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Prostate CancerPhase 2NCT01756638

A Phase 2 Study to Evaluate Safety and Efficacy of Abiraterone in Participants With Prostate Cancer

A Phase 2 study testing Abiraterone and Prednisolone in people with Prostate Cancer, run by Janssen Research & Development, LLC at 19 sites in Japan.

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 investigate safety and efficacy of abiraterone in participants with metastatic castration-resistant prostate cancer (mCRPC) and who have not received prior chemotherapy (treatment of disease, usually cancer, by chemical agents). Read more about this study

Who is it for?
Ages 20 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Abiraterone and Prednisolone
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
19 sitesJapan
Study dates
6 Jun 2012to 17 Oct 2014
Phase
Phase 2
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 20 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • In-patients or out-patients with histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell histology
  • Have surgically or medically castrated, with testosterone levels of less than 50 nanogram per deciliter
  • Have prostate-specific antigen (PSA) level of at least 5 nanogram per milliliter
  • Be under PSA progression according to Prostate-Specific Antigen Working Group (PSAWG) eligibility criteria or objective progression by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 criteria for participants with measurable disease after androgen deprivation
  • Have Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1

Who cannot join

  • Has received other hormonal therapy, including any dose of finasteride, dutasteride, any herbal product known to decrease PSA levels or any systemic corticosteroid within 4 weeks prior to Cycle 1 Day 1 or has received ketoconazole for prostate cancer
  • Has received radiotherapy, chemotherapy (including estramustine) or immunotherapy (including provenge) within 4 weeks, or single fraction of palliative radiotherapy within 2 weeks prior to Cycle 1 Day 1
  • Has had surgery or local prostatic intervention within 4 weeks prior to Cycle 1 Day 1. In addition, any clinically relevant sequel from the surgery must have resolved prior to Cycle 1 Day 1
  • Has clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events, severe or unstable angina, or New York Heart Association (NYHA) Class 3 to 4 heart disease or cardiac ejection fraction measurement of less than 50 percent within 6 months prior to Cycle 1 Day 1
  • Has uncontrolled hypertension (systolic blood pressure greater than or equal to 160 millimeter of mercury or diastolic blood pressure greater than or equal to 95 millimeter of mercury)

Trial locations and contacts

19 sites in 1 country.

19 sites in 1 country

Japan19 sites

  • Study site

    Asahi

  • Study site

    Fukuoka

  • Study site

    Gifu

  • Study site

    Kanazawa

  • Study site

    Kashiwa

  • Study site

    Kita-Gun

  • Study site

    Kukichūō

  • Study site

    Kurashiki

  • Study site

    Maebashi

  • Study site

    Matsuyama

  • Study site

    Mitaka

  • Study site

    Niigata

  • Study site

    Osaka

  • Study site

    Ōsaka-sayama

  • Study site

    Sagamihara

  • Study site

    Sakura

  • Study site

    Sapporo

  • Study site

    Yokohama

  • Study site

    Yokosuka

Other trials in Japan

About this study

Official title: A Phase II Study of JNJ-212082 (Abiraterone Acetate) in Metastatic Castration Resistant Prostate Cancer Patients Who Are Chemotherapy-Naïve

The purpose of this study is to investigate safety and efficacy of abiraterone in participants with metastatic castration-resistant prostate cancer (mCRPC) and who have not received prior chemotherapy (treatment of disease, usually cancer, by chemical agents).

Read the detailed description

This is a multi-center (conducted in more than one center), open-label (all people know the identity of the intervention), single-arm study to investigate safety and efficacy of abiraterone. The study consists of 3 phases: Screening phase (consists of 14 days before study commences on Day -1); Treatment phase (consists of 28-daily dosing cycles wherein abiraterone 1000 milligram [mg] once daily along with 5 mg prednisolone twice daily will be given until disease progression or unacceptable toxicity is observed); and Follow-up phase (up to 5 years or until survival after the first dose of study drug). Abiraterone will be orally administered daily as at least 1 hour before the meal or 2 hours after the meal. Dose reduction will be allowed at the Investigator's discretion but not lower than 500 mg per day. Participants will discontinue study treatment at disease progression unless, in the Investigator's opinion, it is deemed that the participants will continue to derive benefit from abiraterone. Efficacy will be evaluated primarily through decline in prostate-specific antigen (substance in blood that is measured to check for prostate cancer) after 12 weeks of therapy. Participants' safety will be monitored throughout the study.

Conditions
Prostate Cancer
Being tested
Abiraterone, Prednisolone
Keywords
Prostate cancer, Abiraterone acetate, JNJ-212082
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • AbirateroneDrug

    Also called JNJ-212082

    Abiraterone will be administered orally as 1000 milligram (mg) per day for 28-daily dosing cycles which will be continued until disease progression or unacceptable toxicity.

  • PrednisoloneDrug

    Prednisolone will be administered orally as 5 mg tablets twice daily for 28-daily dosing cycle which will be continued until disease progression or unacceptable toxicity.

