Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00214422
Status:
COMPLETED
Last Update Posted:
2019-07-19
First Post:
2006-06-19
Brief Title:
Intensity Modulated Radiation Therapy for Prostate Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Pilot Study of Image Guided Prostate and Pelvic Nodal Irradiation With Intensity Modulated Radiation Therapy IMRT in Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2019-07
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:
BACKGROUND
-This study represents a progression from findings in four previous National Cancer Institute NCI Radiation Oncology Branch ROB protocols 02-C-0167A 02-C-0207E 03-C-0190B 04-C-0171 In these previous works we have begun to develop techniques to obtain Magnetic Resonance MR biological images and co-register tissue in prostate cancer patients
OBJECTIVES
-The primary objective of the first portion of this study is to assess the feasibility of using Intensity-modulated radiation therapy IMRT to treat the at-risk lymph nodes in prostate cancer Also if feasible we hope optimize this technique with experience
ELIGIBILITY
-This is a study of image guided targeted radiation therapy in patients with high risk of nodal metastases from prostate cancer Patients with prostate cancer who have more than 15 risk of lymph node as defined by the Partin tables metastasis will be eligible for this study
DESIGN
On the first 10 patients we will perform approximately 5 computed tomography CT simulations throughout the course of their therapy On each simulation the initial treatment plan will be re-run The dose-volume data from target and normal tissues will then be re-analyzed From this analysis we will be better able to determine the size of margins needed to account for organ motion and changes such as varying amounts of gas in the bowel and fluid in the bladder To the best of our knowledge no such analyses have been published
If the initial part of this trial is feasible we will proceed to a phase I dose escalation trial of radiation to the at-risk lymph nodes The primary statistical objective of the phase I portion of this study is to estimate the Maximum Tolerated Dose MTD of external beam radiation based on evaluating acute toxicity The study will be conducted with a dose-escalation design with 3 patients in each dose cohort If fewer than 2 of 3 patients experience an acute dose limiting toxicity DLT than patients will be accrued to the next dose cohort If 2 or more of 3 patients experience a DLT then the MTD will be exceeded and the prior lower dose cohort will be considered the MTD Secondary objectives of this study are to relate patterns in gene and protein expression to response and toxicity and to evaluate the frequency of late term toxicity
Specific procedures and risks will be described in a separate consent to be obtained at the time of biopsy Tissue samples will be processed for complementary deoxyribonucleic acid cDNA microarray testing and stored for future analysis in the Radiation Oncology Branch NCI
Anatomic Magnetic Resonance Imaging MRI and magnetic resonance MR biological images of the prostate and pelvis will be obtained and tissue will be acquired with biopsy locations precisely translated co-registered to an MR image of reference A fiducial marker gold seed will be left at the biopsy site as a fiducial marker to direct future radiation therapy to the prostate If necessary additional fiducial markers will be placed for prostate localization during treatment
-This study represents a progression from findings in four previous National Cancer Institute NCI Radiation Oncology Branch ROB protocols 02-C-0167A 02-C-0207E 03-C-0190B 04-C-0171 In these previous works we have begun to develop techniques to obtain Magnetic Resonance MR biological images and co-register tissue in prostate cancer patients
OBJECTIVES
-The primary objective of the first portion of this study is to assess the feasibility of using Intensity-modulated radiation therapy IMRT to treat the at-risk lymph nodes in prostate cancer Also if feasible we hope optimize this technique with experience
ELIGIBILITY
-This is a study of image guided targeted radiation therapy in patients with high risk of nodal metastases from prostate cancer Patients with prostate cancer who have more than 15 risk of lymph node as defined by the Partin tables metastasis will be eligible for this study
DESIGN
On the first 10 patients we will perform approximately 5 computed tomography CT simulations throughout the course of their therapy On each simulation the initial treatment plan will be re-run The dose-volume data from target and normal tissues will then be re-analyzed From this analysis we will be better able to determine the size of margins needed to account for organ motion and changes such as varying amounts of gas in the bowel and fluid in the bladder To the best of our knowledge no such analyses have been published
If the initial part of this trial is feasible we will proceed to a phase I dose escalation trial of radiation to the at-risk lymph nodes The primary statistical objective of the phase I portion of this study is to estimate the Maximum Tolerated Dose MTD of external beam radiation based on evaluating acute toxicity The study will be conducted with a dose-escalation design with 3 patients in each dose cohort If fewer than 2 of 3 patients experience an acute dose limiting toxicity DLT than patients will be accrued to the next dose cohort If 2 or more of 3 patients experience a DLT then the MTD will be exceeded and the prior lower dose cohort will be considered the MTD Secondary objectives of this study are to relate patterns in gene and protein expression to response and toxicity and to evaluate the frequency of late term toxicity
Specific procedures and risks will be described in a separate consent to be obtained at the time of biopsy Tissue samples will be processed for complementary deoxyribonucleic acid cDNA microarray testing and stored for future analysis in the Radiation Oncology Branch NCI
Anatomic Magnetic Resonance Imaging MRI and magnetic resonance MR biological images of the prostate and pelvis will be obtained and tissue will be acquired with biopsy locations precisely translated co-registered to an MR image of reference A fiducial marker gold seed will be left at the biopsy site as a fiducial marker to direct future radiation therapy to the prostate If necessary additional fiducial markers will be placed for prostate localization during treatment
