Study on Olaparib Plus Abiraterone as First-line Therapy in Men With Metastatic Castration-resistant Prostate Cancer

Official Title

A Randomised, Double-blind, Placebo-controlled, Multicentre Phase III Study of Olaparib Plus Abiraterone Relative to Placebo Plus Abiraterone as First-line Therapy in Men With Metastatic Castration-resistant Prostate Cancer (PROpel Study)

Summary:

The purpose of this study is to evaluate the efficacy and safety (including evaluating side effects) of combination of olaparib and abiraterone versus placebo and abiraterone in patients with metastatic castration-resistant prostate cancer (mCRPC) who have received no prior cytotoxic chemotherapy or new hormonal agents (NHAs) at metastatic castration-resistant prostate cancer (mCRPC) stage.

Trial Description

Primary Outcome:

  • Radiological progression free survival (rPFS)
Secondary Outcome:
  • Time to first subsequent anticancer therapy or death (TFST)
  • Time to pain progression (TTPP)
  • Overall survival (OS)
  • Time to opiate use
  • Time to a Symptomatic Skeletal-Related Event (SSRE)
  • Circulating Tumour Cells (CTC) conversion
  • Time to second progression or death (PFS2)
  • Brief Pain Inventory-Short Form (BPI-SF)
  • Functional Assessment of Cancer Therapy- Prostate Cancer (FACT-P)
  • Homologous Recombination Repair (HRR) gene status
  • Maximum plasma concentration at steady state [Cmax,ss]
  • Time to maximum plasma concentration at steady state (Cmax,ss) [tmax,ss]
  • Minimum plasma concentration at steady state [Cmin,ss]
  • Partial area under the concentration-time curve in 0-8 h [AUC0-8])
  • Maximum plasma concentration at steady state [Cmax,ss]
  • Time to maximum plasma concentration at steady state (Cmax,ss) [tmax,ss]
  • Minimum plasma concentration at steady state [Cmin,ss]
  • Partial area under the concentration-time curve [AUC0-8])
  • Number of adverse events
  • Vital signs-blood pressure
  • Vital signs-pulse rate
  • Vital signs-body temperature
  • ECG
  • Change in Albumin (g/L)
  • Change in Alkaline phosphatase (U/L)
  • Change in Aspartate aminotransferase (U/L)
  • Change in Amylase (U/L)
  • Change in Alanine aminotransferase (U/L)
  • Change in Total bilirubin (μmol/L)
  • Change in Direct bilirubin
  • Change in Calcium (mmol/L)
  • Change in Chloride (mmol/L)
  • Change in Creatinine (μmol/L)
  • Change in Gamma glutamyltransferase (U/L)
  • Change in Fasting gucose (mmol/L)
  • Change in Lactate dehydrogenase (U/L)
  • Change in Magnesium (mmol/L)
  • Change in Potassium (mmol/L)
  • Change in Phosphorus ((mmol/L)
  • Change in Sodium (mmol/L)
  • Change in Carbon dioxide (mEq/L )
  • Change in Total protein (g/L)
  • Change in Urea or blood urea nitrogen, depending on the local practice (mmol/L)
  • Change in absolute neutrophil count (/L)
  • Change in absolute lymphocyte count (/L)
  • Change in haemoglobin (g/L)
  • Change in platelet count with differential (/L)
  • Change in total white blood cell count with differential(/L)
  • Change in red blood cell count (/l)
  • Change in Haematocrit (%)
  • Change in Mean Cell Volume (fL)
  • Urinalysis:change in blood
  • Urinalysis: Change in protein
  • Urinalysis: change in glucose
This is a phase III study evaluating the efficacy, safety, and tolerability of olaparib versus placebo when given in addition to abiraterone to genetically unselected patients with metastatic castration-resistant prostate cancer (mCRPC) who have not received prior chemotherapy or new hormonal agents (NHAs) for metastatic castration-resistant prostate cancer (mCRPC) (first-line setting). Approximately 720 patients will be randomised in a 1:1 ratio to treatment (olaparib in combination with abiraterone or placebo in combination with abiraterone) into the trial.

View this trial on ClinicalTrials.gov

Interested in this trial?

Print this page and take it to your doctor to discuss your eligibilty and treatment options. Only your doctor can refer you to a clinical trial.

Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society