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Metastatic Castration-Resistant Prostate CancerPhase 4NCT02405858

A Study of Abiraterone Acetate in Metastatic Castration-Resistant Prostate Cancer Participants Who Responded Poorly to the First-line Combined Androgen Blockade Therapy

A Phase 4 study testing Abiraterone Acetate and Prednisolone in people with Metastatic Castration-Resistant Prostate Cancer, run by Janssen Pharmaceutical K.K. at 14 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 evaluate the percentage of participants achieving prostate-specific antigen (PSA) response by 12 weeks of therapy from baseline according to Prostate Cancer Clinical Trials Working Group (PCWG2) criteria. Read more about this study

Who is it for?
Ages 20 years and older, men only
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
51 participants
Where
14 sitesJapan
Study dates
10 Apr 2015to 31 Dec 2017
Phase
Phase 4
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

  • Participants who have histologically or cytologically confirm adenocarcinoma of the prostate without neuroendocrine differentiation or small cell histology
  • Participants who had prostate-specific antigen (PSA) progression defined as a rise of PSA at least 1 week apart resulting in 25 percent (%) increase in PSA with last PSA greater than (>) 2 nanogram per milliliter (ng/mL) (according to PCWG2) after antiandrogen withdrawal
  • Participants who had PSA progression within a year after the start of first-line CAB therapy, or who had PSA progression without having a normal PSA level (less than [<] 4.0 ng/mL) in the first-line combined androgen blockade (CAB) therapy
  • Participants who have not been treated with cytotoxic chemotherapy (including estramustine) for the treatment of prostate cancer (neoadjuvant or adjuvant chemotherapy is only allowed if the last dose is greater than or equal to [>=] 1 year from the scheduled date of initial administration of abiraterone acetate)
  • Participants who have target or non-target metastatic abnormalities either on screening bone scan, computed tomography (CT) or magnetic resonance imaging (MRI)

Who cannot join

  • A participant who has known allergies, hypersensitivity, or intolerance to abiraterone acetate or its excipients
  • A participant who has severe liver dysfunction (Child-Pugh Score C), active or symptomatic viral hepatitis or chronic liver disease
  • A participant who has received other hormonal therapy, including any dose of finasteride, dutasteride, any herbal product known to decrease PSA levels (example: Saw Palmetto and PC-SPES) within 4 weeks prior to the scheduled date of initial administration of abiraterone acetate
  • A participant who has had surgery or local prostatic intervention within 4 weeks prior to the scheduled date of initial administration of abiraterone acetate
  • A participant who has active infection or other medical condition that would make prednisolone use contraindicated

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

Japan14 sites

  • Study site

    Asahi

  • Study site

    Higashi-Ibaraki

  • Study site

    Kanazawa

  • Study site

    Kobe

  • Study site

    Koshigaya

  • Study site

    Kumamoto

  • Study site

    Narashino

  • Study site

    Okayama

  • Study site

    Sagamihara

  • Study site

    Sakura

  • Study site

    Shinjuku-Ku

  • Study site

    Sunto

  • Study site

    Yokohama

  • Study site

    Yokosuka

Other trials in Japan

About this study

Official title: A Phase 4 Study of Zytiga in Poor-risk mCRPC (Metastatic Castration-Resistant Prostate Cancer) Patients Who Was Failed the First-line CAB (Combined Androgen Blockade) Therapy

The purpose of this study is to evaluate the percentage of participants achieving prostate-specific antigen (PSA) response by 12 weeks of therapy from baseline according to Prostate Cancer Clinical Trials Working Group (PCWG2) criteria.

Read the detailed description

This is a Phase 4, non-randomized, multi-center (when more than one hospital work on a medical research study), open label (identity of study drug will be known to participant and study staff), single arm study of abiraterone acetate to investigate its efficacy and safety in participants with metastatic castration-resistant prostate cancer (mCRPC) who failed the first-line combined androgen blockade (CAB) therapy. The study consists of Screening Phase (28 days prior to Cycle 1 Day 1), Treatment Phase (up to 2 years), Post Treatment Phase (30 days after the last dose of study drug). Participants will receive 1000 milligram (mg) (four 250 mg tablets) of abiraterone acetate orally once daily. In addition, 5 mg of oral prednisolone will be concomitantly administered twice a day (10 mg per day). A 28-daily dosing cycle will be continued until disease progression or unacceptable toxicity is observed. The total duration of study will be 2 years. Participants will be primarily evaluated for PSA response. Participants' safety will be monitored throughout the study.

