AzTrials
AzTrials

Castration-resistant Prostate CancerPhase 2BARRIER-PNCT02429193

Biomarkers of Androgen Response and Resistance In Evolution During a Rising PSA

A Phase 2 study testing Abiraterone + prednisone and Enzalutamide in people with Castration-resistant Prostate Cancer, run by University Health Network, Toronto at 2 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Castration-resistant Prostate Cancer
What is being tested?
Abiraterone + prednisone and Enzalutamide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
2 sitesCanada
Study dates
Mar 2016to 1 Sep 2019
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 18Show fewer
  • 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:
  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

Canada2 sites

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9

  • British Columbia Cancer Agency, Vancouver Cancer Centre

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

About this study

Official title: 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.

Being tested
Abiraterone + prednisone, Enzalutamide

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Abiraterone + prednisoneDrug

    Also called abiraterone acetate, Zytiga, prednisone

    Abiraterone acetate (1000 mg/day p.o.) + prednisone (5 mg b.i.d., p.o.)

  • EnzalutamideDrug

    Also called Xtandi

    Enzalutamide (160 mg/day p.o.)

Study groups in NCT02429193
Study groupRoleWhat they receive
Abiraterone / enzalutamideExperimentalAbiraterone + prednisone; Enzalutamide
Receives: Drug: Abiraterone + prednisone; Drug: Enzalutamide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in expression of androgen receptor abnormalities (e.g. ARV7, AR mutations) following abiraterone/enzalutamide treatment

    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.

    Measured: 18 months

Secondary outcomes (2)

  1. Rate of PSA increase

    Measured: 18 months

  2. Time to PSA progression

    PSA progression is defined as a ≥ 25% increase and an absolute increase of ≥ 2 µg/L (2 ng/mL) above the nadir.

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Apr 2015 (estimated)
  2. Study startMar 2016
  3. Primary completion1 Sep 2019
  4. Study completion1 Sep 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
16 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02429193
Sponsor's protocol ID
BARRIER-P
Acronym
BARRIER-P
Status last verified
Jan 2020
First submitted
25 Mar 2015
Last updated
13 Jan 2020
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Abiraterone + prednisone and Enzalutamide in people with Castration-resistant Prostate Cancer, run by University Health Network, Toronto at 2 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in expression of androgen receptor abnormalities (e.g. ARV7, AR mutations) following abiraterone/enzalutamide treatment (time frame: 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02429193.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in