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Hormone-Resistant Prostate CancerPhase 2NCT01503229

Abiraterone Acetate in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer

A Phase 2 study testing Abiraterone Acetate, Laboratory Biomarker Analysis and Pharmacological Study in people with Hormone-Resistant Prostate Cancer and Metastatic Prostate Carcinoma, run by University of Washington at 1 site 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

This phase II trial studies how well abiraterone acetate works in treating patients with hormone-resistant prostate cancer that has spread from the primary site (place where it started) to other places in the body (metastatic). Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Abiraterone Acetate, Laboratory Biomarker Analysis and Pharmacological Study
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteUnited States
Study dates
Dec 2012to 12 Mar 2020
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

  • Have signed an informed consent document indicating that the subjects understands the purpose of and procedures required for the study and are willing to participate in the study
  • Written authorization for use and release of health and research study information has been obtained
  • Be willing/able to adhere to the prohibitions and restrictions specified in this protocol
  • Able to swallow the study drug whole as a tablet
  • 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
  • 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
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  • Histologically proven adenocarcinoma of the prostate
  • Eastern Cooperative Oncology Group (ECOG) performance status =< 2
  • Metastatic castration resistant prostate cancer as defined by serum testosterone < 50 ng/ml and one of the following:
  • Prostate specific antigen (PSA) level of at least 2 ng/ml that has risen on at least 2 successive occasions at least 1 week apart
  • Evaluable disease progression by modified RECIST (Response Evaluation Criteria in Solid Tumors)
  • Progression of metastatic bone disease on bone scan with > 2 new lesions
  • Maintenance of Lupron or antagonist unless previously treated with orchiectomy
  • The presence of metastatic disease amenable to computed tomography (CT) or ultrasound guided biopsy; this may include thoracolumbar vertebral bodies, pelvis, femur or humerus, or soft tissue or nodal metastasis amenable to biopsy (excluding lung or pleural lesions)
  • Patients may have received secondary hormonal manipulations (excluding prior abiraterone acetate, MDV3100 or TAK700) or up to two lines of chemotherapy; all prior therapy except Lupron must have been discontinued for more than 4 weeks before enrollment
  • Serum potassium of >= 3.5 mEq/L
  • Aspartate aminotransferase (AST), alanine aminotransferase (ALT) < 1.5 x upper limit of normal (ULN)
  • Bilirubin levels < 1.5 x ULN
  • Serum albumin of >= 3.0 g/dL
  • Total bilirubin =< 1.5 x ULN
  • Calculated creatinine clearance >= 60 mL/min
  • Platelet count of >= 100,000/uL
  • Absolute neutrophil count of > 1,500 cell/mm^3
  • Hemoglobin >= 9.0 g/dL

Who cannot join

  • Active infection or other medical condition that would make prednisone/prednisolone (corticosteroid) use contraindicated
  • Patients who are currently receiving active therapy for other neoplastic disorders will not be eligible
  • Patients with histologic evidence of small cell carcinoma of the prostate will not be eligible
  • Known brain metastasis
  • Uncontrolled hypertension (systolic blood pressure [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
  • Active or symptomatic viral hepatitis or chronic liver disease
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  • 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 medical therapy
  • Administration of an investigational therapeutic within 30 days of screening
  • Patients with dementia/psychiatric illness/social situations that would limit compliance with study requirements or would prohibit the understanding and/or giving of informed consent will not be eligible
  • Patients with any condition that, in the opinion of the investigator, would compromise the well-being of the subject or the study or prevent the subject from meeting or performing study requirements
  • Patients requiring therapeutic anticoagulation (e.g., warfarin, dabigatran, heparin, or low molecular weight heparins [Lovenox, dalteparin])
  • Patients with poorly controlled diabetes
  • Patients with a history of gastrointestinal disorders (medical disorders or extensive surgery) that may interfere with the absorption of the study agents
  • Patients with a pre-existing condition that warrants long-term corticosteroid use in excess of study dose
  • Patients with known allergies, hypersensitivity, or intolerance to abiraterone acetate or prednisone or their excipients
  • Child-Pugh class B or C hepatic impairment

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Fred Hutch/University of Washington Cancer Consortium

    Seattle, Washington, 98109

Other trials in United States

About this study

Official title: Open Label Pharmacodynamic Study of Abiraterone Acetate in the Treatment of Metastatic, Castration Resistant Prostate Cancer

This phase II trial studies how well abiraterone acetate works in treating patients with hormone-resistant prostate cancer that has spread from the primary site (place where it started) to other places in the body (metastatic). Abiraterone acetate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To determine the magnitude of tissue testosterone suppression by abiraterone acetate in metastatic castrate-resistant prostate cancer (CRPC) (resistant to luteinizing hormone-releasing hormone [LHRH] agonist or orchiectomy ± antiandrogen) after one month of treatment to establish tissue based mechanism of action.

OUTLINE:

Patients receive abiraterone acetate orally once daily and prednisone twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up periodically.

Being tested
Abiraterone Acetate, Laboratory Biomarker Analysis, Pharmacological Study, Prednisone
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • Abiraterone AcetateDrug

    Also called CB7630, Zytiga

    Given by mouth

  • Laboratory Biomarker AnalysisOther

    Correlative studies

  • Pharmacological StudyOther

    Correlative studies

  • PrednisoneDrug

    Also called .delta.1-Cortisone, 1, 2-Dehydrocortisone, Adasone, Cortancyl

    Given PO

Study groups in NCT01503229
Study groupRoleWhat they receive
Treatment (abiraterone acetate and prednisone)ExperimentalPatients receive abiraterone acetate orally once daily and prednisone orally twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Receives: Drug: Abiraterone Acetate; Other: Laboratory Biomarker Analysis; Other: Pharmacological Study; Drug: Prednisone

What is being measured

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

  1. Change in Tissue Testosterone and Dihydrotestosterone

    Tissue testosterone will be measured in biopsy tissues

    Measured: From baseline to week 4

Timeline

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

  1. First posted2 Jan 2012 (estimated)
  2. Study startDec 2012
  3. Primary completion12 Mar 2020
  4. Study completion12 Mar 2020

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
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01503229
Sponsor's protocol ID
7639
Other IDs
NCI-2011-03745, 0801, 7639, P30CA015704
Status last verified
Apr 2021
First submitted
27 Dec 2011
Last updated
14 May 2021

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Abiraterone Acetate, Laboratory Biomarker Analysis and Pharmacological Study in people with Hormone-Resistant Prostate Cancer and Metastatic Prostate Carcinoma, run by University of Washington at 1 site 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 24 inclusion and 18 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 14 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 14 May 2021). 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?

Change in Tissue Testosterone and Dihydrotestosterone (time frame: From baseline to week 4). 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 NCT01503229.

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 14 May 2021.

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