires, unless unable due to limited literacy or visual impairment j) Provision of written informed consent prior to the performance of any study specific procedures
Exclusion criteria
Exclusion criteria: a) Histologic evidence of prostate cancer with significant sarcomatoid, spindle cell, or neuroendocrine small cell components b) Estimated life expectancy of less than 12 months c) History of another malignancy within five years prior to randomization, with the exception of: Non melanoma skin cancer Adequately treated non muscle invasive urothelial carcinoma of the bladder such as carcinoma in situ, Ta, or low grade T1 tumors d) Concurrent serious medical illness, including active or severe infection, that may compromise the patient s ability to safely undergo study procedures, including: Human immunodeficiency virus infection, unless well controlled on antiretroviral therapy that does not have clinically significant drug drug interactions with abiraterone or docetaxel e) Any psychological, familial, social, or geographical circumstance that may impair compliance with study requirements or follow up, including alcohol dependence or substance abuse f) Sexually active patients who are unwilling or unable to use medically acceptable barrier methods of contraception g) Prior androgen deprivation therapy for prostate cancer, including bilateral orchiectomy, except in the following situations: Androgen deprivation therapy initiated less than 12 weeks prior to randomization, with a stable or declining prostate specific antigen. The 12 week period is calculated from the earliest of first oral anti androgen dose, luteinizing hormone releasing hormone agonist initiation, or surgical castration Prior adjuvant hormonal therapy completed more than 12 months before randomization, provided the total duration of therapy did not exceed 24 months. For depot formulations, treatment is considered to have started with the first dose and completed when the next scheduled dose would have been due, for example 12 weeks after the last dose of depot goserelin 10.8 milligram h) Current or prior participation in another clinical trial involving investigational agents for prostate cancer or other conditions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Radiographic progression-free survival (rPFS)Timepoint: From the date of randomization to radiographic progression or death, whichever occurs first | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Overall survival(Death from any cause) 2.Time to development of castration-resistant prostate cancer (CRPC) 3.Prostate-specific antigen (PSA) progression-free survival 4.Time to symptomatic skeletal events 5.Adverse events and treatment-related toxicity (CTCAE v5.0) 6.Health-related quality of life (EORTC QLQ-C30, PR-25, EQ-5D-5L) 7.Time to first major adverse cardiovascular event 8.Treatment related cardiometabolic events 9.Health economic outcomes, including incremental cost-effectiveness ratio Timepoint: 1. From randomization until death or last follow-up (for overall survival) 2. From randomization until development of castration-resistant prostate cancer 3. From randomization until PSA progression, clinical progression, or death, whichever occurs first 4. From randomization until first symptomatic skeletal event 5.From start of treatment until 30 days after last dose of study treatment (for safety assessment) 6. At baseline, during treatment, every 12 weeks until clinical progression, at progression, and during follow-up (for quality of life assessments) 7. From randomization until first major adverse cardiovascular event 8. During treatment and follow-up period with regular assessments (every 3 weeks during initial treatment phase and every 12 weeks thereafter) 9. Throughout the study duration including baseline, treatment period, and follow-up (for health economic evaluation) | — |
Countries
India
Contacts
Public ContactAparna Sharma
National Cancer Institute, Aiims, Jhajjar
Outcome results
None listed