Clinical trial · Interventional
Trilostane for Androgen-Independent Prostate Cancer
A Phase II Study of Trilostane for Androgen-Independent Prostate Cancer
NCT00181597CI-TRIAL-00012802completedPhase 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 main purpose of this study is to test the safety of trilostane by looking at what effects, good and bad, it 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 |
|---|---|---|---|
| Prostate Adenocarcinoma | Prostate Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hydrocortisone | Drug | — | UNRESOLVED |
| Trilostane | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- activity of trilostane in men with androgen-independent prostate cancer.
- timeFrame
- 4 years
Secondary outcomes (1)
- measure
- serum levels of gonadal and adrenal steroids
- timeFrame
- 4 years
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed prostate adenocarcinoma * Disease progression despite androgen depravation therapy and antiandrogen withdrawal * Progressive measurable disease or bone scan progression or PSA progression * Serum total testosterone \< 50ng/ml * Creatinine \< 2.0 mg/dl * ALT \< 2 x ULN * CALGB performance status of 0,1, or 2 Exclusion Criteria: * Radiation therapy within 4 weeks * Antiandrogen within 8 weeks * Other secondary hormonal therapy or investigational agents within 4 weeks * Prior chemotherapy for androgen-independent prostate cancer * History of adrenal insufficiency * Known brain metastases * Severe liver or renal disease
References
Publications (0)
Data not yet available
No reference posted for this study.