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