PROstate Cancer TReatment Optimization Via Analysis of Circulating Tumour DNA (PROTRACT)

  • STATUS
    Recruiting
  • End date
    Dec 1, 2024
  • participants needed
    100
  • sponsor
    British Columbia Cancer Agency
Updated on 4 October 2022
Investigator
Daniel Khalaf, MD
Primary Contact
BC Cancer - Surrey Centre (3.7 mi away) Contact
+3 other location
ct scan
platelet count
direct bilirubin
gilbert's syndrome
testosterone
metastasis
progressive disease
neutrophil count
docetaxel
bone scan
abiraterone
orchiectomy
enzalutamide
gonadotropin releasing hormone
conjugated bilirubin
adenocarcinoma
prostate adenocarcinoma

Summary

The purpose of this study is to assess the strategy in treatment selection using ctDNA fraction as a predictive biomarker to direct treatment decision (ctDNA fraction <2% receives enzalutamide, and ctDNA fraction ≥2% receives docetaxel) versus clinician's choice of enzalutamide or docetaxel, in subjects with metastatic castration-resistant prostate cancer post abiraterone setting.

Description

This is a prospective, open-label, phase II trial with 1:1 randomization to either Arm A biomarker directed therapy (patients with ctDNA fraction <2% receive enzalutamide, and ctDNA fraction ≥2% receive docetaxel), versus Arm B clinician's choice of enzalutamide or docetaxel, in subjects with metastatic castration-resistant prostate cancer post abiraterone. At time of progression, patient will cross-over to the other therapy (e.g., enzalutamide to docetaxel, and docetaxel to enzalutamide).

Details
Condition Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Treatment docetaxel, Enzalutamide
Clinical Study IdentifierNCT04015622
SponsorBritish Columbia Cancer Agency
Last Modified on4 October 2022

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