Doxercalciferol Before Surgery in Treating Localized Prostate Cancer
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.
- Determine whether doxercalciferol modulates intermediate endpoint biomarkers in the development of prostate cancer in patients with localized prostate cancer.
- Assess the toxicity of this drug in these patients.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to 1 of 2 arms.
- Arm I: Patients receive doxercalciferol once daily for 28 days. Patients then undergo prostatectomy.
- Arm II: Patients undergo observation for 28 days. Patients then undergo prostatectomy.
PROJECTED ACCRUAL: A total of 60 patients (30 per arm) will be accrued for this study within 18 months.
Allocation: Randomized, Control: Active Control, Masking: Open Label, Primary Purpose: Treatment
doxercalciferol, conventional surgery
Holden Comprehensive Cancer Center at University of Iowa
Active, not recruiting
National Cancer Institute (NCI)
Results (where available)
- Source: http://clinicaltrials.gov/show/NCT00022412
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
A glycoprotein that is a kallikrein-like serine proteinase and an esterase, produced by epithelial cells of both normal and malignant prostate tissue. It is an important marker for the diagnosis of prostate cancer.
A synthetic retinoid that is used orally as a chemopreventive against prostate cancer and in women at risk of developing contralateral breast cancer. It is also effective as an antineoplastic agent.
Tissue ablation of the PROSTATE performed by ultrasound from a transducer placed in the RECTUM. The procedure is used to treat prostate cancer (PROSTATIC NEOPLASMS) and benign prostatic hypertrophy (PROSTATIC HYPERPLASIA).
Proteins secreted by the prostate gland. The major secretory proteins from the human prostate gland include PROSTATE-SPECIFIC ANTIGEN, prostate-specific acid phosphatase, prostate-specific membrane antigen, and prostate-specific protein-94.
Tumors or cancer of the PROSTATE.
RATIONALE: Colony-stimulating factors, such as GM-CSF, may help the body build an effective immune response to kill tumor cells. Giving GM-CSF before surgery may be an effective treatment...
RATIONALE: Inserting the gene for interleukin-2 into a person's cancer cells may improve the body's ability to fight cancer. Using leuvectin to deliver this gene may be an effective treatm...
RATIONALE: Broxuridine may help doctors determine the rate of growth of prostate tumors and help them plan effective treatment. PURPOSE: Phase II trial to study the effectiveness of broxu...
The study involves use of a device called an endomicroscope to obtain high resolution images of microscopic structures during robot-assisted prostate cancer surgery. This feasibility study...
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving chemotherapy before surgery...
Prostate specific antigen (PSA) screening for prostate cancer has become widespread, the prostate biopsy technique has evolved, and the occurrence of low-risk prostate cancer has been increasing. Even...
Prostate cancer is one of the most seriously malignant diseases threatening men's health, and the mechanisms of its initiation and progression are not yet completely understood. Recent years have witn...
Genome-wide association studies have identified an increasing number of single nucleotide polymorphisms (SNPs) associated with prostate cancer risk. Some of these same genetic variants are also associ...
Prostate cancer is the second most prevalent cancer among men in Poland. The main methods of radical treatment are radical prostatectomy and radiotherapy. In patients who have been correctly qualified...
The aim of this study is to present the oncologic outcomes and to determine prognostic parameters of overall (OS), cancer specific survival (CSS), disease progression free survival (DPFS) and biochemi...