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Prostate CancerPhase 2NCT01685983

A Study of Abiraterone Acetate (JNJ-212082) and Prednisolone in Patients With Advanced Prostate Cancer

A Phase 2 study testing Abiraterone acetate and Prednisolone in people with Prostate Cancer, run by Janssen Research & Development, LLC at 8 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

The purpose of this study is to assess the safety and efficacy in Korea or Taiwan of oral abiraterone acetate and oral prednisolone in men with metastatic-castration resistant prostate cancer (mCRPC) and with disease progression following treatment with a docetaxel-containing chemotherapy. 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 Prednisolone
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
82 participants
Where
8 sitesin 2 countries
Study dates
30 Aug 2011to 6 Mar 2018
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

  • Histologically or cytologically confirmed adenocarcinoma of the prostate (stage IV)
  • Has documented Prostate Specific Antigen (PSA) progression according to protocol-specific prostate specific antigen working group (PSAWG) eligibility criteria
  • Has undergone prior chemotherapy for prostate cancer with regimen(s) containing Docetaxel
  • Has an ongoing androgen deprivation with serum testosterone less than 50 ng/dL
  • Has not received radiotherapy, chemotherapy, or immunotherapy at least 30 days prior to the treatment
  • Eastern Cooperative Oncology Group Performance Status less than or equal to 2

Who cannot join

  • Active or uncontrolled autoimmune disease that may require corticosteroid therapy
  • Serious or uncontrolled co-existent non-malignant disease, including active and uncontrolled infection
  • Uncontrolled hypertension
  • Hemoglobin less than or equal to 9.0 g/dL independent of transfusion
  • Has abnormal liver function tests
  • Surgery or local prostatic intervention within 30 days of the first dose

Trial locations and contacts

8 sites in 2 countries.

8 sites in 2 countries

South Korea4 sites

  • Study site

    Busan

  • Study site

    Cheongju-si

  • Study site

    Seongnam-Si, Gyeonggi-Do

  • Study site

    Seoul

Other trials in South Korea

Taiwan4 sites

  • Study site

    Kaohsiung City

  • Study site

    Taichung

  • Study site

    Taipei

  • Study site

    Taoyuan County

Other trials in Taiwan

About this study

Official title: A Phase 2 Open Label Study of Abiraterone Acetate (JNJ-212082) and Prednisolone in Patients With Advanced Prostate Cancer Who Have Failed Androgen Deprivation and Docetaxel-Based Chemotherapy.

The purpose of this study is to assess the safety and efficacy in Korea or Taiwan of oral abiraterone acetate and oral prednisolone in men with metastatic-castration resistant prostate cancer (mCRPC) and with disease progression following treatment with a docetaxel-containing chemotherapy.

Read the detailed description

This is an open-label (all people know the identity of the intervention), multicenter, single arm (only one treatment group) study to evaluate the efficacy and safety of abiraterone acetate in patients with mCRPC. The study will be divided into screening phase (up to 28 days before enrollment), treatment phase including treatment cycles (each cycle of treatment will be 28 days), and follow-up phase. Approximately 80 patients will be enrolled into this study. Safety evaluations for adverse events, clinical laboratory tests, electrocardiogram and vital signs as well as pharmacokinetic (what the body does to drug) assessments will be conducted in this study. Patients will continue to receive abiraterone acetate plus prednisolone until disease progression or occurrence of unacceptable toxicity.

Conditions
Prostate Cancer
Being tested
Abiraterone acetate, Prednisolone
Keywords
Prostate Cancer, Metastatic-castration resistant prostate cancer, Prostate specific antigen, Abiraterone acetate, JNJ-212082, Abiraterone, Prednisolone, Androgen Deprivation, Docetaxel-based chemotherapy
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 JNJ-212082

    Type=exact number, unit=mg, number=250, form=tablet, route=oral. Patients will receive 4 tablets of abiraterone acetate at least 1 hour before a meal or 2 hours after a meal any time up to 10 pm every day.

  • PrednisoloneDrug

    Type=exact number, unit=mg, number=5, form=tablet, route=oral. Patients will receive 1 tablet of prednisolone twice daily.

Study groups in NCT01685983
Study groupRoleWhat they receive
Abiraterone actetate and PrednisoloneExperimentalNot described
Receives: Drug: Abiraterone acetate; Drug: Prednisolone

What is being measured

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

  1. Percentage of Participants With Prostate-specific Antigen (PSA) Response

    The PSA response was evaluated according to Prostate-Specific Antigen Working Group (PSAWG) criterion, which is, greater than or equal to 50 percent decrease in PSA from Baseline during the study, which would be subsequently confirmed by a measurement that is at least 4 or more weeks after initial documentation of PSA response.

    Measured: Baseline, Month 4

Secondary outcomes (6)

  1. Overall Survival

    Overall survival is defined as the time interval from the date of the first dose to the date of death due to any reason.

    Measured: Up to 3 Years

  2. Time to PSA Progression

    Time to PSA progression was measured as the time interval from the date of the first dose to the date of PSA progression as defined in the protocol-specific PSAWG criteria. For participants who have achieved a greater than or equal to (>=) 50% decrease from the baseline PSA, assessment of time to disease progression is when the PSA has increased 50% above the nadir and at a minimum of 5 nanogram/mililiter (ng/mL). For participants without a PSA decrease of this magnitude or without a decrease, the time for progression is calculated at the time a 25% increase from baseline PSA has been achieved.

    Measured: Up to 28 Months

  3. Percentage of Participants With Objective Radiographic Response

    Percentage of participants with radiographic objective response is defined as the percentage of participants with complete response (CR) or partial response (PR) as best overall response based on reconciled radiographic disease assessment according to RECIST Version 1.0. The CR is disappearance of all lesions. The PR is at least 30 percent decrease in sum of the longest diameter of target lesions or persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits.

    Measured: Up to 3 Years

  4. Serum Testosterone

    Median serum testosterone concentration was reported at baseline and End-of-Treatment visit.

    Measured: Baseline and End-of-Treatment Visit (up to approximately 3 years)

  5. Dehydroepiandrosterone Sulfate (DHEA-S)

    Median DHEA-S concentration was reported at baseline and End-of-Treatment visit.

    Measured: Baseline and End-of-Treatment Visit (up to approximately 3 years)

  6. Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

    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 posted17 Sep 2012 (estimated)
  2. Study start30 Aug 2011
  3. Primary completion24 Jan 2013
  4. Study completion6 Mar 2018

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
82 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01685983
Sponsor's protocol ID
CR100009
Other IDs
212082PCR2007
Status last verified
Feb 2019
First submitted
12 Sep 2012
Last updated
15 Mar 2019
Data monitoring committee
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Abiraterone acetate and Prednisolone in people with Prostate Cancer, run by Janssen Research & Development, LLC at 8 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 6 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 15 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in South Korea, Taiwan. 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 23 May 2016). 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?

Percentage of Participants With Prostate-specific Antigen (PSA) Response (time frame: Baseline, Month 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 NCT01685983.

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 15 Mar 2019.

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