Doxercalciferol Before Surgery in Treating Localized Prostate Cancer

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00022412

Enrollment

Registered

2003-01-27

Start date

2001-08-31

Completion date

2008-08-31

Last updated

2019-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostate, stage I prostate cancer, stage II prostate cancer

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.

Interventions

DIETARY_SUPPLEMENTdoxercalciferol

Arm 1: Patients receive doxercalciferol once daily for 28 days. Patients then undergo prostatectomy.

PROCEDUREconventional surgery

Procedure: Prostatectomy for prostate cancer

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

21 Years to 120 Years

Healthy volunteers

Inclusion 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

Design outcomes

Primary

Measure	Time frame
Intermediate endpoint biomarker modulation	18 months
Toxicity	30 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026