A new phase II clinical trial in prostate cancer is being
conducted by Dr. Charles E. Myers, Jr.
A new phase II clinical trial in prostate cancer is being
conducted by Dr.Charles E. Myers, Jr. through the Foundation
for Cancer Education and Research in Earlysville, VA. New
patients are currently being recruited for:
The Treatment of Slow-Growing Recurrent Prostate Cancer
With Vitamin D3 Protocol Version Date: 1/25/08
Inclusion Criteria
Diagnosis of prostate cancer
At relapse after radical prostatectomy, radiation therapy,
or both and PSA doubling time of 9 or more months
PSA at entry must be less than 15 ng/ml
No evidence of metastatic prostate cancer by CT or bone
scan
Subject must be assessed by the investigator as likely to
be able to adhere to the protocol
Exclusion Criteria
Hormone or chemotherapy or other systemic therapy
Abnormal creatinine
Abnormal serum or urine calcium
History of renal calculi
Presence of other medical disease likely to limit survival
to less than 5 years
Diagnosis of celiac disease or other causes of fat malabsorption.
Known abnormalities in calcium metabolism, such as hyper-
and hypoparathyroidism
Restrictions on use of other drugs or treatments
No other prostate cancer treatment may be used
No other drugs or supplements reported to slow PSA doubling
times
The patient cannot institute any treatments listed in Table
1 during the treatment period
Treatment
Aim to adjust the oral dose of vitamin D3 to maintain serum
25-hydroxyvitamin D3 levels in the high end of the normal
range: between 60-100ng/ml
Subjects will have PSA, testosterone, dihydrotestosterone,
calcidiol, calcitriol, fasting serum parathyroid hormone, serum calcium,
serum phosphate, urine calcium/creatinine ratio, BUN and creatinine
measured monthly for the first six months. During the second six months,
these measurements will be done every 2 months. After the first
12 months, these tests will be performed every 3 months as long as they remain
on study.
Trial Contact Information: Joanne Mahanes, Director of Clinical
Research,
via email at jm.fcre@earthlink.net
or by calling 434-220-4539.
