SINGLE ARM OPEN LABLE PHASE II PILOT STUDY OF CARBOPLATIN
Automatisch geschlossen · 2014 bis 2017
Omlin Aurelius, Gillessen Sommer Silke, Haile Sarah, Jochum Wolfram
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
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.