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

An Open Label, Non-Comparative, Phase II Study of ZD1839 (Iressa) as First-Line Treatment in Subjects With Relapsed Prostate Cancer Following Radical Prostatectomy or Radiotherapy

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00241475

Enrollment

Registered

2005-10-19

Start date

2003-12-31

Completion date

2005-10-31

Last updated

2009-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

Cancer of the Prostate

Brief summary

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

Interventions

DRUGGefitinib

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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)	—

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026