Health Condition 1: C61- Malignant neoplasm of prostate
Conditions
Interventions
Intervention1: Group 1 : abiraterone acetate plus prednisone group with ADT: Patients in the abiraterone acetate plus prednisone group were to receive abiraterone acetate 1000 mg (four 250 mg or four
Sponsors
AIIMS Bhubaneswar
Eligibility
Inclusion criteria
Inclusion criteria: 1.Men aged 18 years and older with newly diagnosed and histologically or cytologically confirmed adeno- carcinoma of the prostate without neuroendocrine differentiation or small cell histology, with distant metastatic disease documented by positive bone scan or metastatic lesions on CT or MRI as per the Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1 criteria, and with Eastern Cooperative Oncology Group (ECOG) performance status score of 0â??2 were included. Additionally, patients were required to have at least two of three high-risk prognostic factors (Gleason score >=8, three or more lesions on bone scan, and measurable visceral metastases, excluding lymph node metastasis). Patients were also required to have adequate haematological, hepatic, and renal function . 2.Written informed consent.
Exclusion criteria
Exclusion criteria: 1.Patients with small-cell carcinoma of the prostate, brain metastasis, uncontrolled hypertension, or with clinically significant cardiac, adrenal, or liver disease, or malignancy other than prostate or non-melanoma skin cancer within the previous 5 years were excluded. 2. Patients who had received previous chemo- therapy, radiotherapy, or surgery for metastatic prostate were excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Overall Survival-OS (time from randomization to death from any cause) and 2.Radiographic progression-free survival â?? rPFS (time from randomization to occurrence of radiographic progression, based on the modified Prostate Cancer Working Group 2 criteria or RECIST, version 1.1) Timepoint: Two interim analyses for overall survival were planned after 50% (about 102) of expected deaths (first interim analysis) and 65% (about 132) of the total 210 patients. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Time to next symptomatic skeletal event 2.Time to subsequent prostate cancer therapy 3.Time to prostate-specific antigen progression 4. Secondary progression-free survivalTimepoint: As the patient becomes symptomatic or disease progresses | — |
Countries
India
Contacts
Public ContactSwarnendu Mandal
AIIMS Bhubaneswar
Outcome results
None listed