Prostate CancerNCT01174953
High Risk Prostate Cancer Prevention Study
A study testing finasteride in people with Prostate Cancer, run by University of Kansas at 2 sites in United States.
Trial summary
The purpose of this study is to study the molecular effects of the chemopreventative agent, finasteride, in combination with dietary soy supplementation in patients at high risk for the development of prostate cancer. Read more about this study
- Who is it for?
- Ages 55 to 95 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- finasteride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2010to Mar 2013
- Phase
- Interventional
- 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 55 to 95 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Based on the PSA, DRE and Family history of prostate cancer patients will be risk stratified using Prostate Cancer Risk Calculator. Must have at least 25% chance of prostate cancer development as assessed by the prostate cancer risk calculator.
- During time of study period, patients must agree not to take any new vitamin supplementation, soy or herbal supplement.
- Must not be receiving concurrent chemotherapy, radiation or hormonal therapy.
- No history of prior allergy and intolerability to soy-based products.
- Must not have been taking any soy supplementation, soy isoflavones or finasteride within 90 days prior to study enrollment.
- Must be able to safely be on study supplements for period of at least four months.
- All patients must have been informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.
- All patients must be willing to undergo prestudy and follow-up assessment, including prostate biopsies.
Who cannot join
- Patients diagnosed with prostate cancer on initial biopsy
- Patients with any active malignancy
- Receiving any concurrent chemotherapy, hormonal therapy or radiation
- Patient not compliant with treatment for at least 4 months
- Patients with history of deep vein thrombosis, myocardial infarction, coronary artery disease,and cerebrovascular accident in the last 6 months will also be excluded.
- Patients on active anticoagulation will be excluded.
- Patients with liver function tests more than 2 levels of upper limit of normal
- Patients who develop more than grade 2 toxicity will also be removed from the study
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Kansas Medical Center
Kansas City, Kansas, 66160
Veterans Administration Medical Centenr
Kansas City, Missouri, 64128
About this study
The purpose of this study is to study the molecular effects of the chemopreventative agent, finasteride, in combination with dietary soy supplementation in patients at high risk for the development of prostate cancer. Also, the investigators intend to create a large database with health information from men who are at high risk of developing prostate cancer, along with serum and tissue samples from those patients who are willing to provide tissue and serum samples.
Read the detailed description
Over 180,000 new cases of prostate cancer are diagnosed in the United States each year, making prostate cancer the most frequently diagnosed cancer in men. With an estimated 28,660 deaths occurring in 2008, prostate cancer is the second leading cause of cancer death in men. In Kansas, prostate cancer is also the most frequent cancer among men and ranked third (253 deaths in 2006) behind lung cancer (884 deaths in 2006) and colorectal cancer (273 deaths in 2006) in cancer related mortality. Despite the significant morbidity and mortality related to this disease, screening and treatment approaches remain controversial and there is significant morbidity related to the treatment of early stage disease. Preventative strategies and strategies which identify patients at highest risk are needed desperately.
The goal of this proposal is to study the molecular effects of the chemopreventative agent, finasteride in combination with dietary soy supplementation in patients at high risk for the development prostate cancer.
- Conditions
- Prostate Cancer
- Being tested
- finasteride
- Keywords
- 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.
finasterideDrug
Also called Proscar, Propecia, isolavone
Finasteride 5 mg once daily
Soy 4 capsules twice daily (160 mg total)
| Study group | Role | What they receive |
|---|---|---|
| Finasteride plus soy | Other | Finasteride and soy Receives: Drug: finasteride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomarkers will be identified to help predict future prostate cancer risks and patients likely to benefit from preventive strategies
Measured: 2 years from completion of enrollment
Secondary outcomes (1)
provide a platform ongoing evaluation of novel preventive agents
Measured: approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2010 (estimated)
- Study startJul 2010
- Primary completionMar 2013
- Study completionMar 2013
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.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter J Van Veldhuizen, MD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01174953
- Sponsor's protocol ID
- 12052
- Status last verified
- Dec 2013
- First submitted
- 26 Jul 2010
- Last updated
- 1 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Risk Prostate Cancer Prevention Study
- ClinicalTrials.gov ID
- NCT01174953
- Acronym / sponsor ID
- 12052
- Conditions
- Prostate Cancer
- Keywords
- prostate cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of KansasUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 4 Aug 2010 (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.
The purpose of this study is to study the molecular effects of the chemopreventative agent, finasteride, in combination with dietary soy supplementation in patients at high risk for the development of prostate cancer. Also, the investigators intend to create a large database with health information from men who are at high risk of developing prostate cancer, along with serum and tissue samples from those patients who are willing to provide tissue and serum samples.
Detailed description
Over 180,000 new cases of prostate cancer are diagnosed in the United States each year, making prostate cancer the most frequently diagnosed cancer in men. With an estimated 28,660 deaths occurring in 2008, prostate cancer is the second leading cause of cancer death in men. In Kansas, prostate cancer is also the most frequent cancer among men and ranked third (253 deaths in 2006) behind lung cancer (884 deaths in 2006) and colorectal cancer (273 deaths in 2006) in cancer related mortality. Despite the significant morbidity and mortality related to this disease, screening and treatment approaches remain controversial and there is significant morbidity related to the treatment of early stage disease. Preventative strategies and strategies which identify patients at highest risk are needed desperately.
The goal of this proposal is to study the molecular effects of the chemopreventative agent, finasteride in combination with dietary soy supplementation in patients at high risk for the development prostate cancer.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Finasteride plus soy | Other | Drug: finasterideFinasteride and soy |
Who may qualify
- Ages
- 55 to 95 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Based on the PSA, DRE and Family history of prostate cancer patients will be risk stratified using Prostate Cancer Risk Calculator. Must have at least 25% chance of prostate cancer development as assessed by the prostate cancer risk calculator.
- During time of study period, patients must agree not to take any new vitamin supplementation, soy or herbal supplement.
- Must not be receiving concurrent chemotherapy, radiation or hormonal therapy.
- No history of prior allergy and intolerability to soy-based products.
- Must not have been taking any soy supplementation, soy isoflavones or finasteride within 90 days prior to study enrollment.
Key exclusion criteria (8 listed)
- Patients diagnosed with prostate cancer on initial biopsy
- Patients with any active malignancy
- Receiving any concurrent chemotherapy, hormonal therapy or radiation
- Patient not compliant with treatment for at least 4 months
- Patients with history of deep vein thrombosis, myocardial infarction, coronary artery disease,and cerebrovascular accident in the last 6 months will also be excluded.
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 |
|---|---|---|
| finasterideAlso: Proscar, Propecia, isolavoneFinasteride 5 mg once daily Soy 4 capsules twice daily (160 mg total) | Drug | Finasteride plus soy |
Primary outcome
Biomarkers will be identified to help predict future prostate cancer risks and patients likely to benefit from preventive strategies
Time frame: 2 years from completion of enrollment
1 secondary outcome
provide a platform ongoing evaluation of novel preventive agents
Time frame: approximately 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jan 2014.
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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.
Peter J Van Veldhuizen, MD principal investigator
University of Kansas Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing finasteride in people with Prostate Cancer, run by University of Kansas at 2 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?
The sponsor lists 8 inclusion and 8 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: finished, as of the sponsor's last update on 1 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Biomarkers will be identified to help predict future prostate cancer risks and patients likely to benefit from preventive strategies (time frame: 2 years from completion of enrollment). 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 1 Jan 2014.