Status:
TERMINATED
Calcitriol and Dexamethasone Before Radical Prostatectomy in Treating Patients With Localized Adenocarcinoma (Cancer) of the Prostate
Lead Sponsor:
Roswell Park Cancer Institute
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Prostate Cancer
Eligibility:
MALE
18-120 years
Phase:
PHASE2
Brief Summary
RATIONALE: Calcitriol and dexamethasone may slow the growth of prostate cancer cells. PURPOSE: This randomized phase II trial is studying how well giving calcitriol together with dexamethasone before...
Detailed Description
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 effe...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00084864
Start Date
September 1 2002
End Date
May 1 2010
Last Update
June 12 2017
Active Locations (1)
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1
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001