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Prostate CancerPhase 3NCT01591122

Study of Abiraterone Acetate Plus Prednisone in Patients With Chemo-naive Metastatic Castration-Resistant Prostate Cancer

A Phase 3 study testing Abiraterone acetate and prednisone in people with Prostate Cancer, run by Janssen Research & Development, LLC at 22 sites in 4 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

The purpose of this study is to demonstrate the safety and effectiveness of abiraterone acetate when co-administered with prednisone in patients with chemo-naive metastatic castration resistant prostate Cancer (mCRPC). 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?
Yes, some participants may receive a placebo
How many people
313 participants
Where
22 sitesin 4 countries
Study dates
27 Mar 2012to 31 Jan 2019
Phase
Phase 3
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

  • Has a confirmed diagnosis of adenocarcinoma of the prostate with evidence of metastatic disease
  • Prostate cancer progression documented by PSA progression or radiographic progression
  • Asymptomatic or mildly symptomatic from prostate cancer
  • Surgically or medically castrated, with testosterone levels of <50 ng/dL
  • Previous anti-androgen therapy and progression after withdrawal
  • ECOG performance status score of 0 or 1
Show all 10Show fewer
  • If opiate analgesics for cancer-related pain, treatment must not be administered within 4 weeks of Cycle 1 Day 1
  • If radiation therapy for treatment of the primary tumor is given, treatment must not be administered within 6 weeks of Cycle 1 Day 1
  • If previously treated with ketoconazole for prostate cancer, duration of treatment must not be greater than 7 days
  • Life expectancy of at least 6 months

Who cannot join

  • Active infection or other medical condition that would make prednisone (corticosteroid) use contraindicated
  • Any chronic medical condition requiring a higher dose of corticosteroid than 5 mg prednisone twice daily
  • Pathological finding consistent with small cell carcinoma of the prostate
  • Liver or visceral organ metastasis, brain metastasis, and other malignancy, except non-melanoma skin cancer, with a 30% probability of recurrence within 24 months
  • Prior cytotoxic chemotherapy or biologic therapy for the treatment of metastatic castration-resistant prostate cancer (mCRPC)
  • Radiation or radionuclide therapy for treatment of mCRPC
  • Uncontrolled hypertension, patients with a history of hypertension are allowed provided blood pressure is controlled by anti hypertensive treatment
  • History of pituitary or adrenal dysfunction

Trial locations and contacts

22 sites in 4 countries.

22 sites in 4 countries

China10 sites

  • Study site

    Beijing

  • Study site

    Chengdu

  • Study site

    Chongqing

  • Study site

    Guangzhou

  • Study site

    Hangzhou

  • Study site

    Jinan

  • Study site

    Nanjing

  • Study site

    Shanghai

  • Study site

    Tianjin

  • Study site

    Wuhan

Other trials in China

Russia10 sites

  • Study site

    Arkhangelsk

  • Study site

    Moscow

  • Study site

    Pyatigorsk

  • Study site

    Rostov-on-Don

  • Study site

    Saint Petersburg

  • Study site

    Sochi

  • Study site

    Stavropol

  • Study site

    Ufa

  • Study site

    Yekaterinburg

  • Study site

    Yoshkar-Ola

Other trials in Russia

Malaysia1 site

  • Study site

    Kuala Lumpur

Other trials in Malaysia

Thailand1 site

  • Study site

    Bangkok

Other trials in Thailand

About this study

Official title: A Phase 3, Randomized, Double-blind, Placebo-Controlled Study of Abiraterone Acetate (JNJ-212082) Plus Prednisone in Asymptomatic or Mildly Symptomatic Patients With Metastatic Castration-Resistant Prostate Cancer

The purpose of this study is to demonstrate the safety and effectiveness of abiraterone acetate when co-administered with prednisone in patients with chemo-naive metastatic castration resistant prostate Cancer (mCRPC).

