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Castration-resistant Prostate CancerPhase 2NCT01543776

Food Effect Study of Abiraterone Acetate for Treatment of Patients With Castration-Resistant Prostate Cancer

A Phase 2 study testing abiraterone acetate in people with Castration-resistant Prostate Cancer and Stage IV Prostate Cancer, run by University of Chicago at 6 sites in 2 countries.

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 randomized phase II trial studies the best way to give abiraterone acetate in treating patients with castration-resistant prostate cancer. Abiraterone acetate is effective in treating castrate resistant prostate cancer and is taken in the fasting state. Read more about this study

Who is it for?
Any age, men only
What is being tested?
abiraterone acetate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
6 sitesin 2 countries
Study dates
Jan 2012to Dec 2017
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 Any age
  • Men only
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Histologically or cytologically confirmed prostate cancer with progressive disease defined as either:
  • 2 or more new lesions on bone scan or
  • Progressive disease on computed tomography (CT)/magnetic resonance imaging (MRI) according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria or
  • Rising prostate-specific antigen (PSA): PSA evidence for progressive prostate cancer consists of a minimum PSA level of at least 2 ng/ml, which has subsequently risen on at least 2 successive occasions, at least 2 weeks apart
  • Evidence of castration resistance defined as disease progression despite a testosterone level < 50 ng/dL (or surgical castration)
  • Any prior therapy for castrate disease is acceptable except prior abiraterone, which is excluded; a minimum washout of 28 days for any other anticancer therapy prior to first dose of study drug is required
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  • Any other radiotherapy or radionuclide require 28-day washout prior to first dose of study drug
  • Denosumab or zoledronic acid are allowed
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Total bilirubin =< 1.5 x the upper limit of normal
  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase [SGPT]) =< 2.5 X institutional upper limit of normal
  • Ability to understand and the willingness to sign a written informed consent document

Who cannot join

  • Therapy with other hormonal therapy, including any dose of megestrol acetate (Megace), finasteride (Proscar), dutasteride (Avodart), or any herbal product known to decrease PSA levels (e.g., saw palmetto and PC-SPES), or any systemic corticosteroid (other than prednisone =< 10 mg/day) within 4 weeks prior to first dose of study drug
  • Therapy with supplements or complementary medicines/botanicals within 4 weeks of first dose of study drug is excluded with the following exceptions:
  • Conventional multivitamin supplements
  • Selenium
  • Lycopene
  • Soy supplements
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  • Inability to swallow capsules or known gastrointestinal malabsorption
  • History of other malignancies, with the exception of adequately treated non-melanoma skin cancer or adequately treated superficial bladder cancer or other solid tumors curatively treated with no evidence of disease for >= 5 years from enrollment
  • Blood pressure that is not controlled despite > 2 oral agents (systolic blood pressure [SBP] > 160 and diastolic blood pressure [DBP] > 90 documented during the screening period with no subsequent blood pressure readings < 160/100)
  • Serum potassium (K)+ < 3.5 mmoL/L on more than one reading within the screening period
  • Serious intercurrent infections or non-malignant medical illnesses that are uncontrolled
  • Active psychiatric illness/social situations that would limit compliance with protocol requirements
  • New York Heart Association (NYHA) class II, NYHA class III, or IV congestive heart failure (any symptomatic heart failure)
  • Concurrent therapy with strong inhibitors or inducers of Cytochrome P450 (CYP)3A4 due to concerning possible drug-drug interactions with abiraterone

Trial locations and contacts

6 sites in 2 countries.

6 sites in 2 countries

United States5 sites

  • Emory University Winship Cancer Institute

    Atlanta, Georgia, 30322

  • University of Chicago

    Chicago, Illinois, 60637-1470

  • North Shore University Health System

    Evanston, Illinois, 60201

  • Ingalls Memorial Hospital

    Harvey, Illinois, 60430

  • Illinois Cancer Care

    Peoria, Illinois, 61615

Other trials in United States

Singapore1 site

  • National University Hospital

    Singapore

Other trials in Singapore

About this study

Official title: A Prospective Randomized Pilot Study Evaluating the Food Effect on the Pharmacokinetics and Pharmacodynamics of Abiraterone Acetate in Men With Castrate Resistant Prostate Cancer

This randomized phase II trial studies the best way to give abiraterone acetate in treating patients with castration-resistant prostate cancer. Abiraterone acetate is effective in treating castrate resistant prostate cancer and is taken in the fasting state. However, the body's absorption of abiraterone is increased with food intake. This study will test the whether a lower dose of abiraterone taken with food has a similar effect on prostate specific antigen (PSA) compared to full dose taken fasting.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To compare the pharmacodynamic effect of reduced dose (250mg daily) abiraterone acetate in the prandial state (250mg-Fed) to the full, standard 1000mg daily dose in the fasting state (1000mg-Fasting) as assessed by change in serum prostate-specific antigen (PSA).

