Safety Study to Explore Combination of Gefitinib (ZD1839, Iressa) and Radiotherapy in Non-Metastatic Prostate Cancer

AstraZeneca42 enrolled

Overview

To estimate the safety and tolerability of 250 mg ZD1839 given concurrently with 3D-CRT in patients with non-metastatic prostate cancer

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Non-Metastatic Prostate Cancer

Interventions

Gefitinib, radiotherapyDRUG

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Biopsy confirmation of localised (T2) or locally advanced (T3) prostate cancer * PSA below 20 ng/mL * Lymph node negative * Non-metastatic * Written informed consent Exclusion Criteria: * Well differentiated stage T2 prostate cancer (Gleason score 2 to 4) * Distant or nodal metastases * Prostatectomy * Concomitant LHRH analog treatment * Previous or concomitant anti-androgens * Active ILD

Locations (1)

Research site

Helsinki, Finland

Outcomes

Primary Outcomes

Part A: Safety (incidence of DLTs)

Part B: Tolerability

Secondary Outcomes

EGFR-1 expression and activation status (autophoshorylation; p-EGFR-1) at diagnosis

Data from ClinicalTrials.gov

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