Isoflavone in Prostate-specific Antigen Recurrent Prostate Cancer

Biochemical Recurrent Prostate Cancer Clinical Trial

Official title:

Phase II Trial of Isoflavone in Prostate-specific Antigen Recurrent Prostate Cancer After Previous Local Therapy.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00596895
• Other study ID #: UFJ2003-113
• Status: Completed
• Phase: Phase 2
• First received: January 8, 2008
• Last updated: September 16, 2011
• Start date: November 2003
• Est. completion date: November 2007

Study information

• Verified date: January 2008
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 45 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Biochemical Recurrent Prostate Cancer
• Prostatic Neoplasms

Intervention

Dietary Supplement:
• Isoflavone
Ingested 47 mg of isoflavone in three 8 oz servings per day

Locations

Country	Name	City	State
United States	University of Florida Shands	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess the effect of soy protein/isoflavones serum PSA levels in patients previously treated with radical prostatectomy and external beam radiation therapy.		Baseline, 3, 6, 9 and 12 months	No
Secondary	Assess the effect of soy protein/isoflavones on serum testosterone, isoflavone metabolites, and cholesterol. Assess the effect of soy protein/isoflavones on quality of life of these patients.		Baseline, 3, 6, 9 and 12 months	No