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

NCT ID: NCT00084864

Last Updated: 2017-06-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-09-30
• Study Completion Date: 2010-05-31

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Stage 1, 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.

Group Type: EXPERIMENTAL

calcitriol

Intervention Type: DIETARY_SUPPLEMENT

Given orally

dexamethasone

Intervention Type: DRUG

Given orally

Stage 1, Arm II

No study drugs before surgery.

Group Type: EXPERIMENTAL

clinical observation

Intervention Type: OTHER

No intervention before surgery

Stage 1 Arm 3

Patients receive oral dexamethasone once daily on days 1-4.

Group Type: EXPERIMENTAL

dexamethasone

Intervention Type: DRUG

Given orally

Stage 1, Arm 4

Patients receive oral calcitriol once daily on days 2-4.

Group Type: EXPERIMENTAL

calcitriol

Intervention Type: DIETARY_SUPPLEMENT

Given orally

Interventions

calcitriol

Given orally

Intervention Type: DIETARY_SUPPLEMENT

dexamethasone

Given orally

Intervention Type: DRUG

clinical observation

No intervention before surgery

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Roswell Park Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Donald L. Trump, MD

Role: PRINCIPAL_INVESTIGATOR

Roswell Park Cancer Institute

Locations

Roswell Park Cancer Institute

Buffalo, New York, United States

Countries

United States

Other Identifiers

P30CA016056

Identifier Type: NIH

Identifier Source: secondary_id

View Link

RPCI-RP-0212

Identifier Type: -

Identifier Source: secondary_id

RP 02-12

Identifier Type: -

Identifier Source: org_study_id