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Abiraterone Acetate in Asymptomatic or Mildly Symptomatic Patients With Metastatic Castration-Resistant Prostate Cancer

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ClinicalTrials.gov Identifier: NCT00887198
Recruitment Status : Completed
First Posted : April 23, 2009
Results First Posted : April 9, 2015
Last Update Posted : June 25, 2018
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Tracking Information
First Submitted Date  ICMJE April 18, 2009
First Posted Date  ICMJE April 23, 2009
Results First Submitted Date March 30, 2015
Results First Posted Date April 9, 2015
Last Update Posted Date June 25, 2018
Actual Study Start Date  ICMJE April 28, 2009
Actual Primary Completion Date March 31, 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 30, 2015)
  • Overall Survival [ Time Frame: From randomization (Day 1) up to end of study (Month 60) ]
    Overall survival is defined as the time from randomization to date of death from any cause.
  • Radiographic Progression-free Survival (rPFS) [ Time Frame: From randomization (Day 1) up to first radiographic progression or cutoff date (Month 18) ]
    The rPFS was defined as the time from randomization to the occurrence of one of the following: 1) a participant was considered to have progressed by bone scan if - a) the first bone scan with greater than or equal to (>=) 2 new lesions compared to baseline was observed in less than (<) 12 weeks from randomization and was confirmed by a second bone scan taken >=6 weeks later showing >=2 additional new lesions (a total of >=4 new lesions compared to baseline), b) the first bone scan with >=2 new lesions compared to baseline was observed in >=12 weeks from randomization and the new lesions were verified on the next bone scan >=6 weeks later (a total of >=2 new lesions compared to baseline); 2) progression of soft tissue lesions measured by computerized tomography (CT) or magnetic resonance imaging (MRI); 3) death from any cause.
Original Primary Outcome Measures  ICMJE
 (submitted: April 22, 2009)
Overall Survival (OS) and Progression-Free Survival [ Time Frame: Every 3 months while on study and during follow up ]
Change History Complete list of historical versions of study NCT00887198 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 28, 2015)
  • Time to Opiate Use for Prostate Cancer Pain [ Time Frame: From randomization (Day 1) up to first opiate use or end of study (Month 60) ]
    The time interval from the date of randomization to the date of opiate use for cancer pain. Participants who have no opiate use at the time of analysis were censored at the last known date of no opiate use for cancer pain. Participants with no assessment were censored at the date of randomization.
  • Time to Initiation of Cytotoxic Chemotherapy [ Time Frame: From randomization (Day 1) up to initiation of cytotoxic chemotherapy or cutoff date (Month 18) ]
    The time interval from the date of randomization to the date of initiation of cytotoxic chemotherapy for prostate cancer. Participants who had no cytotoxic chemotherapy administration at the time of analysis were censored at the last known date when no cytotoxic chemotherapy was administered. Participants with no assessment were censored at the date of randomization.
  • Time to Deterioration in Eastern Cooperative Oncology Group (ECOG) Performance Score by >=1 Point [ Time Frame: From randomization (Day 1) up to first radiographic progression or cutoff date (Month 18) ]
    The time interval from the date of randomization to the first date at which there was at least a 1 grade change (worsening) in the ECOG performance status grade. Participants who had no deterioration in ECOG performance status grade at the time of the analysis were censored at the last known date of no deterioration. ECOG is a 5-point scale, where 0=Fully active, 1=Ambulatory, carry out work of sedentary nature, 2=Ambulatory, capable of all self-care, 3=Capable of limited self-care, confined to bed or chair more than 50% of waking hours, 4=Completely disabled, no self-care, totally confined to bed or chair, 5=Dead. Participants with no assessment were censored at the date of randomization.
  • Time to Prostate-specific Antigen (PSA) Progression [ Time Frame: From randomization (Day 1) up to date of PSA progerssion or cutoff date (Month 18) ]
    The time interval from the date of randomization to the date of PSA progression as defined in the protocol-specific prostate cancer Working Group 2 (PCWG2) criteria. A participant was considered to have a PSA progression if the PSA level had a 25 percent (%) or greater increase from nadir and an absolute increase of 2 nanogram/milliliter ((ng/mL) or more, which is confirmed by a second value obtained in 3 or more weeks. Participants who had no PSA progression at the time of the analysis were censored at the last known date of no PSA progression. Participants with no on-study PSA assessment or no baseline PSA assessment were censored at the date of randomization.
  • Number of Participants With Treatment Emergent Adverse Events [ Time Frame: From first dose of study drug up to 30 days after the last dose of study drug ]
    An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (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. Treatment-emergent were events between administration of study drug and up to 30 days after last dose of study drug that were absent before treatment or that worsened relative to pre-treatment state.
  • Mean Plasma Concentrations of Abiraterone [ Time Frame: Up to Cycle 5, Day 1 ]
  • Maximum Plasma Concentrations of Abiraterone [ Time Frame: Up to Cycle 5, Day 1 ]
