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RE-AKT: A trial looking at AZD5363 and enzalutamide for advanced prostate cancer

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What is the study about?

RE-AKT investigates whether a new combination of drugs can help treat people with advanced prostate cancer.

Naturally occurring hormones encourage the growth of prostate cancer. People with prostate cancer receive treatment to block the action of these hormones, but this treatment can stop working. RE-AKT investigates whether a different type of hormone blocker called enzalutamide can help slow down cancer growth in combination with a new drug called capivasertib (AZD5363). Capivasertib blocks a molecule called AKT which is produced by cancer cells and encourages cancer to grow.

RE-AKT has several stages, or phases:

  • Phase I established the best dose of capivasertib for participants to receive in combination with enzalutamide. 
  • Phase II investigated how well the combination of enzalutamide and capivasertib slowed participants’ cancer growth.

Who is included in the study?

RE-AKT includes people with advanced prostate cancer whose treatment is no longer working. 187 people joined the trial from 15 NHS hospitals in the UK.

What are the study treatments?

In phase I, all participants received the combination treatment of enzalutamide and capivasertib. The dose of capivasertib was increased until the highest dose that could be safely given in combination with enzalutamide was found. 

Phase II had two parts, the randomised part and the expansion part.

Randomised part 

All participants received either:

  • Enzalutamide plus a placebo (a tablet designed to look like the medicine being tested but has no medical effect) 
  • Enzalutamide plus capivasertib

No one in either group, or their doctors, were told whether they were having the placebo or capivasertib.

Expansion part

Everyone included in the expansion part of RE-AKT had already had enzalutamide treatment but their cancer had grown whilst receiving enzalutamide on its own. Everyone in this part of the trial received enzalutamide plus capivasertib.

What are the study results?

Results of RE-AKT Phase I - lay summary

RE-AKT Phase I primary publication

Further information for participants

Patient Information Sheet Phase 1

Patient Information Sheet Phase 2 (Randomised Part)

Patient Information Sheet Phase 2 (Expansion Part)

A detailed summary is available on Cancer Research UK’s website.

Further information for healthcare professionals

Protocol

Contact details and regulatory information

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

ICR-CTSU scientific lead: Professor 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

Trial identifiers

EUDRACT number: 2013-004091-34

REC reference: 14/LO/0259

CPMS ID: 16580

ISRCTN17168679

Publications and presentations

There have been no presentations or publications to date.

In this section

RE-AKT trial documents (password required)

Clinical trials

List of ICR-CTSU trials

Division of Clinical Studies

The division carries out or coordinates high-quality trials and translational research at both an early phase – typically to test new targeted drugs – and a later stage.

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