Clinical trial · Interventional
Oral Colchicine in Men With Castrate Resistant Prostate Cancer
Phase II Trial of Oral Colchicine in Men With Castrate-Resistant Prostate Cancer Who Have Failed Taxotere-Based Chemotherapy
NCT01481233CI-TRIAL-00012285withdrawnPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Due to funding
Summary
Brief summary (as posted)
The purpose of this study is to determine the prostate specific antigen response to continuous low dose oral colchicine.
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 |
|---|---|---|---|
| Colchicine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single arm
- description
- Colchicine 0.5 mg BID x 21 days
- interventionNames
- Drug: Colchicine
Primary outcomes (1)
- measure
- PSA Response rate
- timeFrame
- 63 days (3 cycles of treatment)
- description
- Determine the PSA response rate to continuous low dose oral colchicine
Secondary outcomes (2)
- measure
- Response rate
- timeFrame
- 63 days (3 cycles)
- description
- Determine the progression free survival
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Castrate resistant prostate cancer * Failure or intolerance of taxotere or cabazitaxel-based chemotherapy or abiraterone administered for castrate resistant prostate cancer is allowed * Age \> 18 years and ability to provide informed consent * ECOG performance status of 0, 1 or 2 * No prior use of colchicine within the last 2 years * No chemotherapy, hormonal therapy, immunotherapy or radiation therapy within 1 month of day 1, cycle 1 Exclusion Criteria: * Inability to provide informed consent * Hypersensitivity to colchicine * Severe renal, gastrointestinal or hepatic disorders * Pre-existing blood dyscrasia * PLT \< 100K, ANC \< 1000 * Serum Cr \> 2 x ULN * Bilirubin \> 2 ULN * AST \> 2 x ULN * Concurrent use of CYP3A4 inhibitors which may increase drug levels and toxicity
References
Publications (0)
Data not yet available
No reference posted for this study.