TRITON3: A Multicenter, Randomised,Phase 3 Study of Rucaparib in mCRPC

• Research type

  Research Study

• Full title

  TRITON3: A Multicenter, Randomized, Open-label Phase 3 Study of Rucaparib versus Physician’s Choice of Therapy for Patients with Metastatic Castration-resistant Prostate Cancer Associated with Homologous Recombination Deficiency

• IRAS ID

  222298

• Contact name

  Elias Pintus

• Contact email

  EliasPintus@nhs.net

• Sponsor organisation

  Clovis Oncology, Inc.

• Eudract number

  2016-003163-20

• Clinicaltrials.gov Identifier

  NCT02975934

• Duration of Study in the UK

  4 years, 7 months, 30 days

• Research summary

  The purpose of this study is to find out if a drug called rucaparib is safe and effective in treating patients with prostate cancer who have a mutation in one of their DNA repair gene, compared to one of the standard approve treatments (abiraterone acetate, enzalutamide, or docetaxel).
  As part of this study,tumor tissue and blood samples may be collected to look for biomarkers (substances such as genetic material (DNA) and proteins ) in order to develop a diagnostic test that might help show which patients with prostate cancer are most likely to benefit from treatment with rucaparib.

  Cells continuously need to repair their DNA to carry on living. Cells with a DNA repair gene mutation, including cancer cells, can still repair their DNA via alternatives routes but if these routes are also blocked, the cell dies. Rucaparib
  belongs to a class of drugs which may block this alternative route of repair,thereby causing the cancer cell to die.
  The study will look at how patients respond to treatment through review of tumour scans, prostate-specific antigen (PSA) blood levels and any side effects that occur. Researchers will also look at the effect of treatment on patients’ quality of life, degree of pain and the time it takes before another cancer treatment is needed.
  Study patients will come to clinic for study visits every 2 weeks for the first 2 months and every 4 weeks thereafter, and scans will occur every 8 weeks for the first 6 months and every 12 weeks thereafter. Patients randomized to Rucaparib or Abiraterone Acetate or Enzalutamide will receive it orally on a daily basis. Patients randomized to Docetaxel will receive an infusion every 3 weeks.

• REC name

  East Midlands - Nottingham 2 Research Ethics Committee

• REC reference

  17/EM/0120

• Date of REC Opinion

  28 Apr 2017

• REC opinion

  Further Information Favourable Opinion