Being tested
Abiraterone Acetate, Prednisolone
Keywords
Metastatic Castration-Resistant Prostate Cancer, Abiraterone Acetate, ZYTIGA, Prednisolone

What participants receive

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

  • Abiraterone AcetateDrug

    Also called ZYTIGA

    Abiraterone acetate 1000 milligram (mg) (four 250 mg tablets) orally once daily up to Cycle 26.

  • PrednisoloneDrug

    Oral prednisolone 5 mg will be concomitantly administered twice a day (10 mg/day) up to Cycle 26.

Study groups in NCT02405858
Study groupRoleWhat they receive
Abiraterone AcetateExperimentalParticipants will receive abiraterone acetate 1000 milligram (mg) (four 250 mg tablets) orally once daily, concomitantly with oral prednisolone 10 mg per day. No food should be consumed for at least 2 hours before the dose of abiraterone acetate is taken and for at least one hour after the dose of abiraterone acetate is taken. A 28-daily dosing cycle will continue until disease progression or unacceptable toxicity is observed up to 2 years.
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 Achieving Prostate-specific Antigen (PSA) Response (PSA Response Rate) by 12 Weeks of Therapy

    A PSA response is defined as the first occurrence of greater than or equal to (>=) 50 percent (%) decrease from baseline by 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 the initial documentation.

    Measured: up to 2 years

Secondary outcomes (11)

  1. Duration of PSA Response

    Duration of PSA response was defined as the duration between the date of confirmed PSA response and subsequent PSA progression date.

    Measured: Up to 2 years

  2. Time to PSA Response

    Time to PSA response is the time from start of treatment to PSA progression.

    Measured: Up to 2 years

  3. Percentage of Participants Achieving PSA Response by 24 weeks of Therapy

    A PSA response is defined as the first occurrence of greater than or equal to (>=) 50 percent (%) decrease from baseline by 24 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 the initial documentation.

    Measured: Up to 2 years

  4. PSA-based Progression-free Survival (PSA-PFS)

    PSA-based Progression-free Survival is the time from randomization to the occurrence of one of the following: radiographic progression, clinical progression or death.

    Measured: Time from randomization up to radiographic progression, clinical progression or death, whichever occurs first (maximum up to 2 years)

  5. Maximum Serum PSA Decline Evaluation

    Maximum PSA Decline will be calculated as Baseline PSA level minus lowest PSA level, observed during the 2 year monthly planned PSA lab test and lowest PSA data will be used for calculating the maximum serum PSA decline.

    Measured: Baseline and Day 1 of each cycle up to 2 years

  6. Percentage of Participants With Radiographic Objective Response Rate (RAD-ORR) in Participants with Measurable Lesions at Baseline

    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 1.1.

    Measured: Baseline, Day 1 of Cycle 1, 2,3 and 4 until first documented disease progression or up to 2 years

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

    RAD-PFS is defined as the time from enrollment to the occurrence of radiographic progression or death.

    Measured: Time from enrollment up to radiographic progression or death, whichever occurs first (up to 2 years)

  8. Time to Next Treatment

    Time to next treatment was calculated as the number of days from either discontinuation of the study drug or the administration of the last dose, until the participants needed next treatment.

    Measured: up to 2 years

  9. Overall Survival

    Overall survival is defined as the time from enrollment to date of death due to any cause.

    Measured: Time from enrollment to date of death due to any cause (up to 2 years)

  10. Brief Pain Inventory - Short Form

    Pain will be evaluated using the BPI-SF instrument. Total score is an average of the pain interference score (mean value for the 9 BPI-SF questions [questions inquiring about the extent of interference with activities by pain, where the extent is ranked from 0 (does not interfere) to 10 (completely interferes)]) and pain subscale score (mean value for the scores for BPI-SF questions 3, 4, 5 and 6 [questions inquiring about the extent of pain, where the extent is ranked from 0 (no pain) to 10 (pain as bad as you can imagine)]). Total score ranges from 0 to 10 with higher values indicating more pain.

    Measured: Baseline, Day 1 of Cycle 1, 2,3 and 4 up to 2 years

  11. Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)

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

    Measured: up to 2 years

Timeline

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

  1. First posted1 Apr 2015 (estimated)
  2. Study start10 Apr 2015
  3. Primary completion31 Dec 2017
  4. Study completion31 Dec 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 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
51 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02405858
Sponsor's protocol ID
CR106841
Other IDs
ABI-C-14-JP-001-V03
Status last verified
Jan 2025
First submitted
27 Mar 2015
Last updated
3 Feb 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Abiraterone Acetate and Prednisolone in people with Metastatic Castration-Resistant Prostate Cancer, run by Janssen Pharmaceutical K.K. at 14 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 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 (PSA Response Rate) by 12 Weeks of Therapy (time frame: up to 2 years). 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 NCT02405858.

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 3 Feb 2025.

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