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NCT00638690 · CITED IN SOURCE DOCUMENTS

Abiraterone Acetate in Castration-Resistant Prostate Cancer Previously Treated With Docetaxel-Based Chemotherapy

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE3
Status at capture
COMPLETED
Registry last update
2014-04-30

This is a phase 3 study to compare the clinical benefit of abiraterone acetate plus prednisone with placebo plus prednisone in patients with metastatic castration-resistant prostate cancer (CRPC) who have failed one or two chemotherapy regimens. At least one of the previous chemotherapies must have contained docetaxel.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Overall Survival

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outcome · POSTED

Time to Prostate-Specific Antigen Progression According to Prostate Specific Antigen Working Group Criteria

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outcome · POSTED

Number of Patients Achieving a Prostate-Specific Antigen Decline >=50%

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outcome · POSTED

Radiographic Progression-free Survival

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
Inclusion Criteria: * Metastatic Castration-Resistant Prostate Cancer Progression after one or two prior cytotoxic chemotherapies * At least one chemotherapy must have contained docetaxel * Eastern Cooperative Oncology Group (ECOG) Performance Status \<= 2 * Medical or surgical castration with testosterone \< 50 ng/dL * Adequate bone marrow, hepatic and renal function * Potassium \>= 3.5 mmol/L * Able to swallow the study drug whole as a tablet * Informed Consent Exclusion Criteria: * More than two prior cytotoxic chemotherapy regimens * Prior Ketoconazole for prostate cancer * Prior abiraterone acetate or other CYP17 inhibitor or investigational agents targeting the androgen receptor for prostate cancer * Uncontrolled hypertension * Active or symptomatic viral hepatitis or chronic liver disease * History of pituitary or adrenal dysfunction * Clinically significant heart disease * Other malignancy * Known brain metastasis * GI disorder affecting absorption * Not willing to use contraception
healthy Volunteers
false
minimum Age
18 Years
sex
MALE
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. intervention Names
    1. Drug: Abiraterone acetate
    2. Drug: Prednisone/prednisolone
    label
    Abiraterone acetate plus prednisone/prednisolone
    type
    EXPERIMENTAL
  2. intervention Names
    1. Drug: Placebo
    2. Drug: Prednisone/prednisolone
    label
    Placebo plus prednisone/prednisolone
    type
    PLACEBO_COMPARATOR
interventions
  1. arm Group Labels
    1. Placebo plus prednisone/prednisolone
    description
    Four tablets once daily until disease progression
    name
    Placebo
    type
    DRUG
  2. arm Group Labels
    1. Abiraterone acetate plus prednisone/prednisolone
    description
    Four 250-mg tablets once daily until disease progression
    name
    Abiraterone acetate
    type
    DRUG
  3. arm Group Labels
    1. Abiraterone acetate plus prednisone/prednisolone
    2. Placebo plus prednisone/prednisolone
    description
    5 mg twice daily until disease progression
    name
    Prednisone/prednisolone
    type
    DRUG
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
QUADRUPLE
who Masked
  1. PARTICIPANT
  2. CARE_PROVIDER
  3. INVESTIGATOR
  4. OUTCOMES_ASSESSOR
primary Purpose
TREATMENT
Enrollment
count
1195
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Overall survival is defined as the time interval from the date of randomization to the date of death from any cause.
    measure
    Overall Survival
    time Frame
    Up to 60 months
secondary Outcomes
  1. description
    The time interval from the date of randomization to the date of the prostate-specific antigen (PSA) progression as defined in the protocol-specific Prostate Specific Antigen Working Group (PSAWG) criteria, namely, a PSA level of at least 5 ng/ml that has risen on at least 2 successive occasions, at least 2 weeks apart.
    measure
    Time to Prostate-Specific Antigen Progression According to Prostate Specific Antigen Working Group Criteria
    time Frame
    Up to 12 months
  2. description
    A prostate-specific antigen (PSA) response was defined as a \>=50% decline from baseline.
    measure
    Number of Patients Achieving a Prostate-Specific Antigen Decline >=50%
