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Phase II Randomized Pilot Study of Calcitriol and Dexamethasone Before Radical Prostatectomy in Patients With Localized Adenocarcinoma of the Prostate

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs
Phase II Treatment Closed 18 and over NCI RPCI-RP-0212
NCT00084864

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.

Entry 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

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

Patient Characteristics:

Age

18 and over

Performance status

Not specified

Life expectancy

Not specified

Hematopoietic

Platelet count ≥ 100,000/mm³
WBC ≥ 3,500/mm³

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

Expected Enrollment

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.

Outcomes

Primary Outcome(s)

Effect of preoperative high-dose calcitriol and dexamethasone on prostatic tumor vessel density measured at 1, 2, 3, and 12 months post prostatectomy

Secondary Outcome(s)

Effect of preoperative high-dose calcitriol and dexamethasone on extent of prostatic intraepithelial neoplasia (PIN) at 1, 2, 3, and 12 months post prostatectomy

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.

Trial Contact Information

Trial Lead Organizations

Roswell Park Cancer Institute

Donald Trump, MD, Principal investigator
Ph: 716-845-3499; 800-685-6825
Email: donald.trump@roswellpark.org

Registry Information

Official Title		A Pilot Trial of Calcitriol in Localized Prostate Cancer: Investigation of Biologic Effects and Potential Intermediate Endpoints

Trial Start Date		2002-09-19

Trial Completion Date		2011-12-20 (estimated)

Registered in ClinicalTrials.gov		NCT00084864

Date Submitted to PDQ		2004-04-12

Information Last Verified		2008-11-30

NCI Grant/Contract Number		CA16056

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.