A Phase 2 interventional study of doxercalciferol and conventional surgery in Prostate Cancer, sponsored by University of Wisconsin, Madison. Completed at 6 sites in United States. Open to male participants aged 21 Years to 120 Years. Per ClinicalTrials.gov, last updated 2019-12-13.
Sponsored by University of Wisconsin, Madison · Phase 2, Interventional, and Treatment
RATIONALE: Doxercalciferol may be an effective way to treat localized prostate cancer before surgery.
PURPOSE: Randomized phase II trial to study the effectiveness of giving doxercalciferol before surgery in treating patients who have localized prostate cancer.
OBJECTIVES:
OUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to one of 2 arms.
PROJECTED ACCRUAL: A total of 60 patients (30 per arm) will be accrued for this study within 18 months.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's planned enrollment of 60 is close to the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →University of Wisconsin, Madison is the lead sponsor of 1,161 studies on the registry; 182 are open to participants now.
Of its 151 completed or terminated interventional studies of FDA-regulated products, 114 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Arm 2: Patients undergo observation for 28 days. Patients then undergo prostatectomy.
Procedure: conventional surgery
Dietary supplement once daily to treat prostate cancer for 28 days
Dietary Supplement: doxercalciferol
Arm 1: Patients receive doxercalciferol once daily for 28 days. Patients then undergo prostatectomy.
Also known as: Localized adenocarcinoma of the prostate
Procedure: Prostatectomy for prostate cancer
Also known as: Prostatectomy - no dietary supplement
Intermediate endpoint biomarker modulation
Time frame: 18 months
Toxicity
Time frame: 30 months
This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.
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University of Wisconsin, Madison