Detailed Description:
BACKGROUND
-This study represents a progression from findings in four previous National Cancer Institute NCI Radiation Oncology Branch ROB protocols 02-C-0167A 02-C-0207E 03-C-0190B 04-C-0171 In these previous works we have begun to develop techniques to obtain Magnetic Resonance MR biological images and co-register tissue in prostate cancer patients
OBJECTIVES
-The primary objective of the first portion of this study is to assess the feasibility of using Intensity-modulated radiation therapy IMRT to treat the at-risk lymph nodes in prostate cancer Also if feasible we hope optimize this technique with experience
ELIGIBILITY
This is a study of image guided targeted radiation therapy in patients with high risk of nodal metastases from prostate cancer
Patients with prostate cancer who have more than 15 risk of lymph node as defined by the Partin tables metastasis will be eligible for this study
DESIGN
On the first 10 patients we will perform approximately 5 computed tomography CT simulations throughout the course of their therapy On each simulation the initial treatment plan will be re-run The dose-volume data from target and normal tissues will then be re-analyzed From this analysis we will be better able to determine the size of margins needed to account for organ motion and changes such as varying amounts of gas in the bowel and fluid in the bladder To the best of our knowledge no such analyses have been published
If the initial part of this trial is feasible we will proceed to a phase I dose escalation trial of radiation to the at-risk lymph nodes The primary statistical objective of the phase I portion of this study is to estimate the Maximum Tolerated Dose MTD of external beam radiation based on evaluating acute toxicity The study will be conducted with a dose-escalation design with 3 patients in each dose cohort If fewer than 2 of 3 patients experience an acute dose limiting toxicity DLT than patients will be accrued to the next dose cohort If 2 or more of 3 patients experience a DLT then the MTD will be exceeded and the prior lower dose cohort will be considered the MTD Secondary objectives of this study are to relate patterns in gene and protein expression to response and toxicity and to evaluate the frequency of late term toxicity
Specific procedures and risks will be described in a separate consent to be obtained at the time of biopsy Tissue samples will be processed for complementary deoxyribonucleic acid cDNA microarray testing and stored for future analysis in the Radiation Oncology Branch NCI
Anatomic Magnetic Resonance Imaging MRI and magnetic resonance MR biological images of the prostate and pelvis will be obtained and tissue will be acquired with biopsy locations precisely translated co-registered to an MR image of reference A fiducial marker gold seed will be left at the biopsy site as a fiducial marker to direct future radiation therapy to the prostate If necessary additional fiducial markers will be placed for prostate localization during treatment
-This study represents a progression from findings in four previous National Cancer Institute NCI Radiation Oncology Branch ROB protocols 02-C-0167A 02-C-0207E 03-C-0190B 04-C-0171 In these previous works we have begun to develop techniques to obtain Magnetic Resonance MR biological images and co-register tissue in prostate cancer patients
OBJECTIVES
-The primary objective of the first portion of this study is to assess the feasibility of using Intensity-modulated radiation therapy IMRT to treat the at-risk lymph nodes in prostate cancer Also if feasible we hope optimize this technique with experience
ELIGIBILITY
This is a study of image guided targeted radiation therapy in patients with high risk of nodal metastases from prostate cancer
Patients with prostate cancer who have more than 15 risk of lymph node as defined by the Partin tables metastasis will be eligible for this study
DESIGN
On the first 10 patients we will perform approximately 5 computed tomography CT simulations throughout the course of their therapy On each simulation the initial treatment plan will be re-run The dose-volume data from target and normal tissues will then be re-analyzed From this analysis we will be better able to determine the size of margins needed to account for organ motion and changes such as varying amounts of gas in the bowel and fluid in the bladder To the best of our knowledge no such analyses have been published
If the initial part of this trial is feasible we will proceed to a phase I dose escalation trial of radiation to the at-risk lymph nodes The primary statistical objective of the phase I portion of this study is to estimate the Maximum Tolerated Dose MTD of external beam radiation based on evaluating acute toxicity The study will be conducted with a dose-escalation design with 3 patients in each dose cohort If fewer than 2 of 3 patients experience an acute dose limiting toxicity DLT than patients will be accrued to the next dose cohort If 2 or more of 3 patients experience a DLT then the MTD will be exceeded and the prior lower dose cohort will be considered the MTD Secondary objectives of this study are to relate patterns in gene and protein expression to response and toxicity and to evaluate the frequency of late term toxicity
Specific procedures and risks will be described in a separate consent to be obtained at the time of biopsy Tissue samples will be processed for complementary deoxyribonucleic acid cDNA microarray testing and stored for future analysis in the Radiation Oncology Branch NCI
Anatomic Magnetic Resonance Imaging MRI and magnetic resonance MR biological images of the prostate and pelvis will be obtained and tissue will be acquired with biopsy locations precisely translated co-registered to an MR image of reference A fiducial marker gold seed will be left at the biopsy site as a fiducial marker to direct future radiation therapy to the prostate If necessary additional fiducial markers will be placed for prostate localization during treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| 05-C-0241 | None | None | None |