Abiraterone acetate [ABI5]

For the treatment of high-risk, hormone sensitive, non-metastatic prostate cancer where the following criteria have been met:

1. This application is being made by and that abiraterone acetate will be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anti-cancer therapy.
2. The patient has newly diagnosed high-risk, hormone sensitive prostate cancer or relapsing prostate cancer with high-risk features planned for standard of care treatment with radiotherapy (unless contraindicated). NOTE – patients who have already commenced treatment with abiraterone in this indication, funded locally, or using self-funding can transfer to NHSE commissioned drug as long as all other criteria on this form are met.
3. The patient meets the following eligibility criteria: •WHO performance status 0-2 AND •Non-metasta c (M0) AND EITHER •Pelvic node posi ve (N1) OR •In NEWLY DIAGNOSED high-risk prostate cancer •Node nega ve (N0) with at least two of: otumour stage T3 or T4 oGleason score 8-10 oProstate specific an gen (PSA) ≥ 40 nanograms/ml •In RELAPSING prostate cancer with high-risk features •Node nega ve (N0) with one of either oA PSA of equal to or greater than 4 nanograms/ml with a doubling me of <6 months oA PSA of greater than or equal to 20 nanograms/ml
4. The patient is aged 18 years or over.
5. The patient does not meet any of the following exclusion criteria: • patients with contraindications to abiraterone acetate, as outlined in the summary of product characteristics (SmPC) • patients with confirmed clinically significant cardiovascular disease
6. The patient has been discussed at an appropriate multidisciplinary team (MDT) meeting prior to starting treatment (for patients who are transferring from alternative funding streams, as in criteria 2, a further MDT discussion is NOT required).
7. The patient has been started on androgen deprivation therapy (ADT) prior to starting abiraterone acetate, and that ADT has been given for a MAXIMUM of three months before abiraterone is commenced.
8. The patient will receive the recommended dose of abiraterone acetate as suggested in the NHS England Clinical Commissioning Policy.
9. The stopping / exit criteria have been explained and agreed with the patient able to receive abiraterone until whichever of the following events occur • a serious adverse event or intolerance related to treatment OR • evidence of disease progression OR • withdrawal of patient consent OR • a treatment duration of TWO years is reached, at which point abiraterone must be stopped
10. Trust policy regarding off-label treatments has been followed as abiraterone is not licensed for this indication.
11. Abiraterone acetate will be otherwise used as set out in its Summary of Product Characteristics (SPC).

NHS funded From: 16 January 2026

Additional information

Form version: -

CDF Managed Access: NA

NICE Technology Appraisal: NHS Policy 2312 (NA)

Current Form Version

Note

The data on this page was produced using version 1.385 of the CDF list, downloaded from NHS England’s website on 27 January 2026 at 22:25.

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