PROstate Cancer TReatment Optimization Via Analysis of Circulating Tumour DNA
- Conditions
- Metastatic Castration-Resistant Prostate Cancer (mCRPC)
- Interventions
- Registration Number
- NCT04015622
- Lead Sponsor
- British Columbia Cancer Agency
- Brief 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.
- Detailed 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).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Male
- Target Recruitment
- 100
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description A: Biomarker directed Therapy (BT) Docetaxel ctDNA fraction \<2% receives enzalutamide, and ctDNA fraction ≥2% receives docetaxel until disease progression, then cross-over to the other therapy (e.g., enzalutamide to docetaxel, or docetaxel to enzalutamide). B: Clinician's Choice (CC) Enzalutamide Enzalutamide or docetaxel until disease progression, then cross-over to the other therapy (e.g., enzalutamide to docetaxel, or docetaxel to enzalutamide). A: Biomarker directed Therapy (BT) Enzalutamide ctDNA fraction \<2% receives enzalutamide, and ctDNA fraction ≥2% receives docetaxel until disease progression, then cross-over to the other therapy (e.g., enzalutamide to docetaxel, or docetaxel to enzalutamide). B: Clinician's Choice (CC) Docetaxel Enzalutamide or docetaxel until disease progression, then cross-over to the other therapy (e.g., enzalutamide to docetaxel, or docetaxel to enzalutamide).
- Primary Outcome Measures
Name Time Method Progression free survival (PFS) 1 year PFS is defined as the time between the date of starting trial treatment to any of the following: clinical, PSA, radiographic progression, or death from any cause on first-line therapy
- Secondary Outcome Measures
Name Time Method Objective response 1 year To determine the objective response as per RECIST 1.1 in patients treated with biomarker directed therapy vs. clinician's choice.
Correlation of specific ctDNA-based genomic alterations to treatment response 1 year Among mCRPC patients receiving enzalutamide and docetaxel
Second progression free survival (PFS2) 1 year PFS2 is defined as the time elapsed between the date of treatment commencement and the first documented evidence of any disease progression or death from any cause from cross-over second-line therapy.
Clinical benefit rate (CBR) 3 months CBR is defined as PSA or measurable radiological response of any duration or stable disease for ≥ 12 weeks (no symptomatic progression, PSA progression, or objective disease progression).
PSA response rate 1 year PSA response rate is defined as the proportion of patients with a PSA decline (defined as a ≥30%, ≥50% and other declines in PSA from baseline) in mCRPC patients treated with biomarker directed therapy vs. clinician's choice.
Overall survival (OS) 2 years OS is defined as time from treatment commencement to death of any cause of mCRPC patients treated with biomarker directed therapy vs. clinician's choice.
Trial Locations
- Locations (7)
BC Cancer - Centre for the North
🇨🇦Prince George, British Columbia, Canada
BC Cancer - Kelowna (Sindi Ahluwalia Hawkins Centre)
🇨🇦Kelowna, British Columbia, Canada
BC Cancer - Surrey Centre
🇨🇦Surrey, British Columbia, Canada
Sunnybrook Health Sciences Centre
🇨🇦Toronto, British Columbia, Canada
BC Cancer - Vancouver Centre
🇨🇦Vancouver, British Columbia, Canada
BC Cancer - Victoria Centre
🇨🇦Victoria, British Columbia, Canada
London Health Sciences Centre
🇨🇦London, Ontario, Canada