RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. PURPOSE: This phase II trial is studying the side effects of everolimus and to see how well it works as first-line therapy in treating patients with prostate cancer.
OBJECTIVES: Primary * Determine the progression-free survival at 12 weeks of patients with non-rapidly progressive castration-resistant prostate cancer treated with everolimus as first-line therapy. * Assess the activity and safety of this regimen in these patients. Secondary * Determine the progression-free survival at 24 weeks of patients treated with this regimen. * Determine the percentage of PSA response from baseline to 12 weeks in patients treated with this regimen. * Determine the changes in PSA-doubling time in patients treated with this regimen. * Determine the overall survival of patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive oral everolimus once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study therapy, patients are followed up at 28 days and then every 3 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
37
Everolimus: 10mg daily
Kantonspital Aarau
Aarau, Switzerland
Kantonsspital Baden
Baden, Switzerland
Universitaetsspital-Basel
Basel, Switzerland
Progression-free survival (PFS) at 12 weeks
PFS at 12 weeks is defined as the absence of disease progression or death at 12 weeks after start of treatment.
Time frame: at 12 weeks
PFS at 24 weeks
PFS at 24 weeks is defined as the absence of any disease progression or death at 24 weeks after start of treatment.
Time frame: at 24 weeks
Progression-free survival
from start of treatment until progression or death of any cause, whereas it will be censored at the last follow-up visit or initiation of a different treatment.
Time frame: from start of treatment until progression or death of any cause
Adverse events (AEs) according to NCI CTCAE v. 3.0
All AEs will be assessed according to NCI CTCAE v3.0
Time frame: from start of treatment until progression or death of any cause
PSA response
50% PSA response is defined as a decrease in PSA level of at least 50% (compared to baseline PSA). 30% PSA response is defined as a decrease in PSA level of at least 30% (compared to baseline PSA). Best response is defined as the percentage of change in PSA from baseline to the maximum decline in PSA at any point under treatment. Response at 12 weeks is defined as the percentage of change in PSA from baseline to 12 weeks (or earlier for those patients who discontinue therapy, in this case last PSA values recorded should be taken).
Time frame: 50% and 30%, best and at 12 weeks
Changes in PSA-doubling time
PSA-DT is calculated by natural log of 2 divided by the slope of the relationship between the log of PSA and time of PSA measurement for each patient.
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Inselspital Bern
Bern, Switzerland
Spitalzentrum Biel
Biel, Switzerland
Kantonsspital Graubuenden
Chur, Switzerland
Hopital Cantonal Universitaire de Geneve
Geneva, Switzerland
Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland
Kantonsspital Luzern
Lucerne, Switzerland
Kantonsspital - St. Gallen
Sankt Gallen, Switzerland
...and 3 more locations
Time frame: Time points for later calculations include: after 12 weeks, after 24 weeks and at best PSA response
Tumor assessment of measurable disease according to RECIST v1.1 criteria
For patients with measurable disease at baseline RECIST v1.1 will be used to define CR, PR, SD and PD.
Time frame: The first assessment will be performed after 12 weeks of treatment, or earlier if clinically indicated.
Tumor assessment of bone lesions
Bone metastases can be assessed by radionuclide bone scan.
Time frame: at 12 weeks.