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 radical prostatectomy works in treating patients with localized stage II or stage III adenocarcinoma (cancer) of the prostate.

Condition	Treatment or Intervention	Phase
adenocarcinoma of the prostate stage II prostate cancer stage III prostate cancer	Drug: calcitriol  Drug: dexamethasone  Procedure: biological response modifier therapy  Procedure: chemosensitization/potentiation  Procedure: conventional surgery  Procedure: differentiation therapy  Procedure: endocrine therapy  Procedure: hormone therapy  Procedure: neoadjuvant therapy  Procedure: steroid therapy  Procedure: surgery	Phase II

Further Study Details: 

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.

• 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.
• 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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed adenocarcinoma of the prostate
• Organ-confined disease
• cT2 or cT3 tumors
• 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

• Fertile patients must use effective double barrier and hormonal contraception during and for at least 8 weeks after study participation
• 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

New York
      Roswell Park Cancer Institute, Buffalo,  New York,  14263-0001,  United States; Recruiting

Study chairs or principal investigators

Donald L. Trump, MD,  Principal Investigator,  Roswell Park Cancer Institute   

Study ID Numbers:  CDR0000365693; RPCI-RP-0212; NCT00084864
Record last reviewed:  August 2004
Last Updated:  February 24, 2005
Record first received:  June 10, 2004
ClinicalTrials.gov Identifier:  NCT00084864
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08