Lauren Harshman
Abiraterone Acetate in Asymptomatic or Mildly Symptomatic Patients With Metastatic Castration-Resistant Prostate Cancer
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
This is a phase 3 study to compare the clinical benefit of abiraterone acetate plus prednisone with placebo plus prednisone in patients with asymptomatic or mildly symptomatic patients with metastatic castration-resistant prostate cancer.
Recruiting Status:
RecruitingStanford Recruiting Status:
RecruitingCondition(s):
Intervention(s):
- Drug: abiraterone acetate plus prednisone/prednisolone
- Drug: placebo plus prednisone/prednisolone
Phase:
Phase 3Eligibility
Ages Eligible for Study:
18 years to Any AgeGenders Eligible for Study:
MaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key Inclusion Criteria:
- Metastatic castration-resistant prostate cancer
- 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
- Able to provide written informed consent
Key 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
Please note that there are additional inclusion and exclusion criteria. The study center will determine if you meet all of the criteria.
Site personnel will explain the trial in detail and answer any question you may have if you do qualify for the study. You can then decide whether or not you wish to participate. If you do not qualify for the trial, site personnel will explain the reasons.
Additional Study Details
Official Title:
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 CancerAnticipated start date:
7/8/2009Lead Sponsor:
Cougar Biotechnology, Inc.Investigator(s):
Study Type:
InterventionalPurpose:
TreatmentAllocation:
RandomizedMasking:
Double BlindControl:
noneAssignment:
ParallelEndpoints:
Safety/EfficacyPrimary Outcomes:
- Overall Survival (OS) and Progression-Free Survival [ Time Frame: Every 3 months while on study and during follow up ] [ Designated as safety issue: No ]
Total Number to be Enrolled:
1000Total Number to be Enrolled at Stanford:
10More Information
Secondary ID(s):
- COU-AA-302
- NCT00887198
- PROS0029
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.
This listing was last updated:
8/18/2009PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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