Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00020735
Status:
COMPLETED
Last Update Posted:
2015-12-02
First Post:
2001-07-11
Brief Title:
Toremifene Followed by Radical Prostatectomy in Treating Patients With Stage I or Stage II Prostate Cancer
Sponsor:
Joel Nelson MD
Organization:
University of Pittsburgh
Study Overview
Official Title:
A Phase II Randomized Controlled Clinical Trial Of The Antiestrogen GTx-006 In Subjects With Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2015-12
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:
RATIONALE Androgens can stimulate the growth of prostate cancer cells Hormone therapy using toremifene may fight prostate cancer by reducing the production of androgens
PURPOSE Randomized phase II trial to study the effectiveness of toremifene followed by radical prostatectomy in treating patients who have stage I or stage II prostate cancer
PURPOSE Randomized phase II trial to study the effectiveness of toremifene followed by radical prostatectomy in treating patients who have stage I or stage II prostate cancer
Detailed Description:
OBJECTIVES
Compare the percent of high-grade prostatic intraepithelial neoplasia HGPIN present in the radical prostatectomy tissue excluding the luminal area of patients with stage I or II adenocarcinoma of the prostate treated with toremifene vs observation alone followed by radical prostatectomy
Compare the absolute and relative changes in HGPIN in patients treated with toremifene vs observation alone
Compare biomarkers including DNA ploidy and nuclear morphology Ki67 and MIB-1 expression bcl-2 expression frequency of cells expressing apoptotic bodies microvessel density and intraprostatic testosterone dihydrotestosterone DHT and estradiol in the radical prostatectomy tissue of patients treated with toremifene vs observation alone
Compare changes from baseline in serum biomarkers particularly PSA and hormone profiles testosterone DHT androstenedione dehydroepiandrosterone androstanediol-glucuronide estradiol and sex hormone binding globulin in patients treated with toremifene vs observation alone
Compare the safety of toremifene in these patients
Determine the relationships among pairs of biomarkers biomarker changes and outcome measures including toxicity of toremifene and posttreatment HGPIN in these patients
Determine the relationship between HGPIN or biomarker responses and antiandrogen germline CAG repeat length polymorphism in patients treated with toremifene
Compare the tumor volume margin status and pT stage in patients treated with toremifene vs observation alone
OUTLINE This is a randomized open-label multicenter study Patients are stratified according to participating center and baseline high-grade prostatic intraepithelial neoplasia none vs more than 0 up to 10 vs more than 10 Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral toremifene daily for 3-6 weeks in the absence of unacceptable toxicity
Arm II Patients undergo observation alone Patients in both arms then undergo radical prostatectomy
PROJECTED ACCRUAL A total of 78 patients 52 for arm I 26 for arm II will be accrued for this study at a rate of 6-7 patients per month
Compare the percent of high-grade prostatic intraepithelial neoplasia HGPIN present in the radical prostatectomy tissue excluding the luminal area of patients with stage I or II adenocarcinoma of the prostate treated with toremifene vs observation alone followed by radical prostatectomy
Compare the absolute and relative changes in HGPIN in patients treated with toremifene vs observation alone
Compare biomarkers including DNA ploidy and nuclear morphology Ki67 and MIB-1 expression bcl-2 expression frequency of cells expressing apoptotic bodies microvessel density and intraprostatic testosterone dihydrotestosterone DHT and estradiol in the radical prostatectomy tissue of patients treated with toremifene vs observation alone
Compare changes from baseline in serum biomarkers particularly PSA and hormone profiles testosterone DHT androstenedione dehydroepiandrosterone androstanediol-glucuronide estradiol and sex hormone binding globulin in patients treated with toremifene vs observation alone
Compare the safety of toremifene in these patients
Determine the relationships among pairs of biomarkers biomarker changes and outcome measures including toxicity of toremifene and posttreatment HGPIN in these patients
Determine the relationship between HGPIN or biomarker responses and antiandrogen germline CAG repeat length polymorphism in patients treated with toremifene
Compare the tumor volume margin status and pT stage in patients treated with toremifene vs observation alone
OUTLINE This is a randomized open-label multicenter study Patients are stratified according to participating center and baseline high-grade prostatic intraepithelial neoplasia none vs more than 0 up to 10 vs more than 10 Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral toremifene daily for 3-6 weeks in the absence of unacceptable toxicity
Arm II Patients undergo observation alone Patients in both arms then undergo radical prostatectomy
PROJECTED ACCRUAL A total of 78 patients 52 for arm I 26 for arm II will be accrued for this study at a rate of 6-7 patients per month
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 |
|---|---|---|---|
| NCI-P01-0181 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000068708 | REGISTRY | None | None |
| PCI-N01-CN-75018 | None | None | None |