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NCT Number: NCT00022412

Doxercalciferol Before Surgery in Treating Localized Prostate Cancer

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

21 year–120 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Holden Comprehensive Cancer Center at University of Iowa, Iowa City, Iowa, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

doxercalciferol

Dietary Supplement

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

Other names: Localized adenocarcinoma of the prostate

conventional surgery

Procedure

Procedure: Prostatectomy for prostate cancer

Other names: Prostatectomy - no dietary supplement

Primary outcomes

  1. Intermediate endpoint biomarker modulation

    Time frame: 18 months

  2. Toxicity

    Time frame: 30 months

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study 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

Important dates

Study start
2001
Primary completion
2006
Study completion
2008
First posted
Jan 27, 2003
Registry last updated
Dec 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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