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PROstate Cancer TReatment Optimization Via Analysis of Circulating Tumour DNA | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE2

PROstate Cancer TReatment Optimization Via Analysis of Circulating Tumour DNA

A Randomized Phase II Trial Comparing Biomarker Directed Therapy Versus Clinician's Choice of Enzalutamide or Docetaxel in Patients With Advanced Prostate Cancer Post Abiraterone

NCT04015622•British Columbia Cancer Agency

View on ClinicalTrials.gov

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).

Eligibility

Age

18 - No limit years

Sex

MALE

Healthy Volunteers

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).
+11 more 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)
+2 more criteria

Locations (7)

BC Cancer - Kelowna (Sindi Ahluwalia Hawkins Centre)

Kelowna, British Columbia, Canada

BC Cancer - Centre for the North

Prince George, 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

Key Dates

Start Date

October 7, 2020

Primary Completion Date

April 1, 2026

Completion Date

December 1, 2026

Last Updated

August 20, 2025

Enrollment

100

ESTIMATED participants

Conditions

Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Interventions

Enzalutamide

DRUG

Docetaxel

DRUG

A Trial to Find Out if REGN5678 (Nezastomig) is Safe and How Well it Works Alone or in Combination With Cemiplimab for Adult Participants With Metastatic Castration-Resistant Prostate Cancer and Other Tumors

NCT03972657

Metastatic Castration-Resistant Prostate Cancer (mCRPC)Clear Cell Renal Cell Carcinoma (ccRCC)

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RECRUITINGPHASE2

Metastatic Castrate-Resistant Prostate Cancer Subjects Treated With PROVENGE® + One Infusion of Sipuleucel-T

NCT06134232

Metastatic Castration-Resistant Prostate Cancer (mCRPC)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 20, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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PROstate Cancer TReatment Optimization Via Analysis of Circulating Tumour DNA

Inclusion Criteria

Exclusion Criteria

A Trial to Find Out if REGN5678 (Nezastomig) is Safe and How Well it Works Alone or in Combination With Cemiplimab for Adult Participants With Metastatic Castration-Resistant Prostate Cancer and Other Tumors

Metastatic Castrate-Resistant Prostate Cancer Subjects Treated With PROVENGE® + One Infusion of Sipuleucel-T

A Phase II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of YL201 in Patients With mCRPC

Phase 1 Study Evaluating Safety and Tolerability of SL-T10, GX-I7, and Pembrolizumab Triple Combination in mCRPC.

68Ga-PSMA-0057 and 177Lu-PSMA-0057 in Patients With PSMA-Positive Metastatic Castration-Resistant Prostate Cancer

Lutetium (177Lu) DGUL Combined With Pembrolizumab in Metastatic Castration-Resistant Prostate Cancer