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Prostatic NeoplasmsPhase 2NCT00485303

An Efficacy and Safety Study of Abiraterone Acetate and Prednisone in Participants With Prostate Cancer Who Failed Androgen Deprivation and Docetaxel-Based Chemotherapy

A Phase 2 study testing Abiraterone acetate and Prednisone in people with Prostatic Neoplasms and Prostate Cancer, run by Cougar Biotechnology, Inc. at 14 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 evaluate the efficacy and safety of abiraterone acetate in participants with advanced prostate cancer (a disease in which cells in the prostate gland become abnormal and start to grow uncontrollably, forming tumors). Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostatic Neoplasms, Prostate Cancer
What is being tested?
Abiraterone acetate and Prednisone
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
58 participants
Where
14 sitesin 2 countries
Study dates
Jun 2007to Oct 2011
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 (malignant epithelial tumor with a glandular organization)of the prostate (a gland in the male reproductive system found below the bladder and in front of the rectum), but not with neuroendocrine (specialized neurons that produce hormones, such as neuropeptides or biogenic amines) differentiation or of small cell histology
  • Prior chemotherapy (treatment of disease, usually cancer, by chemical agents) for prostate cancer with regimen(s) containing docetaxel
  • Documented prostate specific antigen (PSA) progression according to Prostate Specific Antigen Working Group (PSAWG) eligibility criteria with a PSA more than (>) 5 nanogram per milliliter (ng/mL) or objective progression by Response Evaluation Criteria in Solid Tumors (RESIST) criteria
  • Ongoing androgen deprivation with serum testosterone less than (<) 50 nanogram per deciliter (ng/dL)
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of less than equal to (<=) 2 (Karnofsky Performance Status >= 50 percent)

Who cannot join

  • Active or uncontrolled autoimmune disease (disorder in which a person's immune system attacks parts of his or her own body) that may require corticosteroid therapy
  • Serious or uncontrolled co-existent non-malignant disease, including active and uncontrolled infection
  • Uncontrolled hypertension (high blood pressure)
  • Hemoglobin <=9.0 gram per deciliter (g/dL) without growth factor or transfusion support
  • Abnormal liver (large organ that helps in many body functions, including digestion, metabolism, and storage of substances) function

Trial locations and contacts

14 sites in 2 countries.

14 sites in 2 countries

United States12 sites

  • John Hopkins

    Baltimore, Maryland, 21205

  • Study site

    Baltimore, Maryland

  • Masachussetts General Hospital Cancer Center

    Boston, Massachusetts, 02114

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02115

  • Beth Israel Hospital

    Boston, Massachusetts, 02215

  • Study site

    Boston, Massachusetts

  • UCLA

    Los Angeles, California, 90024

  • Study site

    Los Angeles, California

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10021

  • Study site

    New York, New York

  • UCSF Comprehensive Cancer Center

    San Francisco, California, 94115

  • Study site

    San Francisco, California

Other trials in United States

United Kingdom2 sites

  • Royal Marsden Hospital

    Sutton

  • Study site

    Sutton

Other trials in United Kingdom

About this study

Official title: A Phase II Open Label Study of CB7630 (Abiraterone Acetate) and Prednisone in Patients With Advanced Prostate Cancer Who Have Failed Androgen Deprivation and Docetaxel-Based Chemotherapy

The purpose of this study is to evaluate the efficacy and safety of abiraterone acetate in participants with advanced prostate cancer (a disease in which cells in the prostate gland become abnormal and start to grow uncontrollably, forming tumors).

Read the detailed description

This is an open-label (all people know the identity of the intervention), single-arm, multicenter (when more than one hospital or medical school team work on a medical research study) study to evaluate the anti-tumor activities and safety of abiraterone acetate in participants with prostate cancer who have failed androgen deprivation and docetaxel-based chemotherapy. Abiraterone acetate oral tablet will be administered as a total dose of 1000 milligram (mg) orally (by mouth) once daily after an overnight fast and prednisone/prednisolone will be administered as 5 mg oral tablet twice daily. Participants will be enrolled and treated up to 12 cycles (or longer, if they have not progressed and continue to benefit from treatment). The study will consist of 3 parts: Screening (14 days), Open-label Treatment; and follow-up (up to 60 months). Participants will be evaluated primarily for prostate specific antigen response according to Prostate Specific Antigen Working Group (PSAWG) criteria. Participants' safety will be monitored throughout the study.

Being tested
Abiraterone acetate, Prednisone
Keywords
Prostatic Neoplasms, Prostate cancer, Abiraterone acetate, CB7630, Prednisone
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

    Abiraterone acetate oral tablets 250 milligram (mg) each will be administered at a total dose of 1000 mg until documented disease progression or unacceptable toxicity.

