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Calcifidol Therapy in Men with Cancer



Calcifidol Therapy in Men with Cancer

For Condition: Prostate Cancer
Status: Recruiting
Sponsor(s): Department of Veterans Affairs Medical Research Service ,
Synopsis: Prostate cancer is a common occurrence in the aging population, with one in ten men destined to develop the disease. 40% of patients with prostate cancer experience a recurrence after definitive treatment. This study addresses the as-yet unresolved problem of the optimal management of early recurrence as manifested by increase in the accepted marker for this disease, PSA. Vitamin D, an agent with cell-differentiating properties, has been shown to inhibit angiogenesis and cause differentiation of prostate cancer cells in the laboratory and to affect PSA favorably in clinical studies of patients with advanced prostate cancer. This study will assess the effects of vitamin D in patients with sub-clinical biochemical relapses of prostate cancer as indicated by rising PSA but low tumor burdens, with the potential for developing an approach to this problem that will delay or prevent progression.
Details:
Eligibility:
Study Type:  Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Minimum Age/Maximum Age: /
Genders: Male
Protocol Entry Criteria: Patients will be males with three successive rises in PSA after achieving a nadir post-definitive therapy. The following criteria must be met: pathologically confirmed prostate cancer, completion of definitive treatment in the form of local external beam radiation or definitive surgery and three successive rises in PSA with no clinical evidence of disease.
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
GarySchwartz,  , 

VAMC Miami, FL *Recruiting*
Miami,  Florida,  33125
United States
Recruiting Gustavo  Godoy 305-324-3179


Additional Information:
Study ID Numbers:  ONCO-09-99S; 
Study Start Date: October 1999
Record last reviewed: June 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00018538

Other Prostate Cancer Studies:
1. "REDUCE" - A Clinical Research Study To Reduce The Incidence Of Prostate Cancer In Men Who Are At Increased Risk

2. Safety and Efficacy Study of Omnitarg (Pertuzumab) to Treat Castration-Resistant Prostate Cancer

3. PROSTVAC®-VF/TRICOM™ Vaccine for the Treatment of Metastatic Prostate Cancer after Failing Hormone Therapy

4. Treatment of Erectile Dysfunction (ED) in Patients Treated for Prostate Cancer

5. Preoperative Thalidomide Followed By Radical Retropubic Prostatectomy In Select Patients With Locally Advanced Prostate Cancer

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