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Prostate CancerPhase 2NCT01940276

Abiraterone Race in Metastatic Castrate-resistant Prostate Cancer

A Phase 2 study testing Abiraterone acetate and Prednisone in people with Prostate Cancer, run by Duke University at 14 sites in United States.

Completed

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

Official record
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Trial summary

The primary goal is to prospectively estimate the median radiographic PFS of African American and Caucasian men with mCRPC to abiraterone acetate and prednisone. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Abiraterone acetate and Prednisone
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
14 sitesUnited States
Study dates
Oct 2013to 8 Oct 2019
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Male, age ≥ 18 years
  • Karnofsky performance status ≥ 70
  • Life expectancy of ≥ 12 months
  • Willing to take abiraterone acetate on an empty stomach; no food should be consumed at least two hours before and for at least one hour after the dose of abiraterone acetate is taken, and should be able to swallow tablets whole, without crushing/chewing tablets
  • 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 1 week after last dose of abiraterone acetate
  • Adequate laboratory parameters
Show all 19Show fewer
  • Histologically confirmed diagnosis of adenocarcinoma of the prostate. Histologic variants of prostate cancer, including neuroendocrine features and small cell carcinoma of the prostate are excluded
  • Radiographic evidence of metastatic disease; evaluable non-target lesions and/or bone only metastasis are permitted
  • Ongoing ADT using an LHRH agonist (e.g. leuprolide, goserelin) or antagonist (e.g. degarelix) must continue on therapy unless prior bilateral orchiectomy has been performed. Screening serum testosterone must be <50 ng/dl
  • PSA ≥ 2.0 ng/mL
  • Evidence of of castration resistant disease on ADT as evidenced by one of the following:
  • Absolute rise in PSA of 2.0 ng/mL or greater, minimum 2 consecutive rising PSA levels with an interval of ≥ 1 week between each PSA level, OR
  • 2 consecutive PSA levels 50% or greater above the PSA nadir achieved on ADT and separated at least 1 week apart, OR
  • CT or MRI based evidence of disease progression (soft tissue, nodal or visceral disease progression) according to modified PCWG2 criteria or modified RECIST 1.1 criteria, or at least 1 new bone scan lesion as compared to the most immediate prior radiologic studies)
  • A minimum of 2 weeks elapsed off of antiandrogen therapy prior to start of study drug (i.e. flutamide, nilutamide, bicalutamide)
  • A minimum of 4 weeks elapsed off of sipuleucel-T prior to start of study drug
  • A minimum of 4 weeks from any major surgery prior to start of study drug
  • Self-reported race of either African American or Caucasian
  • Ability to swallow, retain, and absorb oral medication

Who cannot join

  • Prior treatment with abiraterone acetate or enzalutamide
  • Active infection or other medical condition that would make prednisone/prednisolone (corticosteroid) use contraindicated
  • Any chronic medical condition requiring a higher dose of corticosteroid than 5mg prednisone/prednisolone bid
  • Have known allergies, hypersensitivity, or intolerance to abiraterone acetate or prednisone or their excipients
  • Pathological finding consistent with small cell carcinoma of the prostate
  • Symptomatic Liver or visceral organ metastasis
Show all 20Show fewer
  • Have a history of gastrointestinal disorders (medical disorders or extensive surgery) that may interfere with the absorption of the study agents
  • Known brain metastasis
  • Prior cytotoxic chemotherapy or biologic therapy for the treatment of CRPC
  • Previously treated with ketoconazole for prostate cancer for greater than 7 days
  • Prior systemic treatment with an azole drug (e.g. fluconazole, itraconazole) within 4 weeks of Cycle 1, Day 1
  • Uncontrolled hypertension (systolic BP ≥ 160 mmHg or diastolic BP ≥ 95 mmHg). Patients with a history of hypertension are allowed provided blood pressure is controlled by anti-hypertensive treatment.
  • Poorly controlled diabetes
  • Active or symptomatic viral hepatitis or chronic liver disease
  • History of pituitary or adrenal dysfunction
  • Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association (NYHA) Class II-IV heart disease or cardiac ejection fraction measurement of < 50% at baseline
  • Atrial Fibrillation or other cardiac arrhythmia requiring therapy
  • Other malignancy, except non-melanoma skin cancer, with a ≥ 30% probability of recurrence within 24 months
  • Administration of an investigational therapeutic within 30 days of Cycle 1, Day 1
  • Any condition which, in the opinion of the investigator, would preclude participation in this trial

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

United States14 sites

  • Birmingham VA Medical Center

    Birmingham, Alabama, 35233

  • University of North Carolina

    Chapel Hill, North Carolina, 27599

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Virginia Oncology Associates

    Hampton, Virginia, 23666

  • Maria Parham Medical Center

    Henderson, North Carolina, 27536

  • Scotland Memorial Hospital

    Laurinburg, North Carolina, 28352

  • Southeastern Regional

    Lumberton, North Carolina, 28359

  • Tulane Cancer Center

    New Orleans, Louisiana, 70112

  • Duke Raleigh Hospital

    Raleigh, North Carolina, 27609

  • W. G. 'Bill' Hefner VA Medical Center

    Salisbury, North Carolina, 28144

  • Johnston Memorial Hospital

    Smithfield, North Carolina, 27577

  • Spartanburg Regional

    Spartanburg, South Carolina, 29303

  • Wake Forest University

    Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

Official title: A Phase II Open-label, Parallel Group Study of Abiraterone Acetate Plus Prednisone in African American and Caucasian Men With Metastatic Castrate-resistant Prostate Cancer

The primary goal is to prospectively estimate the median radiographic PFS of African American and Caucasian men with mCRPC to abiraterone acetate and prednisone.

