NCT02928432

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

Phase II Pilot Study of the Prednisone to Dexamethasone Switch in Metastatic Castration Resistant Prostate Cancer (CRPC) Patients With Asymptomatic Biochemical and/or Limited Radiological Progression on Abiraterone and Prednisone

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Centro Nacional de Investigaciones Oncologicas CARLOS III · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This phase II multicentric-study analyse the role of the steroid switch in patients receiving AA. Previous retrospective data (Lorente et al, BJC 2014) has shown that the change of prednisone by dexamethasone in CRPC patients treated with AA post-docetaxel leaded to durable biochemical responses in 40% of cases. Recently, superiority of dexamethasone over prednisone in PSA response has been reported by a phase II trial that included 82 chemotherapy-naive metastatic CRPC patients. In our study patients with biochemical and/or limited radiological progression to AA + prednisone are prospectively enrolled. The principal objective was to evaluate the percentage of PSA responses in clinically stable metastatic CRPC patients after at least 12 weeks of AA + prednisone. Secondary aims will include time to biochemical progression, time to first radiological progression, overall survival and the evaluation of the safety profile. Biochemical response was monitored with PSA determinations every 4 weeks, and defined as a ≥ 30% decline in PSA from baseline, confirmed with a second reading. PSA progression was evaluated according to PCWG2 criteria. Radiological response was re-evaluated every 12-16 weeks using bone and CT-scan according to RECIST v1.1 and PCWG2 criteria. Translational studies: archival tissue will be obtained from all patients, to perform PTEN and TMPRSS-ERG rearrangements evaluation. Plasma will be collected after AA + prednisone progression to study the androgen receptor status in plasma.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	Steroids switch	Change of prednisone 5mg/12h to dexamethasone 0.5mg/24h

Timeline

• Start date: 2013-06-01
• Primary completion: 2016-09-01
• Completion: 2017-01-01
• First posted: 2016-10-10
• Last updated: 2017-01-27

Locations

1 site across 1 country: Spain