A Pilot Trial of Calcitriol in Localized Prostate Cancer: Investigation of Biologic Effects and Potential Intermediate Endpoints
calcitriol
+ dexamethasone
+ clinical observation
Urogenital Diseases+7
+ Genital Diseases
+ Genital Diseases, Male
Treatment Study
Summary
Study start date: September 1, 2002
Actual date on which the first participant was enrolled.OBJECTIVES: * Determine the effect of calcitriol and dexamethasone before radical prostatectomy on tumor vessel density in patients with localized adenocarcinoma of the prostate. * Determine the effect of this regimen on the extent of prostatic intraepithelial neoplasia in these patients. * Determine the effect of this regimen on the expression of apoptosis markers, p21, p27, prostate-specific antigen (PSA), prostate-specific membrane antigen, and VDR expression in tumor-associated vascular endothelial cells and endothelium derived from normal-appearing prostate and tumor in these patients. * Determine the acute effects of this regimen on serum PSA in these patients. * Determine the toxicity of this regimen in these patients. OUTLINE: This is a two-stage, randomized, pilot study. * Stage 1: Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive oral dexamethasone once daily on days 1-4 and oral calcitriol once daily on days 2-4 weekly for 4 weeks before surgery. Within 48 hours of the last dose, patients undergo radical prostatectomy. * Arm II: Patients receive no study drugs, but undergo radical prostatectomy. * Stage 2: If sufficient activity is seen with the dexamethasone and calcitriol regimen in stage 1, the study is expanded and additional patients are randomized to 1 of 4 treatment arms. * Arm I: Patients receive dexamethasone and calcitriol as in stage 1, arm I. * Arm II: Patients receive oral dexamethasone once daily on days 1-4. * Arm III: Patients receive oral calcitriol once daily on days 2-4. * Arm IV: Patients undergo radical prostatectomy as in stage 1, arm II. In arms I, II, and III, patients undergo radical prostatectomy as in stage 1, arm I. Patients are followed at 1, 3, and 12 months. PROJECTED ACCRUAL: A total of 20-80 patients (20 for stage 1 \[10 per treatment arm\] and 60 for stage 2) will be accrued for this study within 2 years.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.25 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Male
Biological sex of participants that are eligible to enroll.From 18 to 120 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the prostate * Organ-confined disease * cT1, cT2, or cT3 tumors * Patients with cT1 tumors are eligible if ≥ 1 core biopsies have ≥ 50% of the tumor OR if 50% of the cores examined contain the tumor * No small cell carcinoma of the prostate * Scheduled for radical prostatectomy PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Not specified Life expectancy * Not specified Hematopoietic * Platelet count ≥ 100,000/mm\^3 * WBC ≥ 3,500/mm\^3 Hepatic * ALT and AST ≤ 4 times normal * Bilirubin ≤ 2 mg/dL Renal * Creatinine ≤ 2 times upper limit of normal * Calcium ≤ 10.5 mg/dL * No detectable renal stones by CT scan or ultrasound Other * No history of diabetes mellitus requiring pharmacotherapy PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Not specified Endocrine therapy * More than 5 years since prior antiestrogens, antiandrogens, luteinizing hormone-releasing hormone agonists, estrogen, or progestational agents Radiotherapy * Not specified Surgery * See Disease Characteristics * No prior nephrectomy * No prior prostatic surgery * No prior cryotherapy or transurethral resection of the prostate
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.4 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalGroup III
ExperimentalGroup IV
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Roswell Park Cancer Institute
Buffalo, United StatesOpen Roswell Park Cancer Institute in Google Maps