Conditions: Prostate Cancer
Keywords: adenocarcinoma of the prostate stage II prostate cancer stage III prostate cancer
Allocation: RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 25
Healthy volunteers: no

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

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 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.

Arms:
arm 1: 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. arm 2: No study drugs before surgery. arm 3: Patients receive oral dexamethasone once daily on days 1-4. arm 4: Patients receive oral calcitriol once daily on days 2-4.

Interventions: intervention 1: calcitriol intervention 2: dexamethasone intervention 3: clinical observation
Intervention descriptions: intervention 1: Given orally intervention 2: Given orally intervention 3: No intervention before surgery

Protocol document: