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Hormone Therapy
Bicalutamide With or Without Everolimus in Treating Patients With Recurrent or Metastatic Prostate Cancer (UCDCC#215 Trial)
Phase 2
Waitlist Available
Led By Chong-Xian Pan, MD, PhD
Research Sponsored by University of California, Davis
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
Approved for 10 Other Conditions
All Individual Drugs Already Approved
No Placebo-Only Group
Summary
RATIONALE: Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as bicalutamide, may lessen the amount of androgens made by the body. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying bicalutamide and everolimus to see how well they work compared with bicalutamide in treating patients with recurrent or metastatic prostate cancer.
Eligible Conditions
- Prostate Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
PSA Response Rate
Secondary study objectives
Overall Survival
Progression-free Survival
Awards & Highlights
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Bicalutamide + EverolimusExperimental Treatment2 Interventions
Patients receive oral bicalutamide and oral everolimus once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bicalutamide
FDA approved
Everolimus
FDA approved
Find a Location
Who is running the clinical trial?
University of California, DavisLead Sponsor
946 Previous Clinical Trials
4,756,114 Total Patients Enrolled
12 Trials studying Prostate Cancer
1,775 Patients Enrolled for Prostate Cancer
NovartisIndustry Sponsor
1,639 Previous Clinical Trials
2,774,279 Total Patients Enrolled
21 Trials studying Prostate Cancer
4,910 Patients Enrolled for Prostate Cancer
Chong-Xian Pan, MD, PhDPrincipal InvestigatorUniversity of California, Davis