Evolocumab in Metastatic Castration-Resistant Prostate Cancer

Phase 2

Recruiting

• Conditions: Metastatic Castrate Resistant Prostate Cancer; Cancer - Prostate

• Registration Number: ACTRN12622001003763
• Lead Sponsor: ational Health and Medical Research Council

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-07-18
• Last Update Posted: 16 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Male
• Target Recruitment: 30

Inclusion Criteria

1.Males with mCRPC (as per prostate cancer working group (PCWG3)) AND commencing docetaxel, cabazitaxel, abiraterone or enzalutamide for disease progression
2.Age > 18 yrs
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 (ULN) 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.Demonstrated positivity for high-risk circulating plasma lipid profile on Liquid chromatography–mass spectrometry (LCMS)
8.Willing and able to comply with all study requirements, including treatment and biospecimen collection
9.Signed written informed consent

Exclusion Criteria

1.Known hypersensitivity to evolocumab or its excipients
2.Prior myopathy with a lipid lowering agent
3.Active hepatic disease, including chronic active hepatitis B or hepatitis C. Testing for these is not mandatory unless clinically indicated.
4.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
Change in circulating lipid profile assessed by measuring levels of ceramides in a blood sample with the concomitant use of evolocumab in men commencing chemotherapy (docetaxel or cabazitaxel) or ARSI therapy (abiraterone or enzalutamide) for metastatic castrate resistant prostate cancer (mCRPC). <br><br>[ Baseline and at 12 weeks post-treatment commencement]

Secondary Outcome Measures

Name	Time	Method
Change in PSA levels assessed using a blood sample<br>[ Baseline and at 12 weeks post-treatment commencement];Adverse events (worst grade according to National cancer institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03.<br><br>The proportion of patients experiencing treatment-related toxicities, as defined by the Common Toxicity Criteria v4.0 of the National Cancer Institute (NCI CTC v4.03) and reporting of Serious Adverse Events (SAEs). The NCI CTCAE v4.03 will be used to classify and grade the intensity of adverse events after each dose of evolocumab. <br>[ This outcome will be assessed at 4, 8, and 12 weeks following evolocumab treatment commencement.]