Isoflavone in Prostate-specific Antigen Recurrent Prostate Cancer

NCT ID: NCT00596895

Last Updated: 2011-09-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-11-30
• Study Completion Date: 2007-11-30

Brief Summary

Primary Outcome Measures:

Decrease in rate of serum PSA rise

Secondary Outcome Measures:

Adherence to treatment regimens

Quality of life as assessed by FACT-P at baseline and at 12 months of treatment

Modulation of serum testosterone,isoflavone metabolites, and cholesterol

Estimated Enrollment: 27 Study Start Date: November 2003 Estimated Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)

Detailed Description

• Pretreatment evaluation included a complete medical history, physical examination (including digital rectal examination), serum PSA, free/total testosterone, lipids, serum isoflavone levels (genistein, daidzein, and equol), and assessment of quality of life (Functional Assessment of Cancer Treatment-Prostate, FACT-P questionnaire).
• Whole blood will be obtained prior to initiation of the study to assess for DNA polymorphism.
• Follow-up serum PSA levels to assess efficacy were obtained at 3, 6, 9, and 12 months after initiation of treatment.
• Medical history, physical examination, serum testosterone, lipids, isoflavone, and quality of life were assessed at 6 and 12 months after initiation of treatment.

Conditions

Biochemical Recurrent Prostate Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Isoflavone treatment

Group Type: EXPERIMENTAL

Isoflavone

Intervention Type: DIETARY_SUPPLEMENT

Ingested 47 mg of isoflavone in three 8 oz servings per day

Interventions

Isoflavone

Ingested 47 mg of isoflavone in three 8 oz servings per day

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Soy Dream Enriched, Original or Vanilla, soy milk

Eligibility Criteria

Inclusion Criteria

• Raising serum PSA profile after previous definitive therapy (e.g., radical prostatectomy or external beam radiation therapy).
• Life expectancy of at least one year and performance status of <2 of Zubrod scale.

Exclusion Criteria

• Metastatic or locally recurrent disease demonstrated on bone scan, computed tomography or transrectal ultrasound, or be clinically symptomatic at the time of enrollment
• No androgen deprivation therapy (ADT) or chemotherapy within 12 months of entry into the study.
• Known allergic reaction to milk or soy products were excluded.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Charles J. Rosser, MD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

University of Florida Shands

Jacksonville, Florida, United States

Countries

United States

References

Pendleton JM, Tan WW, Anai S, Chang M, Hou W, Shiverick KT, Rosser CJ. Phase II trial of isoflavone in prostate-specific antigen recurrent prostate cancer after previous local therapy. BMC Cancer. 2008 May 11;8:132. doi: 10.1186/1471-2407-8-132.

Reference Type: DERIVED

PMID: 18471323 (View on PubMed)

Other Identifiers

UFJ2003-113

Identifier Type: -

Identifier Source: org_study_id