To assess activity of abiraterone-re-challenge in patients with advanced prostate cancer and prior response to abiraterone.
To assess activity of abiraterone-re-challenge in patients with advanced prostate cancer and prior response to abiraterone. CRPC patients with prior response to abiraterone (confirmed PSA Response) and progression can be re-challenged with abiraterone. Patients may have received treatment with docetaxel, enzalutamide and radium-223.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
4
Abiraterone acetate 1000 mg once daily and Prednisone 2x5 mg daily (continuously as per prescription label).
Cantonal Hospital Chur
Chur, Kanton Graubünden, Switzerland
University Hospital Basel
Basel, Switzerland
Cantonal Hospital St.Gallen
Sankt Gallen, Switzerland
Response rate
Soft-tissue and PSA Response per PCWG2
Time frame: at week 12
Rate of CTC conversion
Rate of CTC conversion from a baseline count of ≥5/7.5ml to \<5/7.5ml
Time frame: Measured at baseline and at 12 weeks
Rate of PSA decline 30%
Rate of PSA declines of ≥30% at 12 weeks and at any time on study thereafter
Time frame: at week 12
rPFS
From date of start of treatment until the date of first documented progression or date of death from any cause, whichever came first
Time frame: From date of start of treatment up to 6 months
Disease control rate
Disease control rate at 12 and 24 weeks (defined as SD, PR, CR, see response criteria)
Time frame: at 12 and 24 weeks
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