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NCT04015622: PROTRACT

PROstate Cancer TReatment Optimization Via Analysis of Circulating Tumour DNA

Active, enrolled Phase 2 Last updated 20 August 2025
What this trial tests

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.

Timeline
7 October 2020
Primary endpoint
1 April 2026
1 December 2026

Quick facts

Lead sponsorBritish Columbia Cancer Agency
PhasePhase 2
StatusActive, enrolled
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingnone
Primary purposetreatment
Enrollment100
Start date7 October 2020
Primary completion1 April 2026
Estimated completion1 December 2026
Sites7 locations across Canada

Drugs / interventions tested

Conditions studied

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):

  1. 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
  2. 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
  3. 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
  4. 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
  5. 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
  6. 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
  7. 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
  8. 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:

Other trials of Enzalutamide

Trials testing the same drug.

Other recruiting trials for Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Currently open trials in the same condition.

Other British Columbia Cancer Agency trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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