Statins in Metastatic Castration-Resistant Prostate Cancer

Phase 2

Recruiting

• Conditions: Prostate cancer; Cancer - Prostate

• Registration Number: ACTRN12617000965303
• Lead Sponsor: Chris O'Brien Lifehouse

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-07-05
• Last Update Posted: 7 September 2021

Recruitment & Eligibility

• Status: Recruiting
• Sex: Male
• Target Recruitment: 60

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Presence of a poor prognostic plasma lipid signature: A previous study measured the global lipidomic profile in the plasma of men with metastatic castration-resistant prostate cancer starting docetaxel chemotherapy, using liquid chromatography and electrospray ionisation-tandem mass spectrometry (LC-MS/MS) (1). A three-lipid signature was derived which was prognostic for worse overall survival (1). This study will assess for the presence of this poor prognostic plasma lipid signature at baseline and after 12 weeks of simvastatin.<br>[1. Lin H, Mahon K, Weir J, Mundra P, Spielman C, Briscoe K, et al. A distinct plasma lipid<br>signature associated with poor prognosis in castration-resistant prostate cancer. Int J Cancer. 2017;141(10):2112-20.][Baseline and after 12 weeks of intervention (simvastatin)]

Secondary Outcome Measures

Name	Time	Method
Incidence of adverse events using Common Terminology Criteria for Adverse Events (CTCAE) v4.03<br>- Particularly simvastatin related side effects such as myopathy, rhabdomyolysis and hepatic dysfunction[Monitored every 3 weeks throughout treatment and at a safety assessment 21-30 days following last dose of study treatment]