Ignite Creation Date:
2024-05-05 @ 5:25 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00450749
Status:
COMPLETED
Last Update Posted:
2019-12-18
First Post:
2007-03-20
Brief Title:
Lycopene in Treating Patients Undergoing Radical Prostatectomy for Prostate Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Placebo Controlled Trial of Preoperative Lycopene Supplementation in Prostate Cancer Patients
Status:
COMPLETED
Status Verified Date:
2019-12
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 randomized phase II trial studies how well different doses of lycopene work in treating patients undergoing radical prostatectomy for prostate cancer The use of lycopene a substance found in tomatoes may keep prostate cancer from growing or coming back after surgery
Detailed Description:
PRIMARY OBJECTIVES
I Compare the differences in tissue concentrations of lycopene in patients with prostate cancer undergoing radical prostatectomy treated with different doses of neoadjuvant lycopene supplementation
II Compare the change in serum lycopene concentration from baseline and at 4-7 weeks in patients treated with different doses of lycopene
SECONDARY OBJECTIVES
I Determine the effect of this treatment in down-regulating 5-alpha-reductase activity by measuring the change in the ratio of testosterone T to dihydrotestosterone DHT in serum at baseline and at 4-7 weeks and the ratio of TDHT in prostatic surgical tissue post-treatment
II Determine the effect of this treatment in attenuating baseline blood serum concentrations of total prostate-specific antigen PSA free PSA and human kallikrein 2 in these patients
III Determine the effect of this treatment on growth potential by examining post-treatment radical prostatectomy tissue specimens for proliferative index PI by Ki-67 expression apoptotic index AI by TUNEL assay and PIAI ratio in these patients
IV Determine the effect of this treatment in modulating putative biomarkers of lycopene efficacy including serum concentrations of insulin-like growth factor IGF-1 and IGF binding protein-3 lymphocyte oxidative DNA damage capacity by Comet assay and GST-pi expression in prostatic tissue from these patients
V Compare the histological effect of different doses of lycopene on putative prognostic features including the presence and extent of high-grade prostatic intraepithelial neoplasia prostatitis total tumor volume local invasion vascular and lymphatic capsular seminal vesicle pathologic stage Gleason score surgical margins and lymph node status in these patients
VI Determine the effect of this treatment in modulating the RNA expression of androgen-related genes by microarray analysis in these patients
OUTLINE
This is a randomized placebo-controlled double-blind multicenter study Patients are stratified according to participating center Patients are randomized to 1 of 3 treatment arms
ARM I Patients receive placebo orally PO once daily QD for 4-7 weeks and then undergo radical prostatectomy
ARM II Patients receive low-dose lycopene PO QD for 4-7 weeks and then undergo radical prostatectomy
ARM III Patients receive high-dose lycopene PO QD for 4-7 weeks and then undergo radical prostatectomy
Tumor samples are collected from prostatectomy for laboratory studies including GST-pi expression by immunohistochemistry histological analysis microarray analysis of androgen-related genes ratio of testosterone T to dihydrotestosterone DHT Ki-67 expression and lycopene tumor-concentration measurement
Patients undergo blood collection at baseline week 4 and week 7 for laboratory studies including serum lycopene concentration measurement level of T or DHT by high-performance liquid chromatographytandem mass spectrometry HPLCMSMS analysis serum concentrations of total prostate-specific antigen PSA free PSA and human kallikrein 2 lymphocyte oxidative DNA damage capacity and serum concentrations of insulin-like growth factor IGF-1 and IGF binding protein-3 by radioimmunological assay
I Compare the differences in tissue concentrations of lycopene in patients with prostate cancer undergoing radical prostatectomy treated with different doses of neoadjuvant lycopene supplementation
II Compare the change in serum lycopene concentration from baseline and at 4-7 weeks in patients treated with different doses of lycopene
SECONDARY OBJECTIVES
I Determine the effect of this treatment in down-regulating 5-alpha-reductase activity by measuring the change in the ratio of testosterone T to dihydrotestosterone DHT in serum at baseline and at 4-7 weeks and the ratio of TDHT in prostatic surgical tissue post-treatment
II Determine the effect of this treatment in attenuating baseline blood serum concentrations of total prostate-specific antigen PSA free PSA and human kallikrein 2 in these patients
III Determine the effect of this treatment on growth potential by examining post-treatment radical prostatectomy tissue specimens for proliferative index PI by Ki-67 expression apoptotic index AI by TUNEL assay and PIAI ratio in these patients
IV Determine the effect of this treatment in modulating putative biomarkers of lycopene efficacy including serum concentrations of insulin-like growth factor IGF-1 and IGF binding protein-3 lymphocyte oxidative DNA damage capacity by Comet assay and GST-pi expression in prostatic tissue from these patients
V Compare the histological effect of different doses of lycopene on putative prognostic features including the presence and extent of high-grade prostatic intraepithelial neoplasia prostatitis total tumor volume local invasion vascular and lymphatic capsular seminal vesicle pathologic stage Gleason score surgical margins and lymph node status in these patients
VI Determine the effect of this treatment in modulating the RNA expression of androgen-related genes by microarray analysis in these patients
OUTLINE
This is a randomized placebo-controlled double-blind multicenter study Patients are stratified according to participating center Patients are randomized to 1 of 3 treatment arms
ARM I Patients receive placebo orally PO once daily QD for 4-7 weeks and then undergo radical prostatectomy
ARM II Patients receive low-dose lycopene PO QD for 4-7 weeks and then undergo radical prostatectomy
ARM III Patients receive high-dose lycopene PO QD for 4-7 weeks and then undergo radical prostatectomy
Tumor samples are collected from prostatectomy for laboratory studies including GST-pi expression by immunohistochemistry histological analysis microarray analysis of androgen-related genes ratio of testosterone T to dihydrotestosterone DHT Ki-67 expression and lycopene tumor-concentration measurement
Patients undergo blood collection at baseline week 4 and week 7 for laboratory studies including serum lycopene concentration measurement level of T or DHT by high-performance liquid chromatographytandem mass spectrometry HPLCMSMS analysis serum concentrations of total prostate-specific antigen PSA free PSA and human kallikrein 2 lymphocyte oxidative DNA damage capacity and serum concentrations of insulin-like growth factor IGF-1 and IGF binding protein-3 by radioimmunological assay
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 |
|---|---|---|---|
| CDR0000532938 | None | None | None |
| NCI-2009-00857 | REGISTRY | None | None |
| MSKCC-06118 | None | None | None |
| MDA-CC-2006-0388 | None | None | None |
| CDR0000653464 | None | None | None |
| 06-118 | None | None | None |
| 2006-0388 | OTHER | None | None |
| P30CA016672 | NIH | None | None |
| MDA04-3-01 | OTHER | None | None |
| N01CN35159 | NIH | DCP | httpsreporternihgovquickSearchN01CN35159 |