Efficacy of FWGE in Combination With Hormone Therapy for the Treatment of Hormone-Refractory Prostate Cancer Patients

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 therapy, the gonadotropin releasing hormone (GnRH), which stopped being effective. The study will be conducted during two years with 60 patients. The efficacy will be assessed in terms of clinical and serological response and by specific questionnaires. This concept is based on previous reports regarding other diseases such as colon cancer, where the addition of a new drug to a drug which previously had failed, improved the patients’ survival, the quality of life and the clinical parameters. In addition, preclinical data have shown activity of that regimen in prostate cancer cell lines and in animals’ models.FWGE exhibits a wide variety of mode of actions, in a wide range of malignant tumors. It increased the natural immune responses while decreasing the systemic inflammation often present in cancer patients. It reduced the growth of human prostate tumor xenograft in mice and prolonged their survival. It delayed disease progression, increased overall survivals, improve quality of life and reduce oxidative stress.The long-term goal of this research is that the addition of FWGE to a drug which previously had failed, would slow down disease progression in patients with advanced and thus refractory cancers, improving the patients’ quality of life, their clinical parameters and survival.

Official Title

An Open Phase II Clinical Trial of Fermented Wheat Germ Extract in Combination With Hormone Therapy for the Treatment of Hormone-Refractory Prostate Cancer Patients.

Conditions

• Hormone Refractory Prostate Cancer

Study Type

Interventional

Study Design

Treatment, Non-Randomised, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study.

Further Details

Primary Outcome Measures:

• Response rate in 16 weeks.

Secondary Outcome Measures:

• Quality of life in 16 weeks

Study Start

JUne 2007

Eligibility & Criteria

• Ages Eligible for Study: 18 Years and older
• Genders Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age >18
• Histology/cytology diagnosis of prostate cancer
• Measurable disease as identified by tumor imaging (e.g. CT, MRI) or PSA values greater than 5 ng/ml, and rising in 3 consecutive measurements.
• Failure of 1st line hormone therapy (GnRH analogues)
• ECOG performance status 0-2

Exclusion Criteria:

• 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.

Total Enrolment

60

Contact Details

Nava Epstein, (PhD)
972-3-530-2997
nava.epstein@sheba.health.gov.il   

Rony Weitzen, (MD)
972-3-530-2997

Location: 

Oncology Division Sheba Medical Center 
Tel Hashomer, Ramat Gan
Israel, 52621