Adenocarcinoma of the ProstatePhase 2NCT01126879
Genistein in Treating Patients With Prostate Cancer
A Phase 2 study testing genistein and therapeutic conventional surgery in people with Adenocarcinoma of the Prostate and Recurrent Prostate Cancer, run by Northwestern University at 1 site in United States.
Trial summary
RATIONALE: Genistein may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This randomized phase II trial is studying how well genistein works in treating patients with prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Adenocarcinoma of the Prostate, Recurrent Prostate Cancer, Stage I Prostate Cancer
- What is being tested?
- genistein and therapeutic conventional surgery
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Feb 2011to 28 Dec 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Participants must have a pathologic diagnosis of prostate cancer within the past 6 months, have clinical stage T1-3 disease, PSA >= 10, Gleason score >= 8, and have elected to undergo radical prostatectomy; those found to have detectable circulating prostate cancer cells in the blood as detected by qRT-PCR for PSA will be eligible to proceed onto the treatment phase of the protocol; pathology slides used for diagnosis will be submitted to the SPORE tissue pathology core for review
- ECOG performance status 0-1
- Hemoglobin > 9.0gm/dl
- Platelets >= 100 K/uL
- ANC > 1000/uL
- AST (SGOT)/ALT (SGPT) < 3X upper limit of normal
Show all 11Show fewer
- Creatinine < 2.0 mg/dl
- Total bilirubin < 2 mg/dl (Note: Subjects with a higher level of bilirubin due to a familial defect in bilirubin metabolism will be considered on an individual basis)
- Participants must agree not to take soy supplements
- Ability to understand and the willingness to sign a written informed consent document
- Willingness to take study agent for at least 2 weeks prior to radical prostatectomy
Who cannot join
- History of venous thrombosis within past year
- Participants must not be receiving active therapy for neoplastic disorders (including hormone or radiation therapy for prostate cancer)
- Participants may not be receiving any other investigational agents
- Known soy intolerance
- Medical conditions that, in the opinion of the investigators, would jeopardize either the patient or the integrity of the data obtained
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 2 Trial of Genistein in Men With Circulating Prostate Cancer Cells
RATIONALE: Genistein may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This randomized phase II trial is studying how well genistein works in treating patients with prostate cancer.
Read the detailed description
PRIMARY OBJECTIVES:
- Determine whether genistein treatment will decrease the number of circulating prostate cells (CPCs) in the peripheral blood as measured by qRT-PCR for PSA performed on RNA extracted from peripheral blood mononuclear cells (PBMNCs).
SECONDARY OBJECTIVES:
- Determine the natural history of circulating prostate cells (CPCs) in a cohort of subjects prior to and post radical prostatectomy.
II. Compare the measurement of PSA between three separate methods: in CPCs by qRT-PCR, in serum by the standard clinical chemistry assay (i.e., ELISA), and in plasma and serum by the nano-PSA assay.
III. Measure the effect of genistein on gene and protein expression in prostate tissue by qRT-PCR and immunohistochemistry, respectively, for the following genes and their respective protein products: HSP27, MMP-2, ALK-2, BASP1, and HCF2.
OUTLINE:
Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive oral genistein once daily for 3 months beginning at least 1 month prior to radical prostatectomy.
ARM II: Patients receive oral placebo once daily for 3 months beginning at least 1 month prior to radical prostatectomy.
All patients undergo radical prostatectomy at least 2 weeks, but not more than 3 months following the start of therapy.
After completion of study treatment, patients are followed at 1, 6, and 12 months.
- Conditions
- Adenocarcinoma of the Prostate, Recurrent Prostate Cancer, Stage I Prostate Cancer, Stage II Prostate Cancer, Stage III Prostate Cancer
- Being tested
- genistein, placebo, therapeutic conventional surgery
- 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
Also called CI 75610, Genestein, genisteol, genisterin
Given orally
placeboOther
Also called PLCB
Given orally
therapeutic conventional surgeryProcedure or surgery
Radical prostatectomy for treatment of prostate cancer
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | Patients receive oral genistein once daily for 3 months beginning at least 1 month prior to radical prostatectomy. Receives: Dietary Supplement: genistein; Procedure: therapeutic conventional surgery |
| Arm II | Placebo comparator | Patients receive an oral placebo once daily for 3 months beginning at least 1 month prior to radical prostatectomy. Receives: Other: placebo; Procedure: therapeutic conventional surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Circulating Prostate Cells (CPCs) in the Blood as Determined by qRT-PCR for PSA on RNA Extracted From PBMNCs
Blood will be collected to analyze the number of CPC's at screening, after 1-month of treatment, at surgery and at 1 and 12 months after surgery.
Measured: At screening, after 1-month of treatment, at surgery and at 1 and 12 months after surgery
Secondary outcomes (3)
Natural History of Circulating Prostate Cells (CPCs) in a Cohort of Subjects Prior to and Post Radical Prostatectomy
Blood will be drawn to analyze the natural history of circulating prostate cells (CPCs) in a cohort of subjects at baseline and 1 and 12 months after surgery.
Measured: At baseline, 1 and 12 months after surgery
Measure the Effect of Genistein on Select Gene and Protein Expressions in Prostate Tissue
At baseline and time of surgery, tissue will be collected to measure the effect of genistein on select gene and protein expressions in prostate tissue.
Measured: At baseline and at time of surgery
Measurement of PSA in Serum and Plasma by Nanotechnology
Blood will be collected to measure PSA in serum and plasma by nanotechnology at screening, after 1-month of treatment, at surgery and at 1 and 12 months after surgery.
