- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02429193
Biomarkers of Androgen Response and Resistance In Evolution During a Rising PSA (BARRIER-P)
January 10, 2020 updated by: University Health Network, Toronto
An Open-label Phase 2 Multi-center Study of Enzalutamide and Abiraterone and Biomarkers of Androgen Response and Resistance During Rising PSA: BARRIER-P Trial
This is an open-label phase 2 multi-center study of abiraterone and enzalutamide in men with castration-resistant prostate cancer.
Sixteen patients will be enrolled over 18 months.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
16
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
British Columbia
-
Vancouver, British Columbia, Canada, V5Z 4E6
- British Columbia Cancer Agency, Vancouver Cancer Centre
-
-
Ontario
-
Toronto, Ontario, Canada, M5G 2M9
- Princess Margaret Cancer Centre
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Patients with histologically or cytologically confirmed prostate cancer
- Able to read and understand the consent form, either alone or with the aid of a translator
- Surgically or medically castrated, with testosterone levels of < 50 ng/dL (< 2.0 nmol/L). If the patient is being treated with luteinizing hormone-releasing hormone (LHRH) agonists (patients who have not undergone orchiectomy), they must remain on continuous androgen suppression therapy throughout the study
- Patients receiving bone-targeted therapies must be on stable doses for at least 4 weeks prior to enrollment
- Historical frozen/paraffin-embedded diagnostic tissue specimens are available for analysis (i.e. radical prostatectomy or biopsy tissue)
- Documented metastatic disease by positive bone scan or metastatic lesions (on CT or MRI) that can be biopsied with an anticipated minimum of 4 cores, as assessed by the local radiologist
- prostate cancer progression at study entry defined as one or more of the following criteria: i. Rising PSA: minimum of two rising PSA levels with an interval of ≥ 1 week between each determination ii. Soft tissue disease progression, as defined by RECIST 1.1 iii. Bone disease progression, as defined by PCWG2 with two or more new lesions on bone scan
- PSA value at screening visit ≥ 2 µg/L (2 ng/mL)
- ECOG performance status 0-2
Adequate organ and BM function, as defined by the following criteria:
i. absolute neutrophil count ≥1,500/µL ii. platelets ≥100,000/µL iii. total bilirubin ≤1.5 × institutional upper limit of normal (ULN) iv. AST(SGOT) or ALT(SGPT) ≤2.5 × institutional ULN v. creatinine ≤1.5 × institutional ULN or below
- Serum albumin ≥ 3.0 g/dL
- Serum potassium ≥ 3.5 mmol/L
- Haemoglobin ≥ 10.0 g/dL, independent of transfusion
- Asymptomatic or mildly symptomatic from prostate cancer
- Life expectancy of > 6 months
- Able to swallow study drugs
- Patients who have partners of childbearing potential must be willing to use a method of birth control with adequate barrier protection as determined to be acceptable by the principal investigator and sponsor during the study and for 13 weeks after last study drug administration
Exclusion Criteria:
- Patients with known hypersensitivity or allergy to abiraterone acetate, enzalutamide or any of their excipients.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, congestive heart failure (NYHA Class 3 or greater), cirrhosis with a Child-Pugh level of B or greater or evidence of cardiac dysfunction, unstable angina pectoris, cardiac arrhythmia, myocardial infarction within 6 months, hypotension (defined by systolic blood pressure < 86 mmHg at Screening visit), hypertension (defined by systolic blood pressure > 170 mmHg or diastolic blood pressure > 105 mmHg at Screening visit), bradycardia (defined by < 50 beats per minute on ECG performed at screening), active peptic ulcer disease, clinically significant gastrointestinal conditions (e.g. Crohns disease, ulcerative colitis), any seizure disorder or psychiatric illness, and social situations that would limit compliance with study requirements
- Active invasive malignancy at any other site excluding squamous cell or basal cell carcinomas of the skin
- Known or suspected brain metastasis or leptomeningeal disease
- Radiotherapy within the past 4 weeks, except for low dose palliative radiation to bone of ≤5 fractions
- Treatment with 5-α reductase inhibitors (finasteride, dutasteride), androgen receptor antagonists (bicalutamide, nilutamide, flutamide), estrogens, cyproterone within 4 weeks of Day 1 visit
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Abiraterone / enzalutamide
Abiraterone + prednisone; Enzalutamide
|
Abiraterone acetate (1000 mg/day p.o.) + prednisone (5 mg b.i.d., p.o.)
Other Names:
Enzalutamide (160 mg/day p.o.)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in expression of androgen receptor abnormalities (e.g. ARV7, AR mutations) following abiraterone/enzalutamide treatment
Time Frame: 18 months
|
The change in protein expression of androgen receptor (AR7) splice variant and AR / AR pathway mutations as a mechanism of resistance to abiraterone/enzalutamide is evaluated by measuring the difference in a quantitative immunohistochemical biomarker between assays performed before and after treatment.
|
18 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of PSA increase
Time Frame: 18 months
|
18 months
|
|
Time to PSA progression
Time Frame: 18 months
|
PSA progression is defined as a ≥ 25% increase and an absolute increase of ≥ 2 µg/L (2 ng/mL) above the nadir.
|
18 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants with adverse events from the administration of abiraterone, enzalutamide, and prednisone to men with early stage prostate cancer.
