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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2009 by Sheba Medical Center.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00411853
First Posted: December 15, 2006
Last Update Posted: July 31, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Sheba Medical Center
  Purpose

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.


Condition Intervention Phase
Hormone Refractory Prostate Cancer Drug: Fermented Wheat germ extract Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • Response rate in 16 weeks. [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • Quality of life in 16 weeks [ Time Frame: 1 year ]

Estimated Enrollment: 60
Study Start Date: June 2007
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Fermented Wheat germ extract
    Fermented Wheat Germ powder, given orally, per os, 17 gram daily
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Subject Inclusion Criteria:

  1. Age >18
  2. Histology/cytology diagnosis of prostate cancer
  3. 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.
  4. failure of 1st line hormone therapy (GnRH analogues)
  5. ECOG performance status 0-2

Subject Exclusion Criteria:

  1. Concurrent use of systemic anti-neoplastic therapy
  2. Patients who had received systemic chemotherapy for prostate cancer.
  3. Patients receiving an investigational agent within the past 30 days of study entry.
  4. Patients with evidence of circumstances that are likely to interfere with the absorption of orally administrated products.
  5. 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)
  6. ECOG performance status > 2
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00411853


Contacts
Contact: Nava Epstein, PhD 972-3-530-2997 nava.epstein@sheba.health.gov.il
Contact: Rony Weitzen, MD 972-3-530-2997

Locations
Israel
Oncology Division Sheba Medical Center Recruiting
Tel Hashomer, Ramat Gan, Israel, 52621
Contact: Rony Weitzen, MD         
Sponsors and Collaborators
Sheba Medical Center
Investigators
Principal Investigator: Rony Weitzen, MD Oncology Division Sheba Medical Center
  More Information

Responsible Party: Dr. Rony Weitzen, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT00411853     History of Changes
Other Study ID Numbers: SHEBA-06-4232-RW-CTIL
First Submitted: December 14, 2006
First Posted: December 15, 2006
Last Update Posted: July 31, 2009
Last Verified: July 2009

Keywords provided by Sheba Medical Center:
Prostate, Hormone Refractory, Cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs