Abiraterone with Different Steroid Regimens in Prostate Cancer
Research type
Research Study
Full title
A Randomized Phase 2 Study Evaluating Abiraterone Acetate With Different Steroid Regimens for Preventing Symptoms Associated With Mineralocorticoid Excess in Asymptomatic, Chemotherapy-Naïve and Metastatic Castration-Resistant Prostate Cancer (mCRPC) Patients
IRAS ID
123473
Contact name
Frank De Beukelaar
Contact email
Sponsor organisation
Janssen-Cilag International N.V.
Eudract number
2012-004331-23
Clinicaltrials.gov Identifier
NCRN541, National Institute for Health Research Cancer Research Network (NCRN)
Duration of Study in the UK
4 years, 10 months, 8 days
Research summary
The aim of this trial is to compare and evaluate four alternative treatment strategies for preventing certain symptoms arising from prostate cancer treatment.
Mineralocorticoid excess can occur during treatment with abiraterone. Mineralocorticoids are a group of steroid hormones that influence salt and water balances in the body. Symptoms of mineralocorticoid excess include hypertension[increased blood pressure], hypokalemia [low blood potassium], and fluid retention. Administration of low dose corticosteroids improves symptoms of fatigue and the tolerability of abiraterone acetate, including symptoms of mineralocorticosteroid excess.
Abiraterone, in combination with prednisone or prednisolone, is licensed for metastatic castration-resistant prostate cancer (mCRPC) in patients whose disease has progressed during or after treatment with a docetaxel-containing chemotherapy regimen. It is generally well-tolerated. However, it has been documented that following prolonged therapy with corticosteroids (eg prednisolone) patients may develop symptoms of Cushing’s syndrome, which include thin skin, easy bruising, adiposity (excessive accumulation of fat in a site or organ), proximal myopathy (muscle wasting).
144 patients with mCRPC who currently have no symptoms and have not previously received chemotherapy will be entered into the trial. They will all receive abiraterone. In addition they will be randomized to receive one out of four possible steroid regimens: prednisone 5 mg twice daily (arm 1), prednisone 5 mg once daily (arm 2), prednisone 2.5 mg twice daily (arm 3) or dexamethasone 0.5 mg once daily (arm 4).
The main study will consist of a screening phase of 3 weeks followed by an open-label treatment period of a maximum of 156 weeks. Participants will receive study treatment until their condition progresses or they meet one of the other criteria for discontinuation. Trial assessments include periodic blood tests, DXA scans and questionnaires.The primary research outcome will be whether or not participants exhibit symptoms of steroid-related toxicities after 24 weeks of treatment.
This is an international trial. In the UK, participants will be recruited from specialist cancer treatment centres.
REC name
London - City & East Research Ethics Committee
REC reference
13/LO/0582
Date of REC Opinion
26 Jun 2013
REC opinion
Further Information Favourable Opinion