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Clinical Trials/CTRI/2018/06/014592
CTRI/2018/06/014592
Other
Phase 4

An open label, observational, multicentric, prospective, single arm, drug utilization surveillance study to evaluate safety and efficacy of Abiraterone acetate in chemonaive patients with metastatic prostate cancer

Glenmark Pharmaceuticals Ltd0 sites0 target enrollmentTBD
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ConditionsHealth Condition 1: C61- Malignant neoplasm of prostateHealth Condition 2: null- Metastatic Prostate Cancer

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Health Condition 1: C61- Malignant neoplasm of prostateHealth Condition 2: null- Metastatic Prostate Cancer
Sponsor
Glenmark Pharmaceuticals Ltd
Status
Other
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional

Investigators

Eligibility 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

  • •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

Outcomes

Primary Outcomes

Not specified

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