SWITCH: Study of the Prednisone to Dexamethasone Change in mCRPC Patients Treated With Abiraterone

NCT02928432 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2017-01-27

No results posted yet for this study

Summary

Abiraterone acetate (AA) has shown a favourable impact in overall survival, administered with prednisone to decrease the adverse event related to CYP171A suppression.

Our hypothesis is that the change of prednisone to dexamethasone in CRPC patients that progress biochemically to AA + prednisone can improve the number and the length of the responses, and also improve tolerance to treatment, decreasing the adverse events associated to a moderate dosage of steroids used chronically.

Conditions

Interventions

DRUG

Steroids switch

Change of prednisone 5mg/12h to dexamethasone 0.5mg/24h

Sponsors & Collaborators

  • Instituto de Investigacion Biomedica de Malaga

    collaborator OTHER
  • Fundación de investigación HM

    collaborator OTHER
  • Institute of Cancer Research, United Kingdom

    collaborator OTHER
  • University of Salamanca

    collaborator OTHER
  • Centro Nacional de Investigaciones Oncologicas CARLOS III

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2016-09-30
Completion
2017-01-31

Countries

  • Spain

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02928432 on ClinicalTrials.gov