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NCT04015622: PROTRACT
PROstate Cancer TReatment Optimization Via Analysis of Circulating Tumour DNA
Phase 2 trial testing Enzalutamide in Metastatic Castration-Resistant Prostate Cancer (mCRPC) in 100 participants. Participants enrolled and being followed up; not accepting new ones.
1 April 2026
Quick facts
| Lead sponsor | British Columbia Cancer Agency |
|---|---|
| Phase | Phase 2 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 100 |
| Start date | 7 October 2020 |
| Primary completion | 1 April 2026 |
| Estimated completion | 1 December 2026 |
| Sites | 7 locations across Canada |
Drugs / interventions tested
- Enzalutamide (enzalutamide) — full drug profile →
- Docetaxel (Docetaxel) — full drug profile →
Conditions studied
- Metastatic Castration-Resistant Prostate Cancer (mCRPC) — all drugs for Metastatic Castration-Resistant Prostate Cancer (mCRPC) →
Sponsor
British Columbia Cancer Agency
Who can join
18 and older, male only, with Metastatic Castration-Resistant Prostate Cancer (mCRPC). Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Prognostic value of plasma circulating tumor DNA fraction across four common cancer types: a real-world outcomes study.
Reichert ZR, Morgan TM, Li G, Castellanos E, et al · · 2023 · cited 145× · PMID 36208697 · DOI 10.1016/j.annonc.2022.09.163 -
Liquid biopsy into the clinics: Current evidence and future perspectives.
Boukovala M, Westphalen CB, Probst V. · · 2024 · cited 29× · PMID 40027149 · DOI 10.1016/j.jlb.2024.100146 -
Targeted Therapies in Pancreatic Cancer: A New Era of Precision Medicine.
Li B, Zhang Q, Castaneda C, Cook S. · · 2024 · cited 19× · PMID 39457488 · DOI 10.3390/biomedicines12102175 -
Detection of von Hippel-Lindau gene mutation in circulating cell-free DNA for clear cell renal cell carcinoma.
Sumiyoshi T, Yamasaki T, Takeda M, Mizuno K, et al · · 2021 · cited 18× · PMID 34009695 · DOI 10.1111/cas.14972 -
Clinical and pathological features associated with circulating tumor DNA content in real-world patients with metastatic prostate cancer.
Antonarakis ES, Antonarakis ES, Tierno M, Fisher V, et al · · 2022 · cited 17× · PMID 35286728 · DOI 10.1002/pros.24331 -
Finding the optimal treatment sequence in metastatic castration-resistant prostate cancer-a narrative review.
Maurice Dror C, Chi KN, Khalaf DJ. · · 2021 · cited 11× · PMID 34804836 · DOI 10.21037/tau-20-1341 -
Cell-free DNA in the management of prostate cancer: Current status and future prospective.
He W, Xiao Y, Yan S, Zhu Y, et al · · 2023 · cited 9× · PMID 37538150 · DOI 10.1016/j.ajur.2022.11.002 -
Putting comprehensive genomic profiling of ctDNA to work: 10 proposed use cases.
Desai A, Pasquina LW, Nulsen C, Keller-Evans RB, et al · · 2024 · cited 5× · PMID 40027147 · DOI 10.1016/j.jlb.2024.100140
Verify or expand the search:
- PubMed search for NCT04015622
- Europe PMC full search
- ASCO Meeting Library
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Other recruiting trials for Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Currently open trials in the same condition.
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Other British Columbia Cancer Agency trials
Trials by the same sponsor.
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- NCT06835725 — Phase II Randomized Trial of 2 Versus 5 Fraction Prostate Stereotactic Ablative Radiotherapy for Intermediate Risk Prost · Phase 2 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04015622 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by British Columbia Cancer Agency
- Last refreshed: 20 August 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04015622.
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