ARMOR3-SV
Research type
Research Study
Full title
ARMOR3-SV: A Phase 3, Randomized, Open-Label, Multi-Center, Controlled Study of Galeterone Compared to Enzalutamide in Men Expressing Androgen Receptor Splice Variant-7 mRNA (AR-V7) with Metastatic (M1) Castrate Resistant Prostate Cancer (CRPC)
IRAS ID
173148
Contact name
Johann de Bono
Contact email
Sponsor organisation
Tokai Pharmaceuticals Inc
Eudract number
2014-005079-10
Duration of Study in the UK
1 years, 8 months, 1 days
Research summary
The purpose of this study is to determine how safe and effective galeterone is in treating patients with Metastatic (M1) Castrate Resistant Prostate Cancer (mCRPC), compared to enzalutamide, a drug which is already approved for the treatment of mCRPC in some countries e.g. US. The study is in men with a particular type of prostate cancer referred to as ‘androgen receptor variant 7’ (AR-V7), who have not yet received chemotherapy, abiraterone or enzalutamide for mCRPC. Patients will have an initial blood test to see if they have this form of the disease.
The primary purpose of this research study will be to compare the time it takes for tumors to grow based on CT or MRI scans in patients who receive galeterone compared to a standard treatment of enzalutamide. This study will also compare other effects between the two treatments such as quality of life, degree of pain, the time it takes before starting another cancer therapy, decreases in prostate specific antigen (PSA) and evaluation of tumor shrinkage. The study will also determine how long patients live following each treatment.
Eligible patients will be randomly assigned 1:1 to receive either galeterone (2550mg total dose in tablet form) or enzalutamide (160mg total dose in capsule form). The study is open-label and therefore both patients and study doctors will know what treatment patients are assigned to receive.
Patients will attend a number of clinic visits in which procedures will be conducted in order to test the safety and efficacy of galaterone. Study procedures include demographics, CTC (AR-V7 analysis), medical/oncology history, vital signs, 12-lead ECG, blood tests, urinalysis, CT/MRI scans, completion of a compliance diary and requesting patients to complete a series of questionnaires about how they are feeling.
REC name
London - Chelsea Research Ethics Committee
REC reference
15/LO/0564
Date of REC Opinion
5 Jun 2015
REC opinion
Further Information Favourable Opinion