Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	18 and over	NCI	RPCI-RP-0203 PCI-00-034, NCT00054522

Objectives

1. 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.
2. Determine the safety of this regimen in these patients.
3. Determine the utility of serum PSA in monitoring the therapeutic effect of calcitriol in these patients.

Entry 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

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

Patient Characteristics:

Age

• 18 and over

Performance status

• ECOG 0-1

Life expectancy

• At least 12 months

Hematopoietic

• Platelet count at least 100,000/mm³
• 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

Expected Enrollment

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

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.

Trial Contact Information

Trial Lead Organizations

Roswell Park Cancer Institute

Donald Trump, MD, Protocol chair		Ph: 716-845-3499; 800-685-6825 Email: donald.trump@roswellpark.org

Registry Information
Official Title		Calcitriol + Dexamethasone in Early, Recurrent Prostate Cancer Following Local Therapy, A Phase I/II Trial
Trial Start Date		2002-04-18
Registered in ClinicalTrials.gov		NCT00054522
Date Submitted to PDQ		2003-01-07
Information Last Verified		2005-02-09
NCI Grant/Contract Number		P30-CA16056

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