Everolimus as First-Line Therapy in Treating Patients With Prostate Cancer

Phase 2

Completed

• Conditions: Prostate Cancer
• Interventions: Drug: everolimus

• Registration Number: NCT00976755
• Lead Sponsor: Swiss Group for Clinical Cancer Research

Brief Summary

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.

Detailed Description

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 Timeline

• Study First Submitted: 2009-09-11
• Study First Submitted QC: 2009-09-11
• Study Start: 2009-09-14
• Study First Posted: 2009-09-14
• Primary Completion: 2012-11-29
• Status Verified: 2019-08
• Study Completion: 2019-08-08
• Last Update Submitted: 2019-08-08
• Last Update Posted: 2019-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 37

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm A: Everolimus	everolimus	Everolimus: 10mg daily

Primary Outcome Measures

Name	Time	Method
Progression-free survival (PFS) at 12 weeks	at 12 weeks	PFS at 12 weeks is defined as the absence of disease progression or death at 12 weeks after start of treatment.

Secondary Outcome Measures

Name	Time	Method
PFS at 24 weeks	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.
Progression-free survival	from start of treatment until progression or death of any cause	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.
Adverse events (AEs) according to NCI CTCAE v. 3.0	from start of treatment until progression or death of any cause	All AEs will be assessed according to NCI CTCAE v3.0
PSA response	50% and 30%, best and at 12 weeks	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).
Changes in PSA-doubling time	Time points for later calculations include: after 12 weeks, after 24 weeks and at best PSA response	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.
Tumor assessment of measurable disease according to RECIST v1.1 criteria	The first assessment will be performed after 12 weeks of treatment, or earlier if clinically indicated.	For patients with measurable disease at baseline RECIST v1.1 will be used to define CR, PR, SD and PD.
Tumor assessment of bone lesions	at 12 weeks.	Bone metastases can be assessed by radionuclide bone scan.

Trial Locations

Locations (12)

Universitaetsspital-Basel; 🇨🇭 Basel, Switzerland

Kantonspital Aarau; 🇨🇭 Aarau, Switzerland

Kantonsspital Baden; 🇨🇭 Baden, Switzerland

Centre Hospitalier Universitaire Vaudois; 🇨🇭 Lausanne, Switzerland

Inselspital Bern; 🇨🇭 Bern, Switzerland

Kantonsspital Graubuenden; 🇨🇭 Chur, Switzerland

Spitalzentrum Biel; 🇨🇭 Biel, Switzerland

Kantonsspital Luzern; 🇨🇭 Luzern, Switzerland

Kantonsspital - St. Gallen; 🇨🇭 St. Gallen, Switzerland

Kantonsspital Winterthur; 🇨🇭 Winterthur, Switzerland

Hopital Cantonal Universitaire de Geneve; 🇨🇭 Geneva, Switzerland

UniversitaetsSpital Zuerich; 🇨🇭 Zurich, Switzerland