NCT00411853

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 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jun 2007

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 14, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 15, 2006

Completed
6 months until next milestone

Study Start

First participant enrolled

June 1, 2007

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

July 31, 2009

Status Verified

July 1, 2009

Enrollment Period

4 years

First QC Date

December 14, 2006

Last Update Submit

July 30, 2009

Conditions

Hormone Refractory Prostate Cancer

Keywords

Prostate, Hormone Refractory, Cancer

Outcome Measures

Primary Outcomes (1)

  • Response rate in 16 weeks.

    1 year

Secondary Outcomes (1)

  • Quality of life in 16 weeks

    1 year

Interventions

Fermented Wheat germ extractDRUG

Fermented Wheat Germ powder, given orally, per os, 17 gram daily

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oncology Division Sheba Medical Center

Tel Litwinsky, Ramat Gan, 52621, Israel

RECRUITING

Related Publications (1)

  • Weitzen R, Epstein N, Oberman B, Shevetz R, Hidvegi M, Berger R. Fermented Wheat Germ Extract (FWGE) as a Treatment Additive for Castration-Resistant Prostate Cancer: A Pilot Clinical Trial. Nutr Cancer. 2022;74(4):1338-1346. doi: 10.1080/01635581.2021.1952457. Epub 2021 Jul 21.

    PMID: 34286638DERIVED

MeSH Terms

Conditions

Neoplasms

Interventions

Avemar

Study Officials

  • Rony Weitzen, MD

    Oncology Division Sheba Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nava Epstein, PhD

CONTACT

972-3-530-2997nava.epstein@sheba.health.gov.il

Rony Weitzen, MD

CONTACT

972-3-530-2997

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

December 14, 2006

First Posted

December 15, 2006

Study Start

June 1, 2007

Primary Completion

June 1, 2011

Study Completion

June 1, 2012

Last Updated

July 31, 2009

Record last verified: 2009-07

Locations

IL(1)