Health Condition 1: C61- Malignant neoplasm of prostate Health Condition 2: null- Metastatic Prostate Cancer
Conditions
Interventions
Intervention1: Abirapro (Abiraterone Acetate): 4 X 250 mg for 24 weeks administered once daily orally
Sponsors
Glenmark Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male participants aged greater than or equal to 18 years and less than 75 years 2. Participant (or legally accepted representative) must be able to sign an informed consent form (ICF) indicating that they understand the procedures for data collection and are willing to participate in the study 3. Abiraterone acetate has been chosen as the treatment for metastatic prostate cancer as part of standard care following treatment interruption or resistance with ADT including LHRH analogues and Androgen receptor blockers 4. Symptomatic or Asymptomatic chemonaive mPC patients with greater than or equal to 2 bony lesion 5. Patients with ECOG status 0-1
Exclusion criteria
Exclusion criteria: 1. Participants currently participating in another investigational clinical study. 2. Participants who have any other condition that, in the opinion of the investigator, may affect the participantâ??s health or outcome of the trial 3. Patient with high visceral burden (greater than or equal to 2 visceral organ involved) 4. Patients with acute hepatic impairment i.e. SGPT, SGOT level 5 times more than normal , who needs dose reduction 5. Patients with life expectancy less than 6 months. 6. Patients not able to give consent for participation in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| a. To assess cases of PSA responders i.e. PSA response (greater than or equal to 50 %) according to PCWG2 criteria b. To assess time to PSA Progression ((TTPP; months, defined as duration from baseline to the day of PSA progression according to PCWG2 criteria.) c. To assess time to start of chemotherapyTimepoint: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| a. To assess cases of treatment failure that is cases with PSA progression with two new bony lesion b. To assess safety of Abiraterone acetateTimepoint: 3 months and 6 months | — |
Countries
India
Contacts
Public ContactChandu Devanpally
Glenmark Pharmaceuticals Ltd.
Outcome results
None listed