TOPARP

• Research type

  Research Study

• Full title

  TOPARP: Phase II Trial of Olaparib in Patients with Advanced Castration Resistant Prostate Cancer.

• IRAS ID

  76882

• Contact name

  Johann De Bono

• Sponsor organisation

  The Institute of Cancer Research

• Eudract number

  2011-000601-49

• ISRCTN Number

  n/a

• Research summary

  Prostate cancer is the second commonest cause of male cancer death in the UK with a third of patients developing advanced disease. This initially responds to treatment called androgen deprivation, but invariably progresses to a terminal phase, called castration-resistant. Docetaxel is the mainstay of treatment for patients with metastatic castrate-resistant prostate cancer (mCRPC) but only 40-45% of patients have a survival benefit from this treatment. Thus, effective therapeutic options that offer sustained responses and clinical benefit for mCRPC patients remain an important area of unmet medical need. Prostate cancer is a clinically and molecularly heterogeneous disease. Improved understanding of the biological and clinical significance of the molecular sub-classification of this disease could positively impact treatment outcomes by allowing doctors to target the most appropriate therapy for patients. We hypothesise that a proportion of mCRPC have defects in a form of DNA repair. The drug olaparib has shown activity in other cancer types that have this DNA repair deficit and we are testing whether mCRPC patients also will benefit from olaparib treatment. We also hope that predictive biomarkers can be identified to define this patient population. The aims and objectives of this trial are therefore:1) To evaluate the antitumour activity of olaparib in mCRPC. 2) To identify predictive biomarkers of HR repair deficiency for mCRPC. To do this, we have developed a novel trial designed to test the benefit of the drug while looking for molecular predictors of clinical response.

• REC name

  London - Surrey Borders Research Ethics Committee

• REC reference

  11/LO/2019

• Date of REC Opinion

  29 Dec 2011

• REC opinion

  Favourable Opinion