Isoflavone in Prostate-specific Antigen Recurrent Prostate Cancer
Phase II Trial of Isoflavone in Prostate-specific Antigen Recurrent Prostate Cancer After Previous Local Therapy.
1 other identifier
interventional
20
1 country
1
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Nov 2003
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2007
CompletedFirst Submitted
Initial submission to the registry
January 8, 2008
CompletedFirst Posted
Study publicly available on registry
January 17, 2008
CompletedSeptember 20, 2011
January 1, 2008
4 years
January 8, 2008
September 16, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
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
Study Arms (1)
1
EXPERIMENTALIsoflavone treatment
Interventions
Ingested 47 mg of isoflavone in three 8 oz servings per day
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Florida Shands
Jacksonville, Florida, 32209, United States
Related Publications (1)
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.
PMID: 18471323DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Charles J. Rosser, MD
University of Florida
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 8, 2008
First Posted
January 17, 2008
Study Start
November 1, 2003
Primary Completion
November 1, 2007
Study Completion
November 1, 2007
Last Updated
September 20, 2011
Record last verified: 2008-01