Clinical trial · Interventional
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
NCT00241475CI-TRIAL-00002231completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To evaluate activity of gefitinib in subjects with relapsed prostate cancer by estimating PSA response rate at study closure
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gefitinib | Drug | Gefitinib | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- 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 (3)
- measure
- TTF (failure defined as a need for additional/alternative therapy due to PSA progression, metastases or AEs)
- measure
- Duration of PSA response
- measure
- PFS (progression defined as doubling in PSA levels compared with the PSA level at study entry)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.