Read the detailed description

This is a non-comparative pilot open-label, parallel arm, multicenter study of abiraterone acetate in African American and Caucasian men with mCRPC. Patients will self-report on race and 50 patients will be enrolled into each group. Patients will be treated on open-label treatment until evidence of disease progression as defined by Prostate Cancer Working Group Two (PCWG2) definition or until two years at which point they will roll over to the standard of care at that time. The study agent abiraterone acetate will be administered by the patient at a dose of 1000mg orally once daily with prednisone 5 mg BID in 4-week cycles throughout the treatment period.

Conditions
Prostate Cancer
Being tested
Abiraterone acetate, Prednisone
Keywords
Prostate cancer, metastatic, castrate resistant, abiraterone acetate, prednisone, metastatic prostate cancer
Medical subject headings
Prostatic Neoplasms, Neoplasm Metastasis

What participants receive

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

  • Abiraterone acetateDrug

    Also called Zytiga

  • PrednisoneDrug

Study groups in NCT01940276
Study groupRoleWhat they receive
Abiraterone Acetate and PrednisoneExperimentalabiraterone acetate will be administered by the patient at a dose of 1000mg orally once daily with prednisone 5 mg BID in 4-week cycles
Receives: Drug: Abiraterone acetate; Drug: Prednisone

What is being measured

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

  1. Median Radiographic Progression Free Survival (PFS)

    Time in months from the start of study treatment to the date of first progression according to Prostate Cancer Working Group 2 criteria, or to death due to any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Patients alive who had not progressed as of the last follow-up had PFS censored at the last follow-up date. Median rPFS was estimated using a Kaplan-Meier curve.

    Measured: up to 2 years

Secondary outcomes (5)

  1. Change in PSA Response

    Percent of men with Prostate Specific Antigen (PSA) declines > 30%, > 50% and > 90%

    Measured: Baseline and up to 2 years

  2. Median Time to PSA Progression

    Time to PSA progression as defined by PCWG 2 criteria is the date that a 25% or greater increase and an absolute increase of 2 ng/mL or more from the nadir is documented, which is confirmed by a second value obtained 3 or more weeks later.

    Measured: up to 2 years

  3. Number of Men With PSA Decline to < 0.1 and < 0.2 ng/ml

    Number of men who achieve a PSA decline to < 0.1 and < 0.2 ng/ml

    Measured: up to 2 years

  4. Percent of Subjects Experiencing Hypertension

    Incidence and grade of hypertension in the two populations. (Grade 1: Systolic BP 120 to 139 mmHg or diastolic BP 80 to 89 mmHg, Grade 2: Systolic BP 140 to 159 mmHg or diastolic BP 90 to 99 mmHg, Grade 3: Systolic BP ≥160 mmHg or diastolic BP ≥100 mmHg, Grade 4: Life-threatening consequences, urgent intervention indicated)

    Measured: up to 2 years

  5. Overall Survival

    Length of patient's life after starting study

    Measured: up to 3 years

Timeline

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

  1. First posted12 Sep 2013 (estimated)
  2. Study startOct 2013
  3. Primary completion8 Oct 2019
  4. Study completion8 Oct 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
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01940276
Sponsor's protocol ID
Pro00046383
Other IDs
212082PCR2018
Status last verified
Nov 2020
First submitted
9 Sep 2013
Last updated
9 Dec 2020
Data monitoring committee
No

Publications

  • Piwarski SA, Howard LE, Paul MA, Bachelder N, LaCroix B, Clayton A, Allen D, Kephart J, Armstrong AJ, Patierno SR, George DJ, Hyslop T, Freedman JA. Genetic ancestry-concordant ceramide metabolism and response to androgen receptor pathway inhibition in metastatic castration-resistant prostate cancer. Cancer. 2026 Jun 1;132(11):e70371. doi: 10.1002/cncr.70371.

    PubMed 42186347

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Abiraterone acetate and Prednisone in people with Prostate Cancer, run by Duke University at 14 sites in United States.

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 19 inclusion and 20 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 9 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in United States. 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?

Yes. Results are posted in the registry (first posted 9 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Median Radiographic Progression Free Survival (PFS) (time frame: up to 2 years). 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 NCT01940276, which also lists 1 linked publication.

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 9 Dec 2020.

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