  • Area Under the Plasma Concentration-time Curve From Time 0 to Time the Last Quantifiable Concentration of Abiraterone (AUC[0-infinity]) [ Time Frame: Up to Cycle 5, Day 1 ]
    The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z); wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.
  • Elimination Half-Life (t1/2) [ Time Frame: Up to Cycle 5, Day 1 ]
    The elimination half-life (t1/2) is the time measured for the plasma concentration to decrease by 1 half to its original concentration. It is associated with the terminal slope of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z).
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Abiraterone Acetate in Asymptomatic or Mildly Symptomatic Patients With Metastatic Castration-Resistant Prostate Cancer
Official Title  ICMJE A Phase 3, Randomized, Double-blind, Placebo-Controlled Study of Abiraterone Acetate (CB7630) Plus Prednisone in Asymptomatic or Mildly Symptomatic Patients With Metastatic Castration-Resistant Prostate Cancer
Brief Summary This is a phase 3 study to compare the clinical benefit of abiraterone acetate plus prednisone with placebo plus prednisone in asymptomatic or mildly symptomatic patients with metastatic castration-resistant prostate cancer (CRPC).
Detailed Description This is a randomized (individuals will be assigned by chance to study treatments), double-blind (individuals and study personnel will not know the identity of study treatments), placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial)-controlled study in approximately 1,000 medically or surgically castrated male patients with metastatic CRPC who have shown tumor progression and are asymptomatic or mildly symptomatic. The study period will consist of screening, treatment, and follow-up phases. Patients will receive study treatment (abiraterone acetate or placebo) plus prednisone until radiographic progression of disease and/or unequivocal clinical progression. Efficacy evaluations will be performed throughout the treatment period and safety will be assessed until 30 days after the last dose of abiraterone acetate. throughout the study. Follow-up will continue for up to 60 months (5 years) or until the patient dies, is lost to follow-up, or withdraws informed consent. At the interim analysis of overall survival (OS; 43% of death events), the independent data monitoring committee (IDMC) reviewed the efficacy and safety data and concluded that all of the data pointed to a significant advantage for patients in one arm of the study compared with the other arm thereby unanimously recommending unblinding the study and allowing crossover from the placebo arm to active therapy. Patients currently receiving placebo will be offered crossover therapy to abiraterone acetate. Treatment for patients who were originally randomized to the abiraterone acetate treatment group will not change. Patients will be discontinued from long term follow-up at the time of the Clinical Cut-Off Date for Final Analysis (CCO-FA); however, patients still receiving treatment with abiraterone acetate at the CCO-FA will be offered to receive continued treatment for an additional period of up to 3 years or until disease progression or unacceptable toxicity. For these patients, safety assessment will be performed while continuing treatment, and for 30 days after the last dose of abiraterone acetate.
Study Type  ICMJE Interventional
Study Phase Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer
Intervention  ICMJE
  • Drug: Abiraterone acetate
    1000 mg per day (4 x 250-mg tablets) taken orally.
  • Drug: Placebo
    4 placebo tablets per day taken orally.
  • Drug: Prednisone
    5 mg tablet orally twice daily.
Study Arms
  • Placebo Comparator: Placebo + prednisone
    Placebo plus prednisone
    Interventions:
    • Drug: Placebo
    • Drug: Prednisone
  • Experimental: Abiraterone + prednisone
    Abiraterone acetate plus prednisone
    Interventions:
    • Drug: Abiraterone acetate
    • Drug: Prednisone
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 15, 2012)
1088
Original Estimated Enrollment  ICMJE
 (submitted: April 22, 2009)
1000
Actual Study Completion Date May 25, 2017
Actual Primary Completion Date March 31, 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Metastatic castration-resistant prostate cancer (CRPC)
  • Previous anti-androgen therapy and progression after withdrawal
  • ECOG performance status of either 0 or 1
  • Medical or surgical castration with testosterone less than 50 ng/dL
  • Life expectancy of at least 6 months

Exclusion Criteria:

  • Prior cytotoxic chemotherapy or biologic therapy for CRPC
  • Prior ketoconazole for prostate cancer
  • Known brain metastasis or visceral organ metastasis
  • Use of opiate analgesics for cancer-related pain, including codeine and dextropropoxyphene, currently or anytime within 4 weeks of Cycle 1 Day 1
Sex/Gender
Sexes Eligible for Study: Male
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Belgium,   Canada,   France,   Germany,   Greece,   Netherlands,   Spain,   Sweden,   United Kingdom,   United States
Removed Location Countries Italy,   Niger
 
Administrative Information
NCT Number  ICMJE NCT00887198
Other Study ID Numbers  ICMJE CR016927
COU-AA-302 ( Other Identifier: Janssen Research & Development, LLC )
2008-008004-41 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Janssen Research & Development, LLC
Study Sponsor  ICMJE Janssen Research & Development, LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
PRS Account Janssen Research & Development, LLC
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP