A Randomized Phase 2 Trial of Ascorbic Acid in Combination with Docetaxel in Men with Metastatic Prostate Cancer
Johns Hopkins Kimmel Cancer Center in Baltimore
Sibley Memorial Hospital
To determine whether the proportion of patients with greater than 50% PSA decline over 8 cycles of therapy is higher in the docetaxel with IV ascorbic arm versus the docetaxel and placebo arm. In addition, this study will help determine if the proportion of side effects reported in the docetaxel plus IV ascorbic acid arm are lower compared to the docetaxel and placebo arm.
Patient must meet all eligibility criteria to be enrolled in the study. Below is the portion of the study requirements: have a pathological diagnosis of prostate cancer and have prostate cancer progressing despite castrate levels of testosterone less than 50ng/dL. Patient must not have received prior chemo treatment (six cycles of prior docetaxel and have been off docetaxel for at least 12 months is allowed). Patient may be receiving continuous hormonal ablation with surgical or medical castration with baseline testosterone less than 50ng/dL. Patients may be receiving bone targeted agents.
This is a multi-center, double-blinded, placebo-controlled, randomized phase 2 trial of docetaxel with and without I.V. ascorbic acid. The patients will be assigned either to Arm A and treated with Docetaxel IV once every three weeks for a total of eight cycles and Ascorbic acid I.V three times a week OR Arm B treated with Docetaxel I.V. once every three weeks and placebo I.V three times a week.
01/19/2020 05:03 AM