Official Title: “Calcitriol + Dexamethasone in Early, Recurrent Prostate Cancer Following Local Therapy, A Phase I/II Trial”

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.

Study Type: Interventional

Study Design: Treatment, Open Label

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.

Intervention(s) in this Clinical Trial

• Drug: calcitriol
• Drug: dexamethasone

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

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Roswell Park Cancer Institute

Overall Clinical Trial Officials and Contacts

Donald L. Trump, MD Study Chair Roswell Park Cancer Institute  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00054522

Study ID Number: CDR0000270758

ClinicalTrials.gov Identifier: NCT00054522

Health Authority: United States: Federal Government

Clinical trial summary from the National Cancer Institute's PDQ® database