  • PrednisoneDrug

    Also called CB7630

    Prednisone/Prednisolone 5 mg tablet will be taken orally twice daily.

Study groups in NCT00485303
Study groupRoleWhat they receive
AbirateroneExperimentalAbiraterone acetate 1000 milligram (mg) (4 oral tablets of 250 mg each) will be administered once daily along with 5 mg oral prednisolone tablet administered twice daily for 28-days dosing cycle and will be continued until disease progression or unacceptable toxicity.
Receives: Drug: Abiraterone acetate; Drug: Prednisone

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: Day 1 of each cycle (of 28 days each) up to Cycle 12

Secondary outcomes (8)

  1. 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 or the start of secondary anti-tumor therapy, whichever occurs first. If a PSA progression or death does not occur, subject will be censored at the last PSA evaluation.

    Measured: Baseline and Day 1 of each cycle until first documented disease progression or up to 60 months

  2. Radiographic Progression Free Survival (PFS)

    The RAD-PFS is defined as the time from randomization to the earliest objective evidence of radiographic progression or death due to any cause. Progression is defined using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0, as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions.

    Measured: Baseline, Day 1 of Cycle 4, 7 and 10, and thereafter every third cycle until first documented disease progression or up to 60 months

  3. Overall Survival (OS)

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

    Measured: Every 3 months until death or up to 60 months

  4. 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: Baseline, Day 1 of Cycle 4, 7 and 10, and thereafter every third cycle until first documented disease progression or up to 60 months

  5. Time to PSA Progression

    The time interval from first dose of abiraterone acetate to the date of PSA progression as defined by the Prostate-Specific Antigen Working Group (PSAWG) criteria. If a PSA progression does not occur, subject will be censored at the last PSA evaluation.

    Measured: Day 8 of Cycle 1, thereafter Day 1 of each cycle up to end of study (60 months)

  6. Time to Radiographic Progression

    Time to radiographic progression is defined as the time from first dose until the first radiographic progression date that was confirmed.

    Measured: Baseline, Day 1 of Cycle 4, 7 and 10, and thereafter every third cycle until first documented disease progression or up to 60 months

  7. Shift From Baseline in Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Score

    ECOG performance status score ranges from 0 to 5 where 0=fully active, perform all pre-disease activities without restriction. 1=restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature, 2=ambulatory, capable of self-care, unable to carry out any work activities, up and about more than (>) 50 percent of waking hours, 3=capable of limited self-care, confined to bed or chair >50 percent of waking hours, 4=completely disabled, not capable of any self-care, totally confined to bed or chair and 5=dead.

    Measured: Baseline and Day 1 of each cycle until first documented disease progression or up to 60 months

  8. Percentage of Participants With Clinical Benefit

    Clinical benefit was defined as an observation of at least 1 of the following: PSA response by PSAWG criteria; radiographic response by RECIST criteria; stable disease by RECIST criteria lasting 6 months; or improvement by at least 1 unit in ECOG performance status.

    Measured: Baseline, Day 1 of Cycle 4, 7 and 10, and thereafter every third cycle until first documented disease progression or up to 60 months

Timeline

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

  1. First posted12 Jun 2007 (estimated)
  2. Study startJun 2007
  3. Primary completionOct 2011
  4. Study completionOct 2011

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
58 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00485303
Sponsor's protocol ID
CR016921
Other IDs
COU-AA-004, 2007-002725-74
Status last verified
Jun 2013
First submitted
8 Jun 2007
Last updated
2 Jul 2013
Data monitoring committee
No

Publications

  • Danila DC, Anand A, Sung CC, Heller G, Leversha MA, Cao L, Lilja H, Molina A, Sawyers CL, Fleisher M, Scher HI. TMPRSS2-ERG status in circulating tumor cells as a predictive biomarker of sensitivity in castration-resistant prostate cancer patients treated with abiraterone acetate. Eur Urol. 2011 Nov;60(5):897-904. doi: 10.1016/j.eururo.2011.07.011. Epub 2011 Jul 14.

    PubMed 21802835

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Abiraterone acetate and Prednisone in people with Prostatic Neoplasms and Prostate Cancer, run by Cougar Biotechnology, Inc. at 14 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 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 2 Jul 2013. 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 United States, United Kingdom. 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 17 Jun 2013). 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: Day 1 of each cycle (of 28 days each) up to Cycle 12). 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 NCT00485303, 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 2 Jul 2013.

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