    time Frame
    Up to 12 months
  3. description
    Radiographic progression-free survival is based on imaging studies according to modified Response Evaluation Criteria in Solid Tumors (RECIST): baseline lymph node size must be \>=2.0 cm to be considered a target lesion; progression on bone scans with \>=2 new lesions not consistent with tumor flare, confirmed on a second scan \>=6 weeks later that shows \>=1 additional new lesion.
    measure
    Radiographic Progression-free Survival
    time Frame
    Up to 11 months
Full study description
brief Summary
This is a phase 3 study to compare the clinical benefit of abiraterone acetate plus prednisone with placebo plus prednisone in patients with metastatic castration-resistant prostate cancer (CRPC) who have failed one or two chemotherapy regimens. At least one of the previous chemotherapies must have contained docetaxel.
detailed Description
Abiraterone acetate is a steroidal irreversible inhibitor of CYP17 (17α hydroxylase/C17, 20-lyase), blocking 2 important enzymatic activities in the synthesis of testosterone. The goal of this study is to compare the clinical benefit of abiraterone acetate plus prednisone with placebo plus prednisone in patients with metastatic castration-resistant prostate cancer (CRPC) who have failed one or two chemotherapy regimens, one of which contains docetaxel. All patients involved in the study will be randomized (assigned by chance) into one of two arms and will not know what study drug is being given to them. Study drug randomization allocation will be 2:1 (abiraterone acetate: placebo). The study will be conducted in the United States, Canada, Australia, and the EU. The study will consist of screening, treatment, and follow-up. In this study, patients will receive study treatment (abiraterone acetate or placebo) plus prednisone until progression of clinical disease. Follow-up will continue until patient dies, is lost to follow-up, or withdraws informed consent. After providing written informed consent, patients will have screening procedures completed to determine eligibility. Safety evaluations at the screening procedure will include a physical examination, vital signs, and clinical blood laboratory tests, ECG, radiographs, urine tests, and recording of any adverse events including details of current prostate cancer symptoms. Patients will be asked to use a method of birth control with adequate barrier protection as determined to be acceptable by the principal investigator and sponsor during the study and for 13 weeks after last study drug administration. Study medication, abiraterone acetate,is an oral (by mouth) medication to be administered as four (4) 250mg abiraterone acetate tablets or 4 placebo tablets to be taken at least one hour before or two hours after a meal anytime up to 10PM everyday. Prednisone will be administered as 5mg orally twice a day for both groups. Each cycle will be 28 days. Study treatment will continue until disease progression as determined by investigator or when the patient meets criteria for withdrawal from study.
Source references
references
  1. citation
    Zhao J, Cai X, Mo Z, Zhao D, Wang J, Yang Z, Long X, Li Y, Chen D, Li J, Zhou Z, Li S, Li Y. Association between concomitant ACEI/ARBs use and survival of patients with prostate cancer receiving abiraterone acetate: A post-hoc analysis of two randomized trials. Prostate Cancer Prostatic Dis. 2026 Jun 12. doi: 10.1038/s41391-026-01128-1. Online ahead of print.
    pmid
    42286315
    type
    DERIVED
  2. citation
    Heller G, McCormack R, Kheoh T, Molina A, Smith MR, Dreicer R, Saad F, de Wit R, Aftab DT, Hirmand M, Limon A, Fizazi K, Fleisher M, de Bono JS, Scher HI. Circulating Tumor Cell Number as a Response Measure of Prolonged Survival for Metastatic Castration-Resistant Prostate Cancer: A Comparison With Prostate-Specific Antigen Across Five Randomized Phase III Clinical Trials. J Clin Oncol. 2018 Feb 20;36(6):572-580. doi: 10.1200/JCO.2017.75.2998. Epub 2017 Dec 22.
    pmid
    29272162
    type
    DERIVED
  3. citation
    Chi KN, Kheoh T, Ryan CJ, Molina A, Bellmunt J, Vogelzang NJ, Rathkopf DE, Fizazi K, Kantoff PW, Li J, Azad AA, Eigl BJ, Heng DY, Joshua AM, de Bono JS, Scher HI. A prognostic index model for predicting overall survival in patients with metastatic castration-resistant prostate cancer treated with abiraterone acetate after docetaxel. Ann Oncol. 2016 Mar;27(3):454-60. doi: 10.1093/annonc/mdv594. Epub 2015 Dec 18.
