RE-AKT

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: Closed

Trial details

RE-AKT is a multicentre, prospective, randomised, phase II trial in men with metastatic castration-resistant prostate cancer. RE-AKT has three parts:

1. 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.  
2. 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.
3. 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.

Results

We have prepared a lay summary of the RE-AKT Phase I results (PDF).

Further information for potential participants

Patient Information Sheet Phase 2 Expansion

Patient Information Sheet Phase 2

Patient Information Sheet Phase 1

Further information for healthcare professionals

Protocol

Further information 

Chief Investigator: Professor Johann de Bono, The Institute of Cancer Research

ICR-CTSU Scientific Lead: Professor Emma Hall

Trial management contact: [email protected]

ISRCTN: 17168679

Sponsor: The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust

Funding: AstraZeneca and endorsed by Cancer Research UK (CRUKE/12/050)

View RE-AKT on the National Institute for Health Research website: NIHR - Be Part Of Research

A plain English summary of the RE-AKT trial is available from Cancer Research UK.

Publications and presentations

There have been no presentations or publications to date.