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Clinical Trials
Pre-Clinical / Laboratory Research
Center
for Holistic Urology
Atchley Pavilion 11th Floor
161 Ft. Washington Ave.
New York, NY 10032
Map
/ Directions
info@holisticurology.com
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Clinical Trials
- POM
POM
- This trial is currently OPEN. For
more information call Dr. Espinosa at 212-305-3790 or e-mail him at
ge2108@columbia.edu
Pomegranate
juice has been shown to be a rich source of polyphenolic flavonoids
- the deeply pigmented antioxidants in many fruits and vegetable - which
has shown to lower risks of malignancies including prostate cancer.
Because the blood-red juice of pomegranates is especially rich in such
compounds we are one of four centers testing it against metastatic prostate
cancer. These are malignancies that have spread beyond the gland, which
in these men had been removed or destroyed, along with tumors, by radiation.
Over time, the presence of these residual cancer cells was confirmed
by rising concentrations of a protein in the men's blood: prostate-specific
antigen (PSA). Because PSA is made by prostate cells-usually cancerous
ones-and because these men no longer had intact prostates, the presence
of the substance indicated that cancerous prostate cells continued to
exist in the men's' bodies, Pantuck explains.
Study
Purpose: To compare the effects of daily consumption of pomegranate
juice, pomegranate liquid extract and placebo in men with rising PSA
levels after primary therapy for localized prostate cancer.
Eligibility:
A total of 250 patients will be recruited ages 18 Years and above.
DISEASE
CHARACTERISTICS:
- Histologically
confirmed adenocarcinoma of the prostate
- Must have
completed prior surgery, cryotherapy, or radiotherapy for the primary
tumor
- Documented
rising prostate-specific antigen (PSA)
- Absolute
level of PSA > 0.2 ng/mL after surgery
- Absolute
level of PSA > 1.0 ng/mL after radiation or cryotherapy
- Absolute
level of PSA = 0.4 ng/mL after multiple treatment modalities (e.g.,
surgery with radiotherapy or radiotherapy with cryotherapy)
- PSA must
be = 100% above best nadir achieved
- PSA doubling
time > 3 months or = 24 months
- Patients
must have = 3 rising PSA time points above the minimum nadir achieved
over = 6 months
- The interval
between PSA time points must be > 2 weeks
- PSA =
7.0 ng/mL
- Patients
who underwent radical prostatectomy and never achieved undetectable
serum PSA after surgery are not eligible
- Gleason
score = 7
- No histologically
positive lymph nodes
- No evidence
of metastatic disease by physical examination, CT scan, or bone scan
PATIENT
CHARACTERISTICS:
- Life expectancy
= 6 months
- "
ECOG performance status 0 or 1
- No significant
concomitant medical or psychiatric conditions that would limit study
compliance
- No known
allergies to pomegranate juice
- No known
diabetes with hemoglobin A
- level
> 7.0% in the past 3 months
- Diabetic
patients entering study who have not had hemoglobin A_1c level measured
in the past 3 months must have levels measured at study initiation
- No clinically
abnormal laboratory values > 2 times the upper limit of normal
PRIOR
CONCURRENT THERAPY:
- More
than 4 weeks since prior and no concurrent experimental drugs, high-dose
steroids, or other cancer treatment
- No hormonal
therapy, with the exception of neoadjuvant androgen-deprivation therapy
(ADT), prior to or concurrent with primary therapy
- Patients
who received prior neoadjuvant ADT must have serum testosterone >
150 ng/dL
- No prior
or concurrent hormonal therapy for rising PSA after primary therapy
for prostate cancer
- No finasteride
or dutasteride at any time point after primary therapy and during study
therapy
- No other
concurrent commercial pomegranate products
- No other
concurrent systemic or local therapy for prostate cancer
- Concurrent
dietary/herbal supplements (e.g., saw palmetto or selenium) allowed
provided dose has been stable for = 2 months prior to study entry and
there are no plans to change or stop the supplements during study therapy.
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