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Active, not recruitingNCT04015622PROTRACTUpdated Aug 20, 2025

PROstate Cancer TReatment Optimization Via Analysis of Circulating Tumour DNA

A Phase 2 interventional study of Enzalutamide and Docetaxel in Metastatic Castration-Resistant Prostate Cancer (mCRPC), sponsored by British Columbia Cancer Agency. Active, not recruiting at 7 sites in Canada. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-20.

Sponsored by British Columbia Cancer Agency · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Apr 2026, 6 months ago, but the record still lists the study as active, not recruiting.
Phase
Phase 2
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years and older
Sex
Male
01

Study 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.

Read the 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).

02

Conditions studied

  • Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Keywords

  • circulating tumor DNA
  • Enzalutamide
  • Docetaxel
03

In context

Lead sponsor

British Columbia Cancer Agency is the lead sponsor of 149 studies on the registry; 32 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

Patients must meet ALL of the following criteria:

  1. Willing and able to provide informed consent
  2. Adult males ≥ 18 years age
  3. History of histologically confirmed adenocarcinoma of the prostate without evidence of neuroendocrine or small cell differentiation. If histology is not available, patients must have metastatic disease typical of prostate cancer (i.e., involving bone or pelvic lymph nodes or para-aortic lymph nodes) AND a serum concentration of PSA that is rising and >20ng/mL at the time prostate cancer was diagnosed clinically
  4. Consent to analysis of archival tissue collected at diagnosis is mandatory
  5. Prior surgical orchiectomy or if on LHRH agonist/antagonist then testosterone \< 1.7 nmol/L at screening visit (patients must maintain LHRH agonist/antagonist therapy for duration of study treatment if not surgically castrated)
  6. Evidence of metastatic disease on bone scan or CT scan

  7. Evidence of biochemical or imaging progression in the setting of surgical or medical castration while on abiraterone. Progressive disease for study entry is defined by one of the following three criteria as per PCWG317:

    1. PSA progression: minimum of two rising PSA values from a baseline measurement of one week interval. Minimum PSA at screening visit is 1.0 ng/mL
    2. Soft tissue or visceral disease progression: an increase ≥20% in the sum of the diameter (short axis for nodal lesions and long axis for non-nodal lesions) from the smallest sum of the diameter since treatment started, or appearance of any new lesions (see Appendix B for definition of measurable disease as per RECIST 1.1 criteria).
    3. Bone progression: ≥ 2 new lesions on bone scan confirmed on subsequent bone scan at least 8 weeks apart (2+2 rule as per PCWG317)
  8. ECOG performance status 0-2 (see Appendix C)
  9. Prior treatment with abiraterone, in either castration-sensitive or castration-resistant setting.
  10. Eligible for treatment with either enzalutamide or docetaxel as per standard of care guidelines

  11. Adequate organ function defined as:

    1. Absolute neutrophil count ≥ 1.5 x 109/L, platelet count ≥ 100 x 109/L and hemoglobin ≥ 90 g/L
    2. Creatinine clearance ≥ 30 ml/min (calculated by Cockcroft-Gault formula, see Appendix D)
    3. Total bilirubin ≤ 1.5 x upper limit of normal (ULN) except for patients with known Gilbert's syndrome (direct bilirubin ≤ 1.5 x ULN)
    4. Alanine aminotransferase (ALT) ≤ 5 x ULN
  12. Able to swallow study drug and comply with study requirements including provision of peripheral blood samples at specified time points for correlative studies
  13. Recovery from all prior treatment-related toxicity to grade ≤ 2 (as per CTCAE 5.0)

Exclusion criteria

EXCLUSION CRITERIA

Patients must NOT meet any of the following criteria:

  1. Severe concurrent illness or co-morbid disease that would make the subject unsuitable for enrolment
  2. Prior therapy with enzalutamide or other experimental anti-androgens (e.g. ARN-509, TOK-001)
  3. Prior systemic chemotherapy with docetaxel or cabazitaxel (with the exception of: patients who were treated with docetaxel for castration sensitive disease and did not progress for at least 12 months after completion of docetaxel)
  4. Active concurrent malignancy (with the exception of non-melanomatous skin cancer, or other solid tumours curatively treated with no evidence of disease for ≥3 years)
  5. Wide-field radiotherapy or radioisotopes such as Strontium-89, or Radium-223 ≤ 28 days prior to starting study drug (limited-field palliative radiotherapy for up to 5 fractions prior to starting study drug is permitted)
  6. Brain metastases or active epidural disease (treated epidural disease is permitted)
  7. Contraindication to prednisone therapy including poorly controlled diabetes mellitus
  8. History of seizure or seizure disorder, or history of any cerebrovascular event within 6 months of study entry.
  9. Uncontrolled hypertension Grade ≥3 (i.e. systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg)
  10. Gastrointestinal disorder affecting absorption
  11. Major surgery within 4 weeks of starting study treatment
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    A: Biomarker directed Therapy (BT)

    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).

    Drug: Enzalutamide · Drug: Docetaxel

  • Active comparator
    B: Clinician's Choice (CC)

    Enzalutamide or docetaxel until disease progression, then cross-over to the other therapy (e.g., enzalutamide to docetaxel, or docetaxel to enzalutamide).

    Drug: Enzalutamide · Drug: Docetaxel

Interventions

  • DrugEnzalutamide

    Enzalutamide 160 mg PO OD

    Also known as: Xtandi

  • DrugDocetaxel

    Docetaxel 75 mg/m2 IV every 3 weeks

    Also known as: Taxotere

06

What researchers measure

Primary outcomes

  1. Progression free survival (PFS)

    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

    Time frame: 1 year

Secondary outcomes

  1. Objective response

    To determine the objective response as per RECIST 1.1 in patients treated with biomarker directed therapy vs. clinician's choice.

    Time frame: 1 year

  2. PSA response rate

    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.

    Time frame: 1 year

  3. Second progression free survival (PFS2)

    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.

    Time frame: 1 year

  4. Overall survival (OS)

    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.

    Time frame: 2 years

  5. Clinical benefit rate (CBR)

    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).

    Time frame: 3 months

  6. Correlation of specific ctDNA-based genomic alterations to treatment response

    Among mCRPC patients receiving enzalutamide and docetaxel

    Time frame: 1 year

07

Study locations

7 sites
  • BC Cancer - Kelowna (Sindi Ahluwalia Hawkins Centre)
    Kelowna, British Columbia V1Y 5L3, Canada
  • BC Cancer - Centre for the North
    Prince George, British Columbia V2M 7E9, Canada
  • BC Cancer - Surrey Centre
    Surrey, British Columbia V3V 1Z2, Canada
  • Sunnybrook Health Sciences Centre
    Toronto, British Columbia M4N 3M5, Canada
  • BC Cancer - Vancouver Centre
    Vancouver, British Columbia V5Z 4E6, Canada
  • BC Cancer - Victoria Centre
    Victoria, British Columbia V8R 6V5, Canada
  • London Health Sciences Centre
    London, Ontario N6A 5W9, Canada
08

References and documents

Publications

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09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 20, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04015622
Lead sponsor
British Columbia Cancer Agency
Responsible party
Sponsor
First posted
Jul 11, 2019
Start date
Oct 7, 2020
Primary completion
Apr 1, 2026 (estimated)
Completion
Dec 1, 2026 (estimated)
Last update
Aug 20, 2025

Study contacts

Kim N Chi, MD
study chair · British Columbia Cancer Agency

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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