Clinical trial NCT00596895: Isoflavone in Prostate-specific Antigen Recurrent Prostate Cancer
Official title: Phase II Trial of Isoflavone in Prostate-specific Antigen Recurrent Prostate Cancer After Previous Local Therapy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Biochemical Recurrent Prostate Cancer
Keywords: Isoflavone, PSA, prostate cancer, recurrent, quality of life
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2008-01-17
Enrollment: 20
Sex: MALE
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Assess the effect of soy protein/isoflavones serum PSA levels in patients previously treated with radical prostatectomy and external beam radiation therapy.
timeFrame: Baseline, 3, 6, 9 and 12 months
Secondary outcomes:
measure: 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.
timeFrame: Baseline, 3, 6, 9 and 12 months
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: University of Florida Shands
state: Florida
Study officials:
affiliation: University of Florida
name: Charles J. Rosser, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.