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Calcitriol + Dexamethasone in Early, Recurrent Prostate Cancer Following Local Therapy, A Phase I/II Trial

Phase 2
18 Years
Not Enrolling
Prostate Cancer

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Trial Information

Calcitriol + Dexamethasone in Early, Recurrent Prostate Cancer Following Local Therapy, A Phase I/II Trial


- 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

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.

Inclusion Criteria


- Histologically confirmed adenocarcinoma of the prostate meeting all of the following

- 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

- 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

- 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

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Donald L. Trump, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Roswell Park Cancer Institute


United States: Food and Drug Administration

Study ID:




Start Date:

April 2002

Completion Date:

March 2006

Related Keywords:

  • Prostate Cancer
  • adenocarcinoma of the prostate
  • recurrent prostate cancer
  • Prostatic Neoplasms



Roswell Park Cancer Institute Buffalo, New York  14263
Hillman Cancer Center at University of Pittsburgh Cancer Institute Pittsburgh, Pennsylvania  15236