Open label, non-randomised phase II clinical pilot study
Pilot Study of weekly Carboplatin in Patients with Advanced Metastatic Castration-Resistant Prostate Cancer (CRPC) and DNA repair defects
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Carboplatin will be administered weekly
Cantonal Hospital Chur
Chur, Kanton Graubünden, Switzerland
Luzern Cantonal Hospital
Lucerne, Switzerland
Cantonal Hospital St.Gallen
Sankt Gallen, Switzerland
Response
Soft tissue or PSA Response
Time frame: Time Frame: Up to the end of the treatment phase (ie, approximately 6 months
Rate of PSA declines of ≥30%
PSA
Time frame: Time Frame: At 12 weeks and up to the end of the treatment phase (ie, approximately 6 months)
OS
Overall survival (OS) form start of Carboplatin
Time frame: Time Frame: livelong follow-up
rPFS
Radiological progression-free survival (rPFS) from start of carboplatin
Time frame: Time Frame: Up to the end of the treatment phase (ie, approximately 6 months
PSA
Time to PSA progression
Time frame: on studyTime Frame: Up to the end of the treatment phase (ie, approximately 6 months
Safety as per CTC AEv4.03
Number of patients with adverse events
Time frame: on studyTime Frame: Up to the end of the treatment phase (ie, approximately 6 months
Disease control rate
Disease control rate at 12 and 24 weeks (defined as SD, PR, CR, see response criteria
Time frame: On studyTime Frame: Up to the end of the treatment phase (ie, approximately 6 months
PTEN loss
Evaluation of PTEN loss by FISH (Frequency and correlation with IHC)
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Time frame: Pre-study biopsy sample