Oral Colchicine in Men With Castrate Resistant Prostate Cancer

Study Overview
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Brief Summary
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The purpose of this study is to determine the prostate specific antigen response to continuous low dose oral colchicine.

Detailed Description
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The investigators propose a simple phase II trial of oral colchicine at the standard prophylactic dose utilized for gout in men with CRPCa who have failed taxotere based chemotherapy. The investigators will utilize a simple modified Simon 2-stage design. The investigators plan to enroll 40 men for the study. The men should have completed prior taxotere based therapy or any other therapy post-taxotere including cabazitaxel one month prior to receipt of colchicine on trial. Staging with a baseline bone scan, CT and PSA as well as routine CBC, CMP and PAP. The dose of the drug can be escalated as tolerated to a maximum of 1.2 mg bid. The patient would be seen at 21 day intervals. After every 3 cycles of treatment, patient would be restaged with CT and bone scan. Patients with stable disease, partial response or complete response would continue therapy until either disease progression or intolerable toxicity after which the patient would be taken off study.

Official Title
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Phase II Trial of Oral Colchicine in Men With Castrate-Resistant Prostate Cancer Who Have Failed Taxotere-Based Chemotherapy

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: Colchicine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single arm<br>Colchicine 0.5 mg BID x 21 days | Drug: Colchicine<br>* Colchicine 0.6 mg bid to a maximum of 1.2 mg bid<br>* Other names: Colcrys;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PSA Response rate | Determine the PSA response rate to continuous low dose oral colchicine | 63 days (3 cycles of treatment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate | Determine the progression free survival | 63 days (3 cycles) | 
| Toxicity grading | Determine the safety and tolerability of continuous low dose oral colchicine | One year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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oral colchicine, castrate-resistant prostate cancer, failed taxotere based chemotherapy