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

NCT ID: NCT00241475

Last Updated: 2009-04-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-12-31
• Study Completion Date: 2005-10-31

Brief Summary

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

Conditions

Prostate Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Gefitinib

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: lead

Principal Investigators

AstraZeneca Finland Medical Director, MD

Role: STUDY_DIRECTOR

AstraZeneca Finland

Locations

Research Site

Helsinki, , Finland

Countries

Finland

Other Identifiers

1839IL/0155

Identifier Type: -

Identifier Source: org_study_id