SECONDARY OBJECTIVES:

  1. To evaluate the effect of prandial states on plasma levels and the intra-patient pharmacokinetic variability of abiraterone acetate.

II. To evaluate the safety profile of reduced dose abiraterone acetate taken in the prandial state.

III. To evaluate the pharmacodynamic effect of reduced dose abiraterone acetate in the prandial state as assessed by reduction in the extra-gonadal androgen dihydroepiadrosterone sulfate (DHEA-S) and dihydroepiandrostenedione (DHEA).

IV. To evaluate the effect of prandial state on time to disease progression (Working group criteria).

OUTLINE: Patients are randomized to one of two treatment arms.

ARM I: Patients receive abiraterone acetate orally (PO) daily first thing in morning after an overnight fast of at least 8 hours.

ARM II: Patients receive abiraterone acetate PO daily within 30 minutes of a conventional low-fat breakfast.

In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Both arms will also be treated with prednisone 5mg twice daily.

After completion of study treatment, patients are followed up within 30 days.

Being tested
abiraterone acetate
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 PO

Study groups in NCT01543776
Study groupRoleWhat they receive
Arm I (fasting)Active comparatorPatients receive abiraterone acetate PO daily first thing in morning after an overnight fast of at least 8 hours.
Receives: Drug: abiraterone acetate
Arm II (fed)ExperimentalPatients receive abiraterone acetate PO daily within 30 minutes of a conventional low-fat breakfast.
Receives: Drug: abiraterone acetate

What is being measured

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

  1. Change in PSA Level

    Data were analyzed on a log scale: log(week 12) - log(baseline) = log ratio. Smaller (more negative) values indicate a better outcome.

    Measured: From baseline to 12 weeks

Secondary outcomes (4)

  1. Progression-free Survival (PFS)

    Time to PSA progression (25% increase from baseline), radiographic progression, or death.

    Measured: Assessed up to 3 years

  2. Adrenal Androgen Production (DHEA-S)

    Extragonadal serum adrogen

    Measured: Cycle 4 (4 months)

  3. Number of Participants With Adverse Events (AEs)

    Patients with grade 3 or higher AE (CTCAE Version 4.03)

    Measured: Assessed up to 1 year

  4. Peak Plasma Concentration of Abiraterone

    Analyzed on a log scale due to skewness of distribution

    Measured: Up to 4 months

Timeline

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

  1. First posted5 Mar 2012 (estimated)
  2. Study startJan 2012
  3. Primary completionSep 2017
  4. Study completionDec 2017

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01543776
Sponsor's protocol ID
11-0709
Other IDs
NCI-2012-00116
Status last verified
Jul 2019
First submitted
15 Feb 2012
Last updated
5 Jul 2019
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Heiss BL, Geynisman DM, Martinez E, Wong ASC, Yong WP, Szmulewitz RZ, Stadler WM. Comparison of out-of-pocket costs and adherence between the two arms of the prospective, randomized abiraterone food effect trial. Support Care Cancer. 2022 Mar;30(3):2803-2810. doi: 10.1007/s00520-021-06670-3. Epub 2021 Nov 29.

    PubMed 34845502

  • Szmulewitz RZ, Peer CJ, Ibraheem A, Martinez E, Kozloff MF, Carthon B, Harvey RD, Fishkin P, Yong WP, Chiong E, Nabhan C, Karrison T, Figg WD, Stadler WM, Ratain MJ. Prospective International Randomized Phase II Study of Low-Dose Abiraterone With Food Versus Standard Dose Abiraterone In Castration-Resistant Prostate Cancer. J Clin Oncol. 2018 May 10;36(14):1389-1395. doi: 10.1200/JCO.2017.76.4381. Epub 2018 Mar 28.

    PubMed 29590007

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing abiraterone acetate in people with Castration-resistant Prostate Cancer and Stage IV Prostate Cancer, run by University of Chicago at 6 sites in 2 countries.

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 12 inclusion and 14 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 5 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States, Singapore. 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 5 Jul 2019). 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 PSA Level (time frame: From baseline to 12 weeks). 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 NCT01543776, which also lists 2 linked publications.

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 5 Jul 2019.

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