Ignite Creation Date:
2024-05-05 @ 4:49 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00321698
Status:
TERMINATED
Last Update Posted:
2022-05-13
First Post:
2006-05-02
Brief Title:
Radiation Therapy and Docetaxel in Treating Patients Who Are Undergoing Surgery for Localized Prostate Cancer
Sponsor:
OHSU Knight Cancer Institute
Organization:
OHSU Knight Cancer Institute
Study Overview
Official Title:
Phase III Study of Preoperative Radiation and Docetaxel Activity in High Risk Localized Prostate Cancer
Status:
TERMINATED
Status Verified Date:
2024-08
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Funding withdrawal
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Radiation therapy uses high-energy x-rays to kill tumor cells 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 Giving radiation therapy together with chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed
PURPOSE This phase III trial is studying the side effects and best dose of docetaxel when given together with radiation therapy and to see how well they work in treating patients who are undergoing surgery for high-risk localized prostate cancer
PURPOSE This phase III trial is studying the side effects and best dose of docetaxel when given together with radiation therapy and to see how well they work in treating patients who are undergoing surgery for high-risk localized prostate cancer
Detailed Description:
OBJECTIVES
Primary
Determine the maximum tolerated dose MTD of neoadjuvant radiotherapy and docetaxel in patients who are undergoing prostatectomy for high-risk localized prostate cancer
Determine the pathologic response rate in patients treated at the phase II dose
Secondary
Determine the prostate-specific antigen PSA short-term response rate in patients treated with this regimen
Determine the long-term safety of this regimen prior to radical prostatectomy in these patients
Determine the clinical response to this regimen by urologic examination of these patients
Determine the surgical margin status at the time of prostatectomy in patients treated with this regimen
Determine the effect of this regimen in terms of Health-Related Quality of Life by Expanded Prostate Cancer Index Composite EPIC and urinary symptom scores by the American Urological Associations measures in these patients
Determine the clinical progression-free rate in patients treated with this regimen
Identify pretreatment predictors of response in these patients by examining tissue biomarkers in preserved pretreatment biopsy specimens
Determine the biologic impact of this regimen on these patients by examining the prostatectomy specimens
Collect frozen serum for future analysis of correlative biomarkers
Compare the RNA content gene expression profile of pre- and post-treatment tumor specimens in order to describe the molecular impact of this regimen on prostate cancer
OUTLINE This is a phase I dose-escalation study of docetaxel followed by a phase II study All patients undergo a biopsy of the prostate to gather research-only specimens prior to the beginning of treatment
Phase I Patients undergo radiotherapy once daily 5 days a week for 5 weeks Patients also receive docetaxel IV on days 1 8 15 22 and 29 Treatment continues in the absence of disease progression or unacceptable toxicity Approximately 4-6 weeks after completion of chemoradiotherapy patients undergo a radical prostatectomy
Cohorts of 3-6 patients receive escalating doses of docetaxel until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience a dose-limiting toxicity At least 6 patients are treated at the MTD
Phase II Patients undergo radiotherapy as in phase I Patients also receive docetaxel at the MTD determined in phase I and then undergo prostatectomy as in phase I
PROJECTED ACCRUAL A total of 42 patients will be accrued for this study
Primary
Determine the maximum tolerated dose MTD of neoadjuvant radiotherapy and docetaxel in patients who are undergoing prostatectomy for high-risk localized prostate cancer
Determine the pathologic response rate in patients treated at the phase II dose
Secondary
Determine the prostate-specific antigen PSA short-term response rate in patients treated with this regimen
Determine the long-term safety of this regimen prior to radical prostatectomy in these patients
Determine the clinical response to this regimen by urologic examination of these patients
Determine the surgical margin status at the time of prostatectomy in patients treated with this regimen
Determine the effect of this regimen in terms of Health-Related Quality of Life by Expanded Prostate Cancer Index Composite EPIC and urinary symptom scores by the American Urological Associations measures in these patients
Determine the clinical progression-free rate in patients treated with this regimen
Identify pretreatment predictors of response in these patients by examining tissue biomarkers in preserved pretreatment biopsy specimens
Determine the biologic impact of this regimen on these patients by examining the prostatectomy specimens
Collect frozen serum for future analysis of correlative biomarkers
Compare the RNA content gene expression profile of pre- and post-treatment tumor specimens in order to describe the molecular impact of this regimen on prostate cancer
OUTLINE This is a phase I dose-escalation study of docetaxel followed by a phase II study All patients undergo a biopsy of the prostate to gather research-only specimens prior to the beginning of treatment
Phase I Patients undergo radiotherapy once daily 5 days a week for 5 weeks Patients also receive docetaxel IV on days 1 8 15 22 and 29 Treatment continues in the absence of disease progression or unacceptable toxicity Approximately 4-6 weeks after completion of chemoradiotherapy patients undergo a radical prostatectomy
Cohorts of 3-6 patients receive escalating doses of docetaxel until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience a dose-limiting toxicity At least 6 patients are treated at the MTD
Phase II Patients undergo radiotherapy as in phase I Patients also receive docetaxel at the MTD determined in phase I and then undergo prostatectomy as in phase I
PROJECTED ACCRUAL A total of 42 patients will be accrued for this study
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 |
|---|---|---|---|
| IIT16179 | OTHER_GRANT | None | None |
| OHSU-1581 | OTHER | None | None |
| PVAMC-11-1205 M1675 | OTHER | None | None |
| OHSU-SOL-05077-L | OTHER | None | None |
| CDR0000467219 | OTHER | None | None |
| NCI-2012-01122 | REGISTRY | CTRP Clinical Trial Reporting Program | None |