Calcitriol and Dexamethasone Before Radical Prostatectomy in Treating Patients With Localized Adenocarcinoma (Cancer) of the Prostate

• Status: Terminated
• Trial end date: 2010-05-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Roswell Park Cancer Institute
• Collaborator: National Cancer Institute (NCI)
• Treatments: BB 1101; Calcitriol; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate

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