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About this trial

The purpose of this study is to focus on the potential role of abiraterone acetate in treatment-naive patients newly diagnosed with high-risk localised prostate cancer requiring combined hormonal therapy and radiotherapy.

The combination of hormonal therapy and radiotherapy represents one of the standard treatment options for patients diagnosed with localised prostate carcinoma (cancer that is confined to the prostate gland).

Abiraterone acetate is a new drug that blocks the production of androgens (male hormones which influence the growth and development of the male reproductive system, e.g. testosterone) by the prostate cancer itself, as well as in the testes and adrenal glands. Abiraterone acetate has been shown to improve survival in patients who have had progressive disease after treatment with chemotherapy.

Abiraterone acetate can also delay disease progression in men who have not had chemotherapy. Several on-going research studies are currently assessing the role of abiraterone acetate in various stages of prostate carcinoma. Abiraterone acetate must be taken with prednisolone to avoid a serious complication.

Every patient on this study will receive abiraterone acetate in combination with prednisolone and a GnRH agonist (hormone injection). Treatment with GnRh agonist (hormone injection) is standard treatment. It is thought that this combination therapy prior to radiotherapy may improve outcomes.

The effect of the combination treatment on prostate volume, prostate-specific antigen (PSA levels), and clinical response will be assessed at the end of treatment.

Patient Profile

Patients newly diagnosed with high-risk localised prostate cancer requiring combined hormonal therapy and radiotherapy

Where’s this trial being run?

Cork University Hospital, St Luke’s Radiation Oncology Network @ St Luke’s Hospital, and University Hospital Galway

Can I join this study / trial?

The first thing you do is to talk to your doctor and/or the cancer trials research team in your hospital. The contact details for the cancer trials research units in Ireland is here.

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Questions?

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Summary Data

Name: Neo-adjuvant abiraterone prostate study
Number: 13-23
Full Title:

Phase II Non-randomised single arm study evaluating Neo-adjuvant (pre-radical radiotherapy) Abiraterone acetate (plus prednisolone) and Gonadotropin-releasing hormone (GnRh) agonist in Localised Prostate Cancer

Principal Investigator: Dr Pierre Thirion (St. Luke's Hospital)
Type: In-House
Sponsor:

Cancer Trials Ireland

Recruitment Started: Global: Not Applicable
Ireland: May 2015
Global Recruitment Target: Not Applicable
Ireland Recruitment Target: 36