- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00596895
Isoflavone in Prostate-specific Antigen Recurrent Prostate Cancer
Phase II Trial of Isoflavone in Prostate-specific Antigen Recurrent Prostate Cancer After Previous Local Therapy.
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)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Florida
-
Jacksonville, Florida, United States, 32209
- University of Florida Shands
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Isoflavone treatment
|
Ingested 47 mg of isoflavone in three 8 oz servings per day
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Assess the effect of soy protein/isoflavones serum PSA levels in patients previously treated with radical prostatectomy and external beam radiation therapy.
Time Frame: Baseline, 3, 6, 9 and 12 months
|
Baseline, 3, 6, 9 and 12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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.
Time Frame: Baseline, 3, 6, 9 and 12 months
|
Baseline, 3, 6, 9 and 12 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Charles J. Rosser, MD, University of Florida
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UFJ2003-113
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Biochemical Recurrent Prostate Cancer
-
Matrix Biomed, Inc.Prostate Oncology SpecialistsNot yet recruitingProstate Cancer Recurrent | Biochemical Recurrent Prostate CancerUnited States
-
Azienda Ospedaliero-Universitaria CareggiRecruitingProstate Cancer | Prostate Adenocarcinoma | Prostate Cancer Recurrent | Biochemical Relapse Fo Malignant Neoplasm of ProstateItaly
-
National Cancer Institute (NCI)RecruitingBiochemical Recurrent Prostate CancerUnited States
-
National Cancer Institute (NCI)CompletedRecurrent Prostate Cancer | Stage I Prostate Cancer | Stage III Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI)CompletedRecurrent Prostate Cancer | Stage I Prostate Cancer | Stage III Prostate Cancer | Adenocarcinoma of the Prostate | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
-
National Cancer Institute (NCI)TerminatedRecurrent Prostate Cancer | Stage I Prostate Cancer | Adenocarcinoma of the Prostate | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
-
National Cancer Institute (NCI)TerminatedRecurrent Prostate Cancer | Stage III Prostate Cancer | Adenocarcinoma of the Prostate | Stage IV Prostate Cancer | Stage IIB Prostate CancerUnited States
-
Mayo ClinicNot yet recruitingRecurrent Prostate Cancer | Castration-resistant Prostate Cancer | Stage IVB Prostate Cancer AJCC v8 | Recurrent Castration-Sensitive Prostate CarcinomaUnited States
-
Centre for Probe Development and CommercializationMcDougall Scientific Ltd.CompletedRecurrent Prostate Cancer | Prostate Cancer RecurrentCanada
-
Mayo ClinicRecruitingBiochemically Recurrent Prostate Carcinoma | Stage IV Prostate Cancer AJCC v8 | Stage IIC Prostate Cancer AJCC v8 | Stage III Prostate Cancer AJCC v8 | Stage IIB Prostate Cancer AJCC v8 | Oligometastatic Prostate Carcinoma | Recurrent Prostate AdenocarcinomaUnited States
Clinical Trials on Isoflavone
-
Seoul National University HospitalCompletedAgeing | Photo-agingKorea, Republic of
-
University of East AngliaCompletedCardiovascular Disease Risk ReductionUnited Kingdom
-
National Nutrition and Food Technology InstituteCompleted
-
National Nutrition and Food Technology InstituteUnknownPeritoneal Dialysis PatientsIran, Islamic Republic of
-
National Cancer Institute (NCI)CompletedRecurrent Hypopharyngeal Squamous Cell Carcinoma | Recurrent Laryngeal Squamous Cell Carcinoma | Recurrent Oropharyngeal Squamous Cell Carcinoma | Recurrent Lip and Oral Cavity Squamous Cell Carcinoma | Recurrent Laryngeal Verrucous Carcinoma | Recurrent Oral Cavity Verrucous Carcinoma | Tongue... and other conditionsUnited States
-
National Health Research Institutes, TaiwanGenovate Biotechnology Co., Ltd.,; Taiwan Biotech Co., Ltd.Unknown
-
Federal University of UberlandiaCompleted
-
Johns Hopkins UniversityNational Cancer Institute (NCI); Physicians LaboratoriesCompleted
-
Federal University of UberlandiaCompleted
-
Beth Israel Deaconess Medical CenterNichimo - Tokyo, JapanCompleted