Measured: At screening, after 1-month of treatment, at surgery and at 1 and 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2010 (estimated)
- Study start3 Feb 2011
- Primary completion9 May 2013
- Study completion28 Dec 2013
Why it stopped: Closed due to low accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Adenocarcinoma of the ProstateStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- William Catalona, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01126879
- Sponsor's protocol ID
- NCI 09U2
- Other IDs
- NCI-2010-00941, STU00019487, P50CA090386
- Status last verified
- Apr 2019
- First submitted
- 18 May 2010
- Last updated
- 10 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Trial of Genistein in Men With Circulating Prostate Cancer Cells
- ClinicalTrials.gov ID
- NCT01126879
- Acronym / sponsor ID
- NCI 09U2
- Conditions
- Adenocarcinoma of the Prostate, Recurrent Prostate Cancer, Stage I Prostate Cancer, Stage II Prostate Cancer, Stage III Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Closed due to low accrual
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 3 Feb 2011 (actual)
- Primary completion
- 9 May 2013 (actual)
- Study completion
- 28 Dec 2013 (actual)
- First posted
- 20 May 2010 (estimated)
- Results
- Posted 2 Jul 2019
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 tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This randomized phase II trial is studying how well genistein works in treating patients with prostate cancer.
Detailed description
PRIMARY OBJECTIVES:
- Determine whether genistein treatment will decrease the number of circulating prostate cells (CPCs) in the peripheral blood as measured by qRT-PCR for PSA performed on RNA extracted from peripheral blood mononuclear cells (PBMNCs).
SECONDARY OBJECTIVES:
- Determine the natural history of circulating prostate cells (CPCs) in a cohort of subjects prior to and post radical prostatectomy.
II. Compare the measurement of PSA between three separate methods: in CPCs by qRT-PCR, in serum by the standard clinical chemistry assay (i.e., ELISA), and in plasma and serum by the nano-PSA assay.
III. Measure the effect of genistein on gene and protein expression in prostate tissue by qRT-PCR and immunohistochemistry, respectively, for the following genes and their respective protein products: HSP27, MMP-2, ALK-2, BASP1, and HCF2.
OUTLINE:
Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive oral genistein once daily for 3 months beginning at least 1 month prior to radical prostatectomy.
ARM II: Patients receive oral placebo once daily for 3 months beginning at least 1 month prior to radical prostatectomy.
All patients undergo radical prostatectomy at least 2 weeks, but not more than 3 months following the start of therapy.
After completion of study treatment, patients are followed at 1, 6, and 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Dietary Supplement: genistein, Procedure: therapeutic conventional surgeryPatients receive oral genistein once daily for 3 months beginning at least 1 month prior to radical prostatectomy. |
| Arm II | Placebo comparator | Other: placebo, Procedure: therapeutic conventional surgeryPatients receive an oral placebo once daily for 3 months beginning at least 1 month prior to radical prostatectomy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Participants must have a pathologic diagnosis of prostate cancer within the past 6 months, have clinical stage T1-3 disease, PSA >= 10, Gleason score >= 8, and have elected to undergo radical prostatectomy; those found to have detectable circulating prostate cancer cells in the blood as detected by qRT-PCR for PSA will be eligible to proceed onto the treatment phase of the protocol; pathology slides used for diagnosis will be submitted to the SPORE tissue pathology core for review
- ECOG performance status 0-1
- Hemoglobin > 9.0gm/dl
- Platelets >= 100 K/uL
- ANC > 1000/uL
Key exclusion criteria (5 listed)
- History of venous thrombosis within past year
- Participants must not be receiving active therapy for neoplastic disorders (including hormone or radiation therapy for prostate cancer)
- Participants may not be receiving any other investigational agents
- Known soy intolerance
- Medical conditions that, in the opinion of the investigators, would jeopardize either the patient or the integrity of the data obtained
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 |
|---|---|---|
| genisteinAlso: CI 75610, Genestein, genisteol, genisterinGiven orally | Dietary supplement | Arm I |
| placeboAlso: PLCBGiven orally | Other | Arm II |
| therapeutic conventional surgeryRadical prostatectomy for treatment of prostate cancer | Procedure or surgery | Arm I, Arm II |
Primary outcome
Number of Circulating Prostate Cells (CPCs) in the Blood as Determined by qRT-PCR for PSA on RNA Extracted From PBMNCs
Time frame: At screening, after 1-month of treatment, at surgery and at 1 and 12 months after surgery
Blood will be collected to analyze the number of CPC's at screening, after 1-month of treatment, at surgery and at 1 and 12 months after surgery.
3 secondary outcomes
Natural History of Circulating Prostate Cells (CPCs) in a Cohort of Subjects Prior to and Post Radical Prostatectomy
Time frame: At baseline, 1 and 12 months after surgery
Measure the Effect of Genistein on Select Gene and Protein Expressions in Prostate Tissue
Time frame: At baseline and at time of surgery
Measurement of PSA in Serum and Plasma by Nanotechnology
Time frame: At screening, after 1-month of treatment, at surgery and at 1 and 12 months after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
William Catalona principal investigator
Northwestern University
1 site 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 therapeutic conventional surgery in people with Adenocarcinoma of the Prostate and Recurrent Prostate Cancer, run by Northwestern University at 1 site 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?
The sponsor lists 11 inclusion and 5 exclusion criteria. 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 10 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 2 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Circulating Prostate Cells (CPCs) in the Blood as Determined by qRT-PCR for PSA on RNA Extracted From PBMNCs (time frame: At screening, after 1-month of treatment, at surgery and at 1 and 12 months after surgery). 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 10 Sep 2019.