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Calcitriol and Dexamethasone in Treating Patients With Prostate Cancer Who Have Undergone Surgery or Radiation Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00054522
Recruitment Status : Completed
First Posted : February 6, 2003
Last Update Posted : March 8, 2011
Information provided by:
Roswell Park Cancer Institute

Brief Summary:

RATIONALE: Calcitriol may help tumor cells develop into normal cells. Dexamethasone may increase the effectiveness of calcitriol by making tumor cells more sensitive to the drug.

PURPOSE: Phase II trial to study the effectiveness of combining calcitriol with dexamethasone in treating patients with prostate cancer who have undergone surgery or radiation therapy.

Condition or disease Intervention/treatment Phase
Prostate Cancer Dietary Supplement: calcitriol Drug: dexamethasone Phase 2

Detailed Description:


  • Determine whether calcitriol and dexamethasone can slow the rise in prostate-specific antigen (PSA) levels in patients with early, recurrent prostate cancer after prior radical prostatectomy or radiotherapy.
  • Determine the safety of this regimen in these patients.
  • Determine the utility of serum PSA in monitoring the therapeutic effect of calcitriol in these patients.

OUTLINE: Patients are stratified according to prior therapy (radical prostatectomy vs radiotherapy).

Patients receive oral calcitriol once daily on days 1-3 alone on week 1. Beginning on week 3, patients receive calcitriol as in week 1 and oral dexamethasone on days 0-4. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 56 patients (28 per stratum) will be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Calcitriol + Dexamethasone in Early, Recurrent Prostate Cancer Following Local Therapy, A Phase I/II Trial
Study Start Date : April 2002
Actual Primary Completion Date : January 2006
Actual Study Completion Date : March 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No


  • Histologically confirmed adenocarcinoma of the prostate meeting all of the following criteria:

    • Curatively treated with radical prostatectomy OR definitive radiotherapy
    • No signs of clinical recurrence or dissemination of prostate cancer by digital rectal examination without tumor
    • No local recurrence by CT scan or MRI of the pelvis
    • No metastases by bone scan and chest x-ray NOTE: Prior Prostascint scans allowed regardless of results
  • At least 3 prostate-specific antigen (PSA) measurements obtained over at least 90 days after radical prostatectomy on post-radiotherapy PSA nadir must be available

    • PSA at least 2 ng/mL after prostatectomy OR at least 4 ng/mL after prior radiotherapy
    • Patients previously treated with radiotherapy must have a PSA clearly rising from lowest value within 6 months after completion of therapy



  • 18 and over

Performance status

  • ECOG 0-1

Life expectancy

  • At least 12 months


  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 10 g/dL


  • Bilirubin no greater than upper limit of normal (ULN)
  • Alkaline phosphatase no greater than 2 times ULN


  • Creatinine less than 1.8 mg/dL
  • Phosphorus normal
  • No hypercalcemia (albumin-corrected calcium greater than ULN)
  • No nephrolithiasis

    • Single episode of renal lithiasis allowed provided episode occurred more than 5 years prior to study


  • Fertile patients must use effective double-barrier contraception for at least 1 week before, during, and for at least 2 weeks after study
  • No symptomatic pancreatitis
  • No uncontrolled diabetes
  • No known or suspected inability to comply with study requirements (e.g., abuse of alcohol/drugs or psychotic states)
  • Curatively treated condition associated with renal stones (e.g., hyperparathyroidism, bladder dysfunction, or obstructive uropathy) allowed provided patient has been free of stone formation for more than 5 years


Biologic therapy

  • Not specified


  • No prior chemotherapy for prostate cancer
  • At least 24 months since prior chemotherapy for other diseases

Endocrine therapy

  • More than 6 months since prior hormonal therapy, including neoadjuvant or adjuvant androgen deprivation therapy (e.g., luteinizing hormone-releasing hormone analogue or antiandrogen)
  • No prior androgen deprivation therapy of more than 8 months duration
  • No prior hormonal therapy for prostate cancer more than 3 months after definitive local therapy
  • No concurrent androgen therapy


  • See Disease Characteristics
  • More than 3 months since prior radiotherapy for locally recurrent prostate cancer
  • No concurrent radiotherapy, including for pain control


  • See Disease Characteristics


  • More than 4 weeks since prior investigational drugs
  • No concurrent medication known to affect systemic calcium metabolism, including any of the following:

    • More than 400 IU of cholecalciferol supplements
    • More than 500 IU of vitamin A supplements
    • Calcium supplements
    • Fluoride
    • Antiepileptics

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00054522

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United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
United States, Pennsylvania
Hillman Cancer Center at University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States, 15232
Sponsors and Collaborators
Roswell Park Cancer Institute
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Study Chair: Donald L. Trump, MD Roswell Park Cancer Institute

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Responsible Party: Donald Trump, MD, Roswell Park Cancer Institute Identifier: NCT00054522     History of Changes
Other Study ID Numbers: CDR0000270758
First Posted: February 6, 2003    Key Record Dates
Last Update Posted: March 8, 2011
Last Verified: March 2011
Keywords provided by Roswell Park Cancer Institute:
adenocarcinoma of the prostate
recurrent prostate cancer
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Calcium Channel Agonists
Membrane Transport Modulators
Vasoconstrictor Agents