Isoflavone in Prostate-specific Antigen Recurrent Prostate Cancer

University of Florida

Status and phase

Completed

Phase 2

Conditions

Biochemical Recurrent Prostate Cancer

Treatments

Dietary Supplement: Isoflavone

Study type

Interventional

Funder types

Other

Identifiers

NCT00596895

UFJ2003-113

Details and patient eligibility

About

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)

Full 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.

Enrollment

20 patients

Sex

Male

Ages

45 to 80 years old

Volunteers

No Healthy Volunteers

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.