Docetaxel With or Without Ascorbic Acid in Treating Patients With Metastatic Prostate Cancer
Summary
This randomized phase II trial studies how well docetaxel works when given with or without ascorbic acid in treating patients with prostate cancer that has spread to other places in the body. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Ascorbic acid (vitamin C) is a water-soluble vitamin that may help inhibit the growth of cancer cells. It is not yet known whether docetaxel works better when given with or without ascorbic acid in treating prostate cancer.
Timeline
- Start
- 2016-06-20
- Primary completion
- 2021-07-31
- Completion
- 2021-10-14
Outcome
Missed primary endpoint
Stopped: “insufficient clinical response per DSMB”
paper The PSA50 response rate was 41% in the HDIVC group and 33% in the placebo group (P = 0.44), with comparable adverse event rates in both groups. PMID 39076107 ↗
paper The study was suspended after prespecified interim analysis indicated futility in achieving primary endpoints. PMID 39076107 ↗
paper combining HDIVC with docetaxel did not improve PSA response, toxicity, or other clinical outcomes compared with docetaxel alone. PMID 39076107 ↗