Prostate CancerPhase 2NCT00058266
Genistein in Treating Patients With Localized Prostate Cancer Who Are Planning to Undergo Radical Prostatectomy
A Phase 2 study testing genistein and conventional surgery in people with Prostate Cancer, run by Northwestern University at 5 sites in United States.
Trial summary
RATIONALE: Genistein may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. PURPOSE: Phase II trial to study the effectiveness of genistein in treating patients with localized prostate cancer who are planning to undergo radical prostatectomy. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- genistein and conventional surgery
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 5 sitesUnited States
- Study dates
- Dec 2002to Sep 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Diagnosis of localized prostate cancer
- Diagnosed within the past 6 months
- T1 or T2 disease
- Gleason score 5-8
- Prostate-specific antigen no greater than 20 ng/mL
- Radical prostatectomy planned
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-1
Life expectancy
- More than 2 years
Hematopoietic
- Hemoglobin greater than 9.0 g/dL
- Platelet count greater than 100,000/mm^3
- Absolute neutrophil count greater than 1,000/mm^3
Hepatic
- SGPT and SGOT less than 3 times normal
- Bilirubin less than 3 mg/dL (less than 1.5 times normal) (patients with an elevated bilirubin due to a familial defect in bilirubin metabolism will be considered on an individual basis)
Renal
- Creatinine less than 2.0 mg/dL
Cardiovascular
- No venous thrombosis within the past year
Other
- Patients must use effective barrier contraception
- No other medical condition that would preclude study therapy
- No known soy intolerance
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- No concurrent hormonal therapy for prostate cancer
Radiotherapy
- Not specified
Surgery
- See Disease Characteristics
Other
- No concurrent soy supplements
- No concurrent foods high in genistein
- No concurrent active therapy for neoplastic disorders
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, 60611-3013
Veterans Affairs Medical Center - Lakeside Chicago
Chicago, Illinois, 60611
Evanston Northwestern Healthcare - Evanston Hospital
Evanston, Illinois, 60201-1781
Ingalls Cancer Care Center at Ingalls Memorial Hospital
Harvey, Illinois, 60426
University of Washington School of Medicine
Seattle, Washington, 98195
About this study
Official title: A Phase II Study Of Genistein In Patients With Localized Prostate Cancer (Molecular Correlates of Soy In Humans)
RATIONALE: Genistein may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth.
PURPOSE: Phase II trial to study the effectiveness of genistein in treating patients with localized prostate cancer who are planning to undergo radical prostatectomy.
Read the detailed description
OBJECTIVES:
- Determine the toxicity of genistein in patients with localized prostate cancer treated with radical prostatectomy.
- Determine the decrease, if any, of prostate-specific antigen-positive cells in the operative field of patients treated with this drug.
- Determine the quality of life of patients treated with this drug.
OUTLINE: Patients receive 1 of 2 treatment regimens.
- Group A: Patients receive oral genistein once daily for 1-2 months, undergo radical prostatectomy, and then continue oral genistein once daily for 1-2 months afterward (for a total of 3 months of therapy).
- Group B: Patients undergo radical prostatectomy. Beginning 1 month after surgery, patients receive genistein as in arm I for 3 months.
Quality of life is assessed at baseline and at 1 and 3 months after surgery.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 88 patients (44 patients per treatment group) will be accrued for this study within 2 years.
- Conditions
- Prostate Cancer
- Being tested
- genistein, conventional surgery
- Keywords
- stage I prostate cancer, stage II prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
genisteinDietary supplement
Given orally
conventional surgeryProcedure or surgery
Patients undergo surgery
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Patients receive oral genistein once daily for 1-2 months, undergo radical prostatectomy, and then continue oral genistein once daily for 1-2 months afterward (for a total of 3 months of therapy). Receives: Dietary Supplement: genistein; Procedure: conventional surgery |
| Group B | Experimental | Patients undergo radical prostatectomy. Beginning 1 month after surgery, patients receive genistein as in arm I for 3 months. Receives: Dietary Supplement: genistein; Procedure: conventional surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Toxicity
Measured: At surgery & monthly thereafter during treatment (3 mos)
Decrease in prostate-specific antigen-positive cells
Measured: At time of surgery
Alteration in cell morphology
Measured: At time of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2003 (estimated)
- Study startDec 2002
- Primary completionNov 2006
- Study completionSep 2009
Why it stopped: Data Monitoring Committee cited poor accrual.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Raymond C. Bergan, MD, Study chair, Robert H. Lurie Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00058266
- Sponsor's protocol ID
- NU 00U7
- Other IDs
- NU-00U7
- Status last verified
- Jul 2012
- First submitted
- 7 Apr 2003
- Last updated
- 19 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study Of Genistein In Patients With Localized Prostate Cancer (Molecular Correlates of Soy In Humans)
- ClinicalTrials.gov ID
- NCT00058266
- Acronym / sponsor ID
- NU 00U7
- Conditions
- Prostate Cancer
- Keywords
- stage I prostate cancer, stage II prostate cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Data Monitoring Committee cited poor accrual.
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Dec 2002
- Primary completion
- Nov 2006 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 9 Apr 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Genistein may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth.
PURPOSE: Phase II trial to study the effectiveness of genistein in treating patients with localized prostate cancer who are planning to undergo radical prostatectomy.
Detailed description
OBJECTIVES:
- Determine the toxicity of genistein in patients with localized prostate cancer treated with radical prostatectomy.
- Determine the decrease, if any, of prostate-specific antigen-positive cells in the operative field of patients treated with this drug.
- Determine the quality of life of patients treated with this drug.
OUTLINE: Patients receive 1 of 2 treatment regimens.
- Group A: Patients receive oral genistein once daily for 1-2 months, undergo radical prostatectomy, and then continue oral genistein once daily for 1-2 months afterward (for a total of 3 months of therapy).
- Group B: Patients undergo radical prostatectomy. Beginning 1 month after surgery, patients receive genistein as in arm I for 3 months.
Quality of life is assessed at baseline and at 1 and 3 months after surgery.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 88 patients (44 patients per treatment group) will be accrued for this study within 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Dietary Supplement: genistein, Procedure: conventional surgeryPatients receive oral genistein once daily for 1-2 months, undergo radical prostatectomy, and then continue oral genistein once daily for 1-2 months afterward (for a total of 3 months of therapy). |
| Group B | Experimental | Dietary Supplement: genistein, Procedure: conventional surgeryPatients undergo radical prostatectomy. Beginning 1 month after surgery, patients receive genistein as in arm I for 3 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| genisteinGiven orally | Dietary supplement | Group A, Group B |
| conventional surgeryPatients undergo surgery | Procedure or surgery | Group A, Group B |
Primary outcome
Toxicity
Time frame: At surgery & monthly thereafter during treatment (3 mos)
Decrease in prostate-specific antigen-positive cells
Time frame: At time of surgery
Alteration in cell morphology
Time frame: At time of surgery
Results and safety
The study was stopped early (reason given: Data Monitoring Committee cited poor accrual.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raymond C. Bergan, MD study chair
Robert H. Lurie Cancer Center
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing genistein and conventional surgery in people with Prostate Cancer, run by Northwestern University at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Data Monitoring Committee cited poor accrual.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Toxicity (time frame: At surgery & monthly thereafter during treatment (3 mos)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2012.