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


Phase 2
45 Years
80 Years
Not Enrolling
Male
Biochemical Recurrent Prostate Cancer

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Trial Information

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


- 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.


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Assess the effect of soy protein/isoflavones serum PSA levels in patients previously treated with radical prostatectomy and external beam radiation therapy.

Outcome Time Frame:

Baseline, 3, 6, 9 and 12 months

Safety Issue:

No

Principal Investigator

Charles J. Rosser, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Florida

Authority:

United States: Institutional Review Board

Study ID:

UFJ2003-113

NCT ID:

NCT00596895

Start Date:

November 2003

Completion Date:

November 2007

Related Keywords:

  • Biochemical Recurrent Prostate Cancer
  • Isoflavone, PSA, prostate cancer, recurrent, quality of life
  • Prostatic Neoplasms

Name

Location
University of Florida Shands Jacksonville, Florida  32209