The purpose of this study is to determine the prostate specific antigen response to continuous low dose oral colchicine.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Colchicine 0.6 mg bid to a maximum of 1.2 mg bid
PSA Response rate
Determine the PSA response rate to continuous low dose oral colchicine
Time frame: 63 days (3 cycles of treatment)
Response rate
Determine the progression free survival
Time frame: 63 days (3 cycles)
Toxicity grading
Determine the safety and tolerability of continuous low dose oral colchicine
Time frame: One year
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