Ignite Creation Date:
2024-05-06 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 12:53 PM
Study NCT ID:
NCT03665922
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-07-11
First Post:
2018-09-05
Brief Title:
Biomarkers of SulforaphaneBroccoli Sprout Extract in Prostate Cancer
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Biomarkers of SulforaphaneBroccoli Sprout Extract in Prostate Cancer
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
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:
This study will test whether oral intake of a dietary supplement called BroccoMax which is a special blend of broccoli extract containing a chemical called sulforaphane hereafter abbreviated as SFN may result in changes in chemicals that feed prostate cancer BroccoMax is available over the counter
Detailed Description:
Eligible subjects will be randomly assigned to either BroccoMax or placebo arm with a 11 randomization Each subject will be given BroccoMax equivalent to 4 weeks supply Following randomization subjects will begin to take four study tablets BroccoMax or placebo in the morning with breakfast and four tablets in the evening with dinner The eight BroccoMax tablets will provide a daily internal dose of 64 mg of SFN
Baseline evaluation will be 28 days before scheduled prostatectomy the same day of study drug dispensation and will include
1 Data collection on patients medical history which includes age cancer history review of medications food intolerances and food habits and concomitant medications
2 Physical exam including height and weight measurements
3 Blood approximately 15 mL will be collected in Serum Separator Tube-tiger tubes SSTfor determination of SFN and its metabolite levels and for biomarker analyses
4 Spot urine collection 15 mL for measuring SFN and its metabolite levels
5 Four-week supply of study drug BroccoMax or Placebo dispensation
Day 28 3 days End of study evaluation
1 Physical exam including height and weight measurements
2 Blood approximately 15 mL will be collected in SST-tiger tubes for determination of SFN and its metabolite levels and for biomarker analyses
3 Spot urine collection 15 mL for measuring SFN and its metabolite levels
4 Adverse event assessment
5 A portion of the prostate tumor after surgical resection will be fresh frozen in liquid nitrogen
6 After pathological assessment is complete tumor blocks or slides 6 or more will be requested by the clinical research coordinator from the Health Sciences Tissue Bank of the University of Pittsburgh for biomarker analyses
Post-Treatment Follow-Up All study participants will have routine follow-up as determined by their treating urologist and or medical oncologist This usually occurs 6 2 weeks post-surgery and every 3 months thereafter These are considered standard of care visits The patient chart will be reviewed for their history and physical findings at these visits
Baseline evaluation will be 28 days before scheduled prostatectomy the same day of study drug dispensation and will include
1 Data collection on patients medical history which includes age cancer history review of medications food intolerances and food habits and concomitant medications
2 Physical exam including height and weight measurements
3 Blood approximately 15 mL will be collected in Serum Separator Tube-tiger tubes SSTfor determination of SFN and its metabolite levels and for biomarker analyses
4 Spot urine collection 15 mL for measuring SFN and its metabolite levels
5 Four-week supply of study drug BroccoMax or Placebo dispensation
Day 28 3 days End of study evaluation
1 Physical exam including height and weight measurements
2 Blood approximately 15 mL will be collected in SST-tiger tubes for determination of SFN and its metabolite levels and for biomarker analyses
3 Spot urine collection 15 mL for measuring SFN and its metabolite levels
4 Adverse event assessment
5 A portion of the prostate tumor after surgical resection will be fresh frozen in liquid nitrogen
6 After pathological assessment is complete tumor blocks or slides 6 or more will be requested by the clinical research coordinator from the Health Sciences Tissue Bank of the University of Pittsburgh for biomarker analyses
Post-Treatment Follow-Up All study participants will have routine follow-up as determined by their treating urologist and or medical oncologist This usually occurs 6 2 weeks post-surgery and every 3 months thereafter These are considered standard of care visits The patient chart will be reviewed for their history and physical findings at these visits
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| CA225716 | OTHER_GRANT | NCI | None |