Gefitinib in the Treatment of the First Relapse of Prostate Cancer Beyond Prostatectomy or Radiotherapy

Phase 2

Completed

• Conditions: Prostate Cancer

• Registration Number: NCT00241475
• Lead Sponsor: AstraZeneca

Brief Summary

To evaluate activity of gefitinib in subjects with relapsed prostate cancer by estimating PSA response rate at study closure

Detailed Description

Not available

Study Timeline

• Study Start: 2003-12
• Study Completion: 2005-10
• Study First Submitted: 2005-10-18
• Study First Submitted QC: 2005-10-18
• Study First Posted: 2005-10-19
• Status Verified: 2009-04
• Last Update Submitted: 2009-04-22
• Last Update Posted: 2009-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 30

Inclusion Criteria

• Relapsed prostate cancer after prostatectomy or radiotherapy
• PSA levels below 10 ng/mL
• Lymph node negative
• Metastasis negative
• Withdrawal of hormone therapy at least 6 months before entry into the study
• Written informed consent

Exclusion Criteria

• Metastatic disease
• Hormonal treatment 6 months before study entry
• Concomitant radiotherapy, surgery and/or chemotherapy
• ILD

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
PSA response rate at statistical study closure based on the percentage of subjects experiencing PSA normalization or a > 50% reduction in PSA levels compared with study entry sustained for 3 months (i.e. three consecutive measurements)

Secondary Outcome Measures

Name	Time	Method
TTF (failure defined as a need for additional/alternative therapy due to PSA progression, metastases or AEs)
Duration of PSA response
PFS (progression defined as doubling in PSA levels compared with the PSA level at study entry)

Trial Locations

Locations (1)

Research Site; 🇫🇮 Helsinki, Finland