Status:
UNKNOWN
Efficacy of FWGE in Combination With Hormone Therapy for the Treatment of Hormone-Refractory Prostate Cancer Patients
Lead Sponsor:
Sheba Medical Center
Conditions:
Hormone Refractory Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
We propose in this study to treat hormone refractory prostate cancer (HRPC) patients., with a novel preparation of fermented wheat germ nutriment (FWGE), in combination with the 1st line hormone thera...
Detailed Description
Background and Significance 1. The challenge: Prostate cancer is a major worldwide health problem and is the most frequently diagnosed malignancy in men today. In the United States prostate cance...
Eligibility Criteria
Inclusion
- Subject
- Age \>18
- Histology/cytology diagnosis of prostate cancer
- Measurable disease as identified by tumor imaging (e.g. CT, MRI) or PSA values greater than 1.5 ng/ml, and rising in 3 consecutive measurements.
- failure of 1st line hormone therapy (GnRH analogues)
- ECOG performance status 0-2
- Subject
Exclusion
- Concurrent use of systemic anti-neoplastic therapy
- Patients who had received systemic chemotherapy for prostate cancer.
- Patients receiving an investigational agent within the past 30 days of study entry.
- Patients with evidence of circumstances that are likely to interfere with the absorption of orally administrated products.
- patients with co-morbidities considered to potentially influence the outcome of treatment in the judgment of the investigator (life-threatening diseases such as heart failure)
- ECOG performance status \> 2
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2012
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00411853
Start Date
June 1 2007
End Date
June 1 2012
Last Update
July 31 2009
Active Locations (1)
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1
Oncology Division Sheba Medical Center
Tel Litwinsky, Ramat Gan, Israel, 52621