None listed
Conditions
Brief summary
This study aims to aims to test whether treatment with simvastatin during therapy for metastatic castration-resistant prostate cancer can reverse a poor prognostic plasma lipid signature. Who is it for? You may be eligible to join this study if you are a man aged 18 years or above diagnosed with metastatic castration-resistant prostate cancer and starting chemotherapy (docetaxel or cabazitaxel) or novel anti-androgen treatment (abiraterone or enzalutamide) shortly. Study details All study participants will be treated with simvastatin 40mg daily (oral tablet) for 12 weeks, at the same time as starting treatment (docetaxel, cabazitaxel, abiraterone or enzalutamide). All participants will be followed up for 12 weeks to monitor safety and to assess the lipid profile using plasma samples. It is hoped that this study will help answer the question of whether a 12 week course of a lipid-lowering drug called simvastatin (commonly used to treat high cholesterol, heart disease and diabetes) will lower the specific circulating lipids in blood that are associated with a worse prognosis in metastatic castration-resistant prostate cancer.
Interventions
The aim of the study is to assess whether treatment with simvastatin during treatment for metastatic castration-resistant prostate cancer can reverse a poor prognostic plasma lipid signature.
Participants will be treated with simvastatin 40mg daily (oral tablet) for 12 weeks, at the same time as starting chemotherapy (docetaxel or cabazitaxel) or novel anti-androgen treatment (abiraterone or enzalutamide).
Adherence to simvastatin will be assessed by investigators through regular clinic visits d
The aim of the study is to assess whether treatment with simvastatin during treatment for metastatic castration-resistant prostate cancer can reverse a poor prognostic plasma lipid signature. Participants will be treated with simvastatin 40mg daily (oral tablet) for 12 weeks, at the same time as starting chemotherapy (docetaxel or cabazitaxel) or novel anti-androgen treatment (abiraterone or enzalutamide). Adherence to simvastatin will be assessed by investigators through regular clinic visits during treatment.
Sponsors
Chris O'Brien Lifehouse
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Males with castration-resistant metastatic prostate cancer (as per PCWG3) AND commencing docetaxel, cabazitaxel, abiraterone or enzalutamide for disease progression 2. Age 18 yrs or over 3. WHO ECOG performance status 0-2 4. Histological confirmation of prostate cancer 5. Adequate hepatic function with serum total bilirubin < 1.5 x upper limit of normal range and ALT and AST < 2.5x upper limit of normal range (or < 5.0 times ULN with documented liver metastases), serum albumin > 25 g/L, and ALP < 5x upper limit of normal range 6. Adequate renal function (with calculated creatinine clearance >50 ml/min based on the Cockcroft-Gault method, 24 hour urine or GFR scan) and serum creatinine < 1.5 x upper limit of normal range; 7. Willing and able to comply with all study requirements, including treatment and biospecimen collection 8. Signed written informed consent
Exclusion criteria
1. Patients already receiving a lipid lowering agent(s), or have received one in the last 4 weeks 2. Known hypersensitivity to statins or its excipients 3. Prior myopathy with a lipid lowering agent 4. Active hepatic disease, including chronic active hepatitis B or hepatitis C. Testing for these is not mandatory unless clinically indicated. 5. Serious medical or psychiatric conditions that might limit the ability of the patient to comply with the protocol.
Outcome results
None listed