Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00178113
Status:
COMPLETED
Last Update Posted:
2015-05-27
First Post:
2005-09-13
Brief Title:
A Pilot Study of Lycopene Supplementation in Prostatic Intraepithelial Neoplasia
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Phase I Clinical Trial Randomized Lycopene Supplementation in Tobago Men With High-Grade Prostatic-Intraepithelial Neoplasia
Status:
COMPLETED
Status Verified Date:
2015-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine whether dietary lycopene supplementation lowers serum prostate specific antigenPSA in men with high grade intraepithelial neoplasia HGPIN
Detailed Description:
Observational studies suggest higher lycopene intake or higher lycopene blood levels are associated with a lower risk for prostate cancer Two recent trials of lycopene supplementation conducted in men with prostate cancer during the three weeks prior to radical prostatectomy found a reduction in serum PSA suggesting a regression of prostate cancer
High grade intraepithelial neoplasia HGPINis thought to be a precancerous lesion and men with HGPIN have an elevated risk of prostate cancer diagnosis on subsequent biopsy The objective of this study is to determine whether dietary lycopene supplementation lowers serum prostate specific antigenPSAover four months of supplementation Serum PSA is compared in men randomized to 30 mgday lycopene plus a standard multivitamin versus standard multivitamin alone
High grade intraepithelial neoplasia HGPINis thought to be a precancerous lesion and men with HGPIN have an elevated risk of prostate cancer diagnosis on subsequent biopsy The objective of this study is to determine whether dietary lycopene supplementation lowers serum prostate specific antigenPSAover four months of supplementation Serum PSA is compared in men randomized to 30 mgday lycopene plus a standard multivitamin versus standard multivitamin alone
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 |
|---|---|---|---|
| P200202-134PRC02-134 | None | None | None |