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Kurzbeschreibung/Zielsetzung

Study design:
For the pilot trial a single stage phase II design was chosen. All patients that meet the eligibility criteria will
receive carboplatin AUC3 until progression (radiological or clinical).
A total of 25 patients are required for this study. If 5 or more responses are observed the study results are
considered promising and warrant further testing. (H0: 0.1, H1: 0.3, alpha 0.1, beta 0.9)
With a frequency of PTEN loss of 40-60% a total of 50 patients will need to screened. Only patients with
evidence of PTEN loss can be included in the study.
Key inclusion criteria
 Patients with histological or cytological diagnosis of adenocarcinoma of the prostate.
 Metastatic Castration-Resistant Prostate Cancer (CRPC)
 Progression after at least one taxane-based chemotherapy (or contraindication against taxanes) and at
least one therapy with a newer hormonal agents (Cyp17i or a new generation antiandrogen like
enzalutamide).
 Loss of PTEN in fresh or archival tumour biopsy by IHC
Study sites: The pilot phase of the trial will be performed in 3-4 centres in Switzerland.
Study procedures: Treatment with Carboplatin will be administered weekly (AUC3) until disease progression
(radiological or clinical).
Efficacy assessments: As per Prostate Cancer Working Group Criteria PSA will be measured every 3-4 weeks
and CT and Bone scan will be done every 12 weeks.
Translational research: Archival and fresh tumour tissue as well as plasma will be collected. In collaboration
with R Aebersold (ETH Zurich) translational research questions aiming to identify predictive markers of response
to carboplatin will be performed.