    pmid
    26685010
    type
    DERIVED
  4. citation
    Fizazi K, Flaig TW, Stockle M, Scher HI, de Bono JS, Rathkopf DE, Ryan CJ, Kheoh T, Li J, Todd MB, Griffin TW, Molina A, Ohlmann CH. Does Gleason score at initial diagnosis predict efficacy of abiraterone acetate therapy in patients with metastatic castration-resistant prostate cancer? An analysis of abiraterone acetate phase III trials. Ann Oncol. 2016 Apr;27(4):699-705. doi: 10.1093/annonc/mdv545. Epub 2015 Nov 25.
    pmid
    26609008
    type
    DERIVED
  5. citation
    Antoun S, Bayar A, Ileana E, Laplanche A, Fizazi K, di Palma M, Escudier B, Albiges L, Massard C, Loriot Y. High subcutaneous adipose tissue predicts the prognosis in metastatic castration-resistant prostate cancer patients in post chemotherapy setting. Eur J Cancer. 2015 Nov;51(17):2570-7. doi: 10.1016/j.ejca.2015.07.042. Epub 2015 Aug 13.
    pmid
    26278649
    type
    DERIVED
  6. citation
    Xu XS, Ryan CJ, Stuyckens K, Smith MR, Saad F, Griffin TW, Park YC, Yu MK, Vermeulen A, Poggesi I, Nandy P. Correlation between Prostate-Specific Antigen Kinetics and Overall Survival in Abiraterone Acetate-Treated Castration-Resistant Prostate Cancer Patients. Clin Cancer Res. 2015 Jul 15;21(14):3170-7. doi: 10.1158/1078-0432.CCR-14-1549. Epub 2015 Mar 31.
    pmid
    25829400
    type
    DERIVED
  7. citation
    Scher HI, Heller G, Molina A, Attard G, Danila DC, Jia X, Peng W, Sandhu SK, Olmos D, Riisnaes R, McCormack R, Burzykowski T, Kheoh T, Fleisher M, Buyse M, de Bono JS. Circulating tumor cell biomarker panel as an individual-level surrogate for survival in metastatic castration-resistant prostate cancer. J Clin Oncol. 2015 Apr 20;33(12):1348-55. doi: 10.1200/JCO.2014.55.3487. Epub 2015 Mar 23.
    pmid
    25800753
    type
    DERIVED
  8. citation
    Mulders PF, Molina A, Marberger M, Saad F, Higano CS, Chi KN, Li J, Kheoh T, Haqq CM, Fizazi K. Efficacy and safety of abiraterone acetate in an elderly patient subgroup (aged 75 and older) with metastatic castration-resistant prostate cancer after docetaxel-based chemotherapy. Eur Urol. 2014 May;65(5):875-83. doi: 10.1016/j.eururo.2013.09.005. Epub 2013 Sep 20.
    pmid
    24099659
    type
    DERIVED
  9. citation
    Harland S, Staffurth J, Molina A, Hao Y, Gagnon DD, Sternberg CN, Cella D, Fizazi K, Logothetis CJ, Kheoh T, Haqq CM, de Bono JS, Scher HI; COU-AA-301 Investigators. Effect of abiraterone acetate treatment on the quality of life of patients with metastatic castration-resistant prostate cancer after failure of docetaxel chemotherapy. Eur J Cancer. 2013 Nov;49(17):3648-57. doi: 10.1016/j.ejca.2013.07.144. Epub 2013 Aug 22.
    pmid
    23973186
    type
    DERIVED
  10. citation
    Ryan CJ, Molina A, Li J, Kheoh T, Small EJ, Haqq CM, Grant RP, de Bono JS, Scher HI. Serum androgens as prognostic biomarkers in castration-resistant prostate cancer: results from an analysis of a randomized phase III trial. J Clin Oncol. 2013 Aug 1;31(22):2791-8. doi: 10.1200/JCO.2012.45.4595. Epub 2013 Jul 1.
    pmid
    23816964
    type
    DERIVED
  11. citation
    Logothetis CJ, Basch E, Molina A, Fizazi K, North SA, Chi KN, Jones RJ, Goodman OB, Mainwaring PN, Sternberg CN, Efstathiou E, Gagnon DD, Rothman M, Hao Y, Liu CS, Kheoh TS, Haqq CM, Scher HI, de Bono JS. Effect of abiraterone acetate and prednisone compared with placebo and prednisone on pain control and skeletal-related events in patients with metastatic castration-resistant prostate cancer: exploratory analysis of data from the COU-AA-301 randomised trial. Lancet Oncol. 2012 Dec;13(12):1210-7. doi: 10.1016/S1470-2045(12)70473-4. Epub 2012 Nov 9.
    pmid
    23142059
    type
    DERIVED
  12. citation
    Fizazi K, Scher HI, Molina A, Logothetis CJ, Chi KN, Jones RJ, Staffurth JN, North S, Vogelzang NJ, Saad F, Mainwaring P, Harland S, Goodman OB Jr, Sternberg CN, Li JH, Kheoh T, Haqq CM, de Bono JS; COU-AA-301 Investigators. Abiraterone acetate for treatment of metastatic castration-resistant prostate cancer: final overall survival analysis of the COU-AA-301 randomised, double-blind, placebo-controlled phase 3 study. Lancet Oncol. 2012 Oct;13(10):983-92. doi: 10.1016/S1470-2045(12)70379-0. Epub 2012 Sep 18.
    pmid
    22995653
    type
    DERIVED
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    Preserved source evidence · Not medical advice