Clinical trial · Interventional
Mifepristone (RU-486) in Androgen Independent Prostate Cancer
A Phase II Study of Mifepristone (RU-486) in Androgen Independent Prostate Cancer With Correlative Assessment of Androgen Receptor Co-Repressor Proteins
NCT00140478CI-TRIAL-00002873completedPhase 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)
The purpose of this study is to determine the effects (good and bad) that mifepristone has on patients with androgen independent prostate cancer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenocarcinoma of Prostate | Prostate Adenocarcinoma | ALIAS | 0.90 |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Mifepristone | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To determine the therapeutic efficacy of mifepristone in patients with androgen independent prostate cancer
- timeFrame
- 2 years
Secondary outcomes (1)
- measure
- To determine the duration of response, time to disease progression and safety of mifepristone in patients with androgen independent prostate cancer
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologic documentation of adenocarcinoma of the prostate * Bone metastasis(es) by bone scan or cat scan * Clinical, biochemical, or radiographic progression after primary androgen ablation with either orchiectomy or gonadotropin releasing hormone analog therapy. * One prior chemotherapy treatment is allowed. * \> 3 weeks since major surgery * \> 4 weeks since radiotherapy * \> 8 weeks since prior strontium-89 or samarium 153 * ECOG performance status 0 or 1 * Absolute neutrophil count (ANC) \> 1,500/ul * Platelets \> 100,000/ul * Bilirubin \< 1.5 x upper limit of normal (ULN) * AST or ALT \< 3 x ULN * Creatinine \< 1.5 x ULN * Electrolytes within 10% of normal range * Serum testosterone \< 50ng/dL * Prostate-specific antigen (PSA) \> 5.0ng/ml Exclusion Criteria: * Concomitant therapy with corticosteroids * Chemotherapy within 28 days * Currently active second malignancy other than non-melanoma skin cancer * Baseline adrenal insufficiency requiring long-term steroids
References
Publications (0)
Data not yet available
No reference posted for this study.