NCT02516670

Docetaxel With or Without Ascorbic Acid in Treating Patients With Metastatic Prostate Cancer

A Randomized Phase 2 Trial of Ascorbic Acid in Combination With Docetaxel in Men With Metastatic Prostate Cancer

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hormone-Resistant Prostate Cancer
• Metastatic Prostate Carcinoma
• Stage IV Prostate Cancer

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Ascorbic Acid	Given IV
DRUG	Docetaxel	Given IV
OTHER	Laboratory Biomarker Analysis	Correlative studies
OTHER	Pharmacological Study	Correlative studies
OTHER	Placebo	Given IV
OTHER	Quality-of-Life Assessment	Ancillary studies

Timeline

• Start date: 2016-06-20
• Primary completion: 2021-07-31
• Completion: 2021-10-14
• First posted: 2015-08-06
• Last updated: 2023-06-07
• Results posted: 2022-08-08

Locations

6 sites across 1 country: United States