Study groups in NCT01756638
Study groupRoleWhat they receive
Abiraterone plus PrednisoloneExperimentalAbiraterone 1000 milligram (mg) oral tablets will be administered once daily along with 5 mg oral prednisolone tablet administered twice daily for 28-daily dosing cycles and will be continued until disease progression or unacceptable toxicity.
Receives: Drug: Abiraterone; Drug: Prednisolone

What is being measured

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

  1. Percentage of participants achieving Prostate-Specific Antigen (PSA) response up to 12 weeks

    The PSA response will be evaluated according to Prostate-Specific Antigen Working Group (PSAWG) criterion, which is, greater than or equal to 50 percent decrease in PSA from Baseline up to 12 weeks after the first dose of study drug, which would be subsequently confirmed by a measurement that is at least 4 or more weeks after initial documentation of PSA.

    Measured: Baseline up to 12 weeks

Secondary outcomes (10)

  1. Percentage of participants with Radiographic Objective 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 Response Evaluation Criteria in Solid Tumors (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: Baseline, Day 1 of Cycle 4, 7 and 10, and thereafter every third cycle until first documented disease progression or up to 5 years

  2. Duration of Prostate-Specific Antigen (PSA) response

    Duration of a PSA response is the time taken to achieve a PSA response that is decrease in PSA from Baseline by greater than or equal to 50 percent.

    Measured: Baseline and Day 1 of each cycle up to 5 years

  3. Percentage of participants achieving Prostate-Specific Antigen (PSA) response

    The PSA response is decrease in PSA from Baseline by greater than or equal to 50 percent.

    Measured: Baseline and Day 1 of each cycle up to 5 years

  4. Clinical benefit

    Clinical Benefit is defined as a confirmed complete response (CR), confirmed partial response (PR), or stable disease (SD) 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. The SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease since treatment started.

    Measured: Baseline, Day 1 of Cycle 4, 7 and 10, and thereafter every third cycle up to 5 years

  5. Eastern Cooperative Oncology Group Performance Status (ECOG PS) score

    The ECOG PS Score 0 versus 1, wherein 0 signifies fully active, able to carry all pre-disease performance without restriction and 1 signifies restriction in physically strenuous activity but ambulatory and able to carry out work on a light or sedentary nature, for example, light housework, office work.

    Measured: Baseline, Day 1, 8, 15 and 22 of Cycle 1 and 2, and thereafter Day 1 and 15 of all cycles up to 5 years

  6. Decline in Serum Prostate-Specific Antigen (PSA)

    Decline in serum PSA according to Prostate Cancer Clinical Trials Working Group 2 (PCWG2) criterion, which is, 25 percent increase in PSA and an absolute increase in PSA level by 2 nanogram per milliliter or more, from Baseline which would be subsequently confirmed by a measurement that is at least 4 or more weeks after initial documentation of PSA.

    Measured: Baseline and Day 1 of each cycle up to 5 years

  7. Overall survival

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

    Measured: Every 3 months until death or up to 5 years

  8. Prostate-Specific Antigen based Progression-free Survival (PSA-PFS)

    The PSA-PFS is defined as time to first PSA failure (that is, two consecutive increases in PSA of 50 percent and greater than or equal to 5 nanogram per milliliter, as per Prostate-Specific Antigen Working Group [PSAWG]criterion) or death .

    Measured: Baseline and Day 1 of each cycle until first documented disease progression or up to 5 years

  9. Radiographic Progression-free Survival (RAD-PFS)

    The RAD-PFS is defined as time from randomization to the earliest objective evidence of radiographic progression or death due to any cause. The RAD-PFS will be evaluated according to RECIST Version 1.0.

    Measured: Baseline, Day 1 of Cycle 4, 7 and 10, and thereafter every third cycle until first documented disease progression or up to 5 years

  10. Percentage of participants with Circulating Tumor Cell (CTC) conversion

    The CTC is the pharmacodynamic potential predictive biomarker for tumor sensitivity.

    Measured: Day 1 of Cycle 2, 3, and 4

Timeline

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

  1. First posted27 Dec 2012 (estimated)
  2. Study start6 Jun 2012
  3. Primary completion17 Oct 2014
  4. Study completion17 Oct 2014

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
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01756638
Sponsor's protocol ID
CR017059
Other IDs
JNJ-212082-JPN-201
Status last verified
Oct 2017
First submitted
20 Dec 2012
Last updated
23 Oct 2017
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No

Publications

  • Matsubara N, Uemura H, Satoh T, Suzuki H, Nishiyama T, Uemura H, Hashine K, Imanaka K, Ozono S, Akaza H. A phase 2 trial of abiraterone acetate in Japanese men with metastatic castration-resistant prostate cancer and without prior chemotherapy (JPN-201 study). Jpn J Clin Oncol. 2014 Dec;44(12):1216-26. doi: 10.1093/jjco/hyu149. Epub 2014 Oct 15.

    PubMed 25320340

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Abiraterone and Prednisolone in people with Prostate Cancer, run by Janssen Research & Development, LLC at 19 sites in Japan.

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 5 inclusion and 5 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 23 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in Japan. 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?

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?

Percentage of participants achieving Prostate-Specific Antigen (PSA) response up to 12 weeks (time frame: Baseline up 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 NCT01756638, 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 23 Oct 2017.

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Clinical Trial NCT01756638 | AzTrials