Randomised phase II study of enzalutamide (MDV3100) in combination with AZD5363 in patients with metastatic castration-resistant prostate cancer.
Disease site: Prostate cancer, urological cancers
Treatment modality: Systemic therapy
Status: Open to recruitment
RE-AKT is a multicentre, prospective, randomised, phase II trial in men with metastatic castration-resistant prostate cancer. RE-AKT has three parts:
- First, a phase I safety run-in to identify the safety and tolerability of enzalutamide and AZD5363. This cohort is now closed to recruitment; 16 participants were treated at The Royal Marsden NHS Foundation Trust over nine months.
- A randomised phase II part will determine the efficacy of AZD5363 plus enzalutamide versus placebo plus enzalutamide. This part is now open; 100 participants will be recruited to this phase from 15 UK centres over 18 months.
- At the same time as the randomised phase II part, a single stage phase II expansion cohort will run to determine the efficacy of AZD5363 plus enzalutamide in patients who previously progressed on enzalutamide alone. A total of 18 participants will be recruited from approximately five UK hospitals.
Participants will receive treatment until disease progression. After discontinuing trial treatment, all patients will be followed up for an end of treatment safety assessment and phase II participants will be followed up every three months for the first year, and then every six months for life.
Chief Investigator: Professor Johann de Bono, The Institute of Cancer Research
ICR-CTSU Scientific Lead: Dr Emma Hall
Trial management contact: [email protected]
Sponsor: The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust
Funding: AstraZeneca and endorsed by Cancer Research UK (CRUKE/12/050)
A plain English summary is available from Cancer Research UK.
View RE-AKT on the UK Clinical Trials Gateway.
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