Clinical trial NCT00022412: Doxercalciferol Before Surgery in Treating Localized Prostate Cancer
Official title: Phase II Open Label, Multi-Center Clinical Trial Of Modulation Of Intermediate Endpoint Biomarkers By 1x-Hydroxyvitamin D2 In Patients With Clinically Localized Prostate Cancer And High Grade PIN
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: adenocarcinoma of the prostate
stage I prostate cancer
stage II prostate cancer
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-01-27
Enrollment: 60
Sex: MALE
Minimum age (years): 21
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: RATIONALE: Doxercalciferol may be an effective way to treat localized prostate cancer before surgery.

PURPOSE: Randomized phase II trial to study the effectiveness of giving doxercalciferol before surgery in treating patients who have localized prostate cancer.

Detailed description: OBJECTIVES:

* Determine whether doxercalciferol modulates intermediate endpoint biomarkers in the development of prostate cancer in patients with localized prostate cancer.
* Assess the toxicity of this drug in these patients.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to one of 2 arms.

* Arm I: Patients receive doxercalciferol once daily for 28 days. Patients then undergo prostatectomy.
* Arm II: Patients undergo observation for 28 days. Patients then undergo prostatectomy.

PROJECTED ACCRUAL: A total of 60 patients (30 per arm) will be accrued for this study within 18 months.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Histologically or cytologically confirmed localized adenocarcinoma of the prostate
* Candidate for prostatectomy

PATIENT CHARACTERISTICS:

Age:

* 21 and over

Performance status:

* Not specified

Life expectancy:

* Not specified

Hematopoietic:

* WBC at least 4,000/mm\^3
* Platelet count at least 100,000/mm\^3

Hepatic:

* Bilirubin no greater than 1.4 mg/dL
* AST no greater than 3 times normal

Renal:

* Creatinine no greater than 2.0 mg/dL
* Calcium no greater than 10.2 mg/dL
* No idiopathic urinary calcium stone disease

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* Not specified

Endocrine therapy:

* No prior hormonal therapy for prostate cancer
* No concurrent hormonal therapy, including luteinizing hormone-releasing hormone agonists, antiandrogens, glucocorticoids, ketoconazole, finasteride, diethylstilbestrol, or progestins

Radiotherapy:

* No prior brachytherapy or external beam radiotherapy for prostate cancer

Surgery:

* See Disease Characteristics

Other:

* At least 7 days since prior vitamin D therapy or calcium supplements
* No other concurrent vitamin D analogues or calcium supplements
* No concurrent magnesium-containing antacids
* No concurrent thiazide-containing diuretics
* No concurrent phenytoin, phenobarbital, glutethimide, digoxin, or digitalis

Primary outcomes:
measure: Intermediate endpoint biomarker modulation
timeFrame: 18 months
measure: Toxicity
timeFrame: 30 months
Secondary outcomes:
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: Holden Comprehensive Cancer Center at University of Iowa
state: Iowa
city: Rochester
country: United States
facility: James P. Wilmot Cancer Center at University of Rochester Medical Center
state: New York
city: Madison
country: United States
facility: Veterans Affairs Medical Center - Madison
state: Wisconsin
city: Madison
country: United States
facility: Meriter Hospital
state: Wisconsin
city: Madison
country: United States
facility: University of Wisconsin Comprehensive Cancer Center
state: Wisconsin
city: Milwaukee
country: United States
facility: Medical College of Wisconsin Cancer Center
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: George Wilding, MD
role: STUDY_CHAIR
References: