Prostate Cancer Clinical Trial
Official title:
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
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.
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.
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