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

AstraZeneca30 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Prostate Cancer

Interventions

GefitinibDRUG

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Research Site

Helsinki, Finland

Outcomes

Primary Outcomes

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 Outcomes

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)

Data from ClinicalTrials.gov

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