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CompletedNCT00054522Updated Mar 8, 2011

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

A Phase 2 interventional study of calcitriol and dexamethasone in Prostate Cancer, sponsored by Roswell Park Cancer Institute. Completed at 2 sites in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-03-08.

Sponsored by Roswell Park Cancer Institute · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Ages
18 Years and older
Sex
Male
01

Study 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.

Read the detailed description

OBJECTIVES:

  • 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.

02

Conditions studied

  • Prostate Cancer

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Keywords

  • adenocarcinoma of the prostate
  • recurrent prostate cancer
03

In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

This study's enrollment of 15 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

Roswell Park Cancer Institute is the lead sponsor of 412 studies on the registry; 62 are open to participants now.

Of its 38 completed or terminated interventional studies of FDA-regulated products, 21 (55%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

Eligibility criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-1

Life expectancy

  • At least 12 months

Hematopoietic

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

Hepatic

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

Renal

  • 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

Other

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • 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

Radiotherapy

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

Surgery

  • See Disease Characteristics

Other

  • 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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (actual)

Interventions

  • Dietary supplementcalcitriol
  • Drugdexamethasone
06

Study locations

2 sites
  • Roswell Park Cancer Institute
    Buffalo, New York 14263-0001, United States
  • Hillman Cancer Center at University of Pittsburgh Cancer Institute
    Pittsburgh, Pennsylvania 15232, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 8, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00054522
Lead sponsor
Roswell Park Cancer Institute
First posted
Feb 6, 2003
Start date
Apr 2002
Primary completion
Jan 2006
Completion
Mar 2006
Last update
Mar 8, 2011

Study contacts

Donald L. Trump, MD
study chair · Roswell Park Cancer Institute

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2011. You cannot join it, but the record below documents what was studied.

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