The ACE Study
Research type
Research Study
Full title
A Phase IV study to evaluate cognitive function in metastatic castrate resistant prostate cancer (mCRPC) patients treated with Abiraterone Acetate + Prednisolone (AAP) or Enzalutamide (ENZ).
IRAS ID
230002
Contact name
Amit Bahl
Contact email
Sponsor organisation
University Hospitals Bristol NHS Foundation Trust
Duration of Study in the UK
4 years, 0 months, 0 days
Research summary
This is a prospective observational study to assess the impact of hormone tablets Abiraterone Acetate + Prednisolone (AAP) or Enzalutamide (ENZ) on cognitive function, patient reported cognitive function, fatigue, mood in metastatic castrate resistant prostate cancer patients. Patients will be approached to take part in the study at the time of initiation of either AAP or ENZ treatment. The decision to commence patients on AAP or ENZ will have been taken independently prior to enrolling the patient into the study. \n\nAll treatment will be as per local standard practice, however the following patient reported outcomes are performed at each time point: Familiarisation, Baseline, 3, 4, 6, 12 months.\n\n1)\tCANTAB Cognitive assessment \n2) Functional Assessment of Cancer Therapy)-Cog (FACT-Cog)\n3)\tFunctional Assessment of Cancer Therapy – Fatigue (FACT-F)\t\n4)\tDepression scores (PHQ-9)\n\nThe main purpose of the study is to investigate whether there are significant differences in cognitive function, between both treatments from Baseline to the 6 month time point.\n\nAndrogen deprivation therapy forms the mainstay of treatment in men with metastatic prostate cancer. However, up to 50% become castrate resistant within 12 months, necessitating a switch in treatment to systemic chemotherapy. The use of Docetaxel in this setting has proved to be efficacious, but not without associated toxicity. Although AAP and ENZ have been shown to extend patient survival and improve health-related quality of life, long term trial data on the impact of cognitive function, fatigue and depression levels, is lacking.\n\nAs per the current NICE guidance, patients can be switched from AAP to ENZ and vice versa only if the patient experiences significant toxicity within 3 months without disease progression. In clinical practice, it feels that the impact on the cognition is more evident after 3 months of treatment initiation, precluding the switch to another agent.
REC name
South West - Central Bristol Research Ethics Committee
REC reference
18/SW/0167
Date of REC Opinion
18 Sep 2018
REC opinion
Further Information Favourable Opinion