Time Frame: 18 months
|
The number of participants experiencing adverse events will be evaluated to determine the safety of abiraterone, enzalutamide, and prednisone treatment in men with early stage prostate cancer, .
|
18 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Anthony Joshua, MD,MBBS,PhD,FRACP, University Health Network, Toronto
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2016
Primary Completion (Actual)
September 1, 2019
Study Completion (Actual)
September 1, 2019
Study Registration Dates
First Submitted
March 25, 2015
First Submitted That Met QC Criteria
April 23, 2015
First Posted (Estimate)
April 29, 2015
Study Record Updates
Last Update Posted (Actual)
January 13, 2020
Last Update Submitted That Met QC Criteria
January 10, 2020
Last Verified
January 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Genital Neoplasms, Male
- Prostatic Diseases
- Prostatic Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Cytochrome P-450 Enzyme Inhibitors
- Hormone Antagonists
- Steroid Synthesis Inhibitors
- Prednisone
- Abiraterone Acetate
Other Study ID Numbers
- BARRIER-P
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Castration-resistant Prostate Cancer
-
Nuvation Bio Inc.WithdrawnProstate Cancer | Prostate Neoplasm | Cancer of the Prostate | Prostatic Cancer | Castrate Resistant Prostate Cancer | Cancer of Prostate | Castration Resistant Prostatic Cancer | Castration Resistant Prostatic NeoplasmsUnited States
-
Janux TherapeuticsRecruitingProstate Cancer | Metastatic Castration-resistant Prostate Cancer | Castration Resistant Prostatic CancerUnited States, Australia
-
Universität des SaarlandesRecruitingProstate Cancer Metastatic | Advanced Prostate Carcinoma | Castration Resistant Prostatic CancerGermany
-
Myovant Sciences GmbHRecruitingMetastatic Castration-Resistant Prostate Cancer | Metastatic Castration-Sensitive Prostate Cancer | Non-Metastatic Castration-Resistant Prostate CancerUnited States
-
Massachusetts General HospitalBayerCompletedProstate Cancer | Castration-resistant Prostate Cancer | Castration-resistant Prostate Cancer Metastatic to BoneUnited States
-
Astellas Pharma IncPfizerCompletedCastration-resistant Prostate CancerJapan
-
University Hospital, GrenobleTerminatedCastration-resistant Prostate CancerFrance
-
Sidney Kimmel Comprehensive Cancer Center at Johns...Clarus TherapeuticsRecruitingProstate Cancer | Castration-resistant Prostate Cancer | Metastatic Castration-resistant Prostate CancerUnited States
-
BAMF HealthRecruitingMetastatic Castration-resistant Prostate CancerUnited States
-
Translational Research Center for Medical Innovation...CompletedCastration Resistant Prostate Cancer (CRPC)
Clinical Trials on Abiraterone + prednisone
-
Universität des SaarlandesCompleted
-
Jiangsu HengRui Medicine Co., Ltd.RecruitingMetastatic Castration-Resistant Prostate Cancer (mCRPC)Korea, Republic of, United States, Spain, France, Belgium, China, Taiwan, United Kingdom, Australia, Czechia, Hungary, Poland, Russian Federation
-
Jiangsu HengRui Medicine Co., Ltd.Not yet recruitingHigh-volume, Metastatic, Hormone-sensitive Prostate Cancer (mHSPC)
-
Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator...Active, not recruitingProstate CancerUnited States
-
ExelixisTerminatedProstatic Neoplasms | Prostate Cancer | Castration Resistant Prostate CancerUnited States
-
Janssen Research & Development, LLCCompletedProstate CancerChina, Malaysia, Russian Federation, Thailand
-
Sidney Kimmel Cancer Center at Thomas Jefferson...Millennium: The Takeda Oncology CompanyCompletedRecurrent Prostate Cancer | Hormone-resistant Prostate Cancer | Adenocarcinoma of the Prostate | Stage IV Prostate CancerUnited States
-
Hongqian GuoFirst Affiliated Hospital of Zhejiang University; Nanjing First Hospital, Nanjing... and other collaboratorsRecruitingNeoadjuvant TherapyChina
-
Alliance for Clinical Trials in OncologyNational Cancer Institute (NCI); Astellas Pharma US, Inc.; Medivation, Inc.; Biologics...Active, not recruitingRecurrent Prostate Cancer | Hormone-resistant Prostate Cancer | Adenocarcinoma of the Prostate | Stage IV Prostate CancerUnited States, Canada, Puerto Rico
-
Janssen Research & Development, LLCCompletedProstate NeoplasmsCanada, France, Poland, Ukraine, United Kingdom, China, Belgium, Spain, Argentina, Colombia, Israel, Mexico, Portugal, Bulgaria, Germany, Malaysia, Romania, South Africa, Turkey, Korea, Republic of, Japan, Australia, Netherlands, Sweden, New Zealand and more