Ignite Creation Date:
2025-12-25 @ 12:20 AM
Ignite Modification Date:
2026-01-02 @ 5:32 AM
Study NCT ID:
NCT00598858
Status:
WITHDRAWN
Last Update Posted:
2016-12-08
First Post:
2008-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neoadjuvant Docetaxel on Newly Diagnosed Intermediate and High Grade Cancer of the Prostate
Sponsor:
John P. Fruehauf
Organization:
Study Overview
Official Title:
Phase II Study to Determine the Effects of Neoadjuvant Docetaxel on Newly Diagnosed Intermediate and High Grade Cancer of the Prostate in Patients Who Are Scheduled for Radical Prostatectomy With Genomic Correlates of Pathological Response
Status:
WITHDRAWN
Status Verified Date:
2013-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Halted due to zero accrual and lack of funding
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
2007-5904
Brief Summary:
This pilot phase II trial studies docetaxel and prednisone in treating patients with newly diagnosed stage I-II prostate cancer undergoing prostatectomy. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Biological therapies, such as prednisone, may stimulate the immune system in different ways and stop cancer cells from growing. Giving docetaxel and prednisone together may kill more tumor cells.
Detailed Description:
PRIMARY OBJECTIVES:
I. To determine the rate of a 3-month prostate-specific antigen (PSA) decline of at least 30% by chemotherapy regimen of docetaxel and prednisone in patients with stage I/II prostate cancer, who are scheduled for prostatectomy.
II. To compare tumor, pathological and PSA responses to neoadjuvant docetaxel between patients with intermediate and high grades of prostate cancer.
III. To obtain prostate specimens for genomic correlates with responses of the chemotherapy regimen of docetaxel and prednisone.
OUTLINE:
Patients receive docetaxel intravenously (IV) over 60 minutes on days 1 and 2 and prednisone orally (PO) twice daily (BID) on days 1-21. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients undergo prostatectomy within 3 weeks after completion of chemotherapy.
After completion of study treatment, patients are followed up within 7 days.
I. To determine the rate of a 3-month prostate-specific antigen (PSA) decline of at least 30% by chemotherapy regimen of docetaxel and prednisone in patients with stage I/II prostate cancer, who are scheduled for prostatectomy.
II. To compare tumor, pathological and PSA responses to neoadjuvant docetaxel between patients with intermediate and high grades of prostate cancer.
III. To obtain prostate specimens for genomic correlates with responses of the chemotherapy regimen of docetaxel and prednisone.
OUTLINE:
Patients receive docetaxel intravenously (IV) over 60 minutes on days 1 and 2 and prednisone orally (PO) twice daily (BID) on days 1-21. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients undergo prostatectomy within 3 weeks after completion of chemotherapy.
After completion of study treatment, patients are followed up within 7 days.
Study Oversight
Has Oversight DMC:
True
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?: