Prostabel
- This trial is currently CLOSED.
For more information call Dr. Espinosa at 212-305-3790 or e-mail him
at ge2108@columbia.edu
Study
Purpose: This is a phase I study to determine the safety and toxicity
profile of Prostabel® when administered in human subjects with an
elevated prostate-specific antigen (PSA) and a negative prostate biopsy.
Study
subjects and method of recruitment: This study will enroll a maximum
of 42 male subjects between 40-75 years of age who have a PSA =2.5ng/dL
and have had a negative prostate biopsy within the past 6 months.
These subjects will be in otherwise good health, and have no other life
threatening diseases.
All
eligible subjects referred to or being treated at the Department of
Urology will be offered participation in this study.
Study
procedures: Prior to study participation, all subjects will sign
an informed consent. Successive cohorts of three patients will be placed
on successive nutritional supplement regimens as follows, with the exception
of six patients placed on the last regimen:
All subjects
will initially be seen in the clinic for enrollment and baseline assessment.
All subjects will then return to the clinic at 1, 3, 6, 9, and 12 months
from study enrollment for follow-up visits. At each visit, the patient
will complete height and weight measurements. The following blood and
urine tests will be performed at the initial enrollment visit and at
the 1, 3, 6, 9, and 12 month follow-up visits (30 cc blood sample at
each visit for a total of 180 cc throughout the study and a voided urine
sample at each visit):
PSA (prostate specific antigen)
Basic Metabolic Panel
Complete Blood Count (CBC)
Hepatic Function Panel
Coagulation Panel
Urinanalysis
At baseline and also at the 6- and 12-month visits, the patient will
complete a 2 questionnaires: the American Urological Association's (AUA)
Symptom Score Questionnaire and the RAND 12-Item Health Survey/UCLA
Prostate Cancer Short Form; these standard surveys will enable us to
further evaluate any symptomatic benefit or discomfort that these extracts
may have on the subject.
Within
one month of completing the study, the subjects will have a prostate
biopsy to assess for histologic change from the initial biopsy.
All subjects
will remain in the study for the 12-month duration unless they are non-compliant
with study procedures or if the principal investigator feels that it
is not in their best interest to remain in the study.
