A Pilot Trial of Calcitriol in Localized Prostate Cancer: Investigation of Biologic Effects and Potential Intermediate Endpoints
18 Years
N/A
Male
Prostate Cancer
Trial Information
A Pilot Trial of Calcitriol in Localized Prostate Cancer: Investigation of Biologic Effects and Potential Intermediate Endpoints
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Effect of preoperative high-dose calcitriol and dexamethasone on prostatic tumor vessel density measured at 1, 2, 3, and 12 months post prostatectomy
Safety Issue:
No
Principal Investigator
Donald L. Trump, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Roswell Park Cancer Institute
Authority:
United States: Food and Drug Administration
Study ID:
CDR0000365693
NCT ID:
NCT00084864
Start Date:
September 2002
Completion Date:
May 2010
Related Keywords:
- Prostate Cancer
- adenocarcinoma of the prostate
- stage II prostate cancer
- stage III prostate cancer
- Adenocarcinoma
- Prostatic Neoplasms
Name | Location |
|---|---|
| Roswell Park Cancer Institute | Buffalo, New York 14263 |