Read the detailed description

This is a multinational, multicenter, randomized (the study drug is assigned by chance), double-blind (neither physician nor patient knows the treatment that the patient receives), placebo-controlled (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial) study. All patients will be randomly assigned in a 1:1 ratio between the abiraterone acetate group (abiraterone acetate and prednisone) and the placebo group (placebo and prednisone). The study will consist of a screening phase (within 28 days prior randomization on Cycle 1, Day 1), a treatment phase (28-day cycles until disease progression), and a follow-up phase (all patients will be contacted for every 3 months up to Month 60, focusing primarily on survival status). Patients will receive either abiraterone acetate 1,000 mg daily and prednisone 5 mg twice daily or placebo and prednisone 5 mg twice daily.

Conditions
Prostate Cancer
Being tested
Placebo and prednisone, Abiraterone acetate and prednisone
Keywords
Prostate cancer, Metastatic Castration Resistant Prostate Cancer, Abiraterone acetate, Prednisone, Zytiga
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • Placebo and prednisoneDrug

    Placebo: Form=tablet, route=oral. Four tablets daily on an empty stomach. Prednisone: Type=exact number, unit=mg, number=5, form=tablet, route=oral, twice daily.

  • Abiraterone acetate and prednisoneDrug

    Abiraterone acetate: Type=exact number, unit=mg, number=250, form=tablet, route=oral. Four tablets daily on an empty stomach Prednisone: Type=exact number, unit=mg, number=5, form=tablet, route=oral, twice daily

Study groups in NCT01591122
Study groupRoleWhat they receive
Abiraterone acetate and prednisoneExperimentalNot described
Receives: Drug: Abiraterone acetate and prednisone
Placebo and prednisoneActive comparatorNot described
Receives: Drug: Placebo and prednisone

What is being measured

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

  1. Time to prostate specific antigen (PSA) progression (TTPP)

    Measured from the time interval from the date of randomization to the date of the PSA progression based on prostate cancer clinical trials working group 2 (PCWG2) criteria

    Measured: 14 months

Secondary outcomes (8)

  1. Overall survival

    The percentage of people in a study or treatment group who are alive from date of randomization to date of death

    Measured: 5 years

  2. Time to initiation of cytotoxic chemotherapy

    Date of randomization to date of initiation of chemotherapy

    Measured: 5 years

  3. Prostate specific antigen (PSA) response rate

    Proportion of patients achieving a PSA decline 50% according to prostate cancer clinical trials working group 2 (PCWG2) criteria

    Measured: 14 months

  4. Objective response rate

    Measurable disease based on modified response evaluation criteria in solid tumors (RECIST) criteria and baseline lymph node size must be 2.0 cm to be considered target or evaluable lesion for RECIST criteria

    Measured: 14 months

  5. Quality of life (QoL) total score and each subscale score

    Assessed by functional assessment of cancer therapy-prostate (FACT-P)

    Measured: 14 months

  6. Time to pain progression

    Assessed by the Brief Pain Inventory Short Form (BPI-SF) and analgesic score

    Measured: 14 months

  7. Time to Eastern Cooperative Oncology Group (ECOG) performance status score determination

    ECOG performance status score 0 (Fully active, able to carry on all pre-disease performance without restriction) versus 1 (Restricted in physically strenuous activity but ambulatory and able to carry out work on a light or sedentary nature, eg, light housework, office work)

    Measured: 14 months

  8. Collection of safety data including adverse events

    Measured: 5 years

Timeline

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

  1. First posted3 May 2012 (estimated)
  2. Study start27 Mar 2012
  3. Primary completion31 Dec 2016
  4. Study completion31 Jan 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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
313 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01591122
Sponsor's protocol ID
CR100011
Other IDs
ABI-PRO-3002
Status last verified
Jan 2020
First submitted
2 May 2012
Last updated
21 Jan 2020
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Abiraterone acetate and prednisone in people with Prostate Cancer, run by Janssen Research & Development, LLC at 22 sites in 4 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 10 inclusion and 8 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 21 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 22 sites in China, Russia, Malaysia, Thailand. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Time to prostate specific antigen (PSA) progression (TTPP) (time frame: 14 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 NCT01591122.

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 21 Jan 2020.

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Clinical Trial NCT01591122 | AzTrials