Ignite Creation Date:
2024-05-05 @ 10:06 PM
Last Modification Date:
2024-10-26 @ 10:14 AM
Study NCT ID:
NCT01036321
Status:
COMPLETED
Last Update Posted:
2019-08-06
First Post:
2009-12-17
Brief Title:
Phase II Clinical Trial of Purified Isoflavones in Prostate Cancer Comparing Safety Effectiveness
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
H Lee Moffitt Cancer Center and Research Institute
Study Overview
Official Title:
Phase II Clinical Trial of Purified Isoflavones in Prostate Cancer Comparing Safety Effectiveness and Mechanism of Action Between African American and Caucasian Men
Status:
COMPLETED
Status Verified Date:
2019-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of our study is to recruit and treat 96 men diagnosed with prostate cancer and scheduled for a prostatectomy with a capsule form of either purified isoflavones or placebo for a 3-6 week period to see if we can slow down the rate of prostate cancer growth A placebo is a pill or something that looks like the medicine that is being studied but has no active medicine in it We also want to see if taking purified isoflavones is safe and if it reduces lower urinary tract symptoms In addition we want to study if purified isoflavones are able to slow the progression of prostate cancer and the mechanism of action of purified isoflavones If the safety and the effects of purified isoflavones on slowing down the progression of prostate cancer is shown in our study this will also be a safe way of treating men who are at high risk of prostate cancer so that we can prevent prostate cancer in the future
Detailed Description:
Patients will need to take two 2 capsules daily one with their breakfast and one with their dinner On the day prior or the day that patients are coming in for their pre-operative surgery blood work we ask that they take the second dose with lunch if their appointment is in the afternoon
At the start of the study and at the end of the study 3-6 weeks patients will undergo interviews complete questionnaires and have lab tests to determine if this drug is effective to reduce progression of prostate cancer and is safe to use
Patients will also receive a multivitaminmineral supplement for the 3-6 weeks that they are on this study and will be required to take one 1 every day It is required that patients not take any other vitaminmineral or herbal preparation containing isoflavones and avoid eating or drinking soy products
We anticipate that most patients will be scheduled for a prostatectomy 3-6 weeks - 3 days from start of study agent In addition to their first visit patients will be required to come in the day of the surgery for prostatectomy
At the start of the study and at the end of the study 3-6 weeks patients will undergo interviews complete questionnaires and have lab tests to determine if this drug is effective to reduce progression of prostate cancer and is safe to use
Patients will also receive a multivitaminmineral supplement for the 3-6 weeks that they are on this study and will be required to take one 1 every day It is required that patients not take any other vitaminmineral or herbal preparation containing isoflavones and avoid eating or drinking soy products
We anticipate that most patients will be scheduled for a prostatectomy 3-6 weeks - 3 days from start of study agent In addition to their first visit patients will be required to come in the day of the surgery for prostatectomy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1P20MD003375-01 | NIH | USF IRB | httpsreporternihgovquickSearch1P20MD003375-01 |
| IRB 107980 | OTHER | None | None |