Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00039624
Status:
COMPLETED
Last Update Posted:
2018-08-02
First Post:
2002-06-06
Brief Title:
Magnetic Resonance-Guided High-Dose Brachytherapy Short-Range Radiation Therapy for Prostate Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Phase II Study of MR-Guided High Dose Rate Brachytherapy Boosts For Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2018-07-31
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 study will evaluate the use of magnetic resonance imaging MRI for guiding placement of hollow needles into the prostate gland for delivering internal radiation therapy to patients with prostate cancer Prostate cancer is often treated with a combination of external beam radiation therapy and brachytherapy internal radiation delivered close to the tumor This study will determine whether MRI is more accurate in guiding needle placement than ultrasound which is currently used for this purpose Patients will have one brachytherapy treatment followed by 5 weeks of external beam treatments and a second brachytherapy
Patients 18 years of age and older with prostate cancer that has not spread to the bone may be eligible for this study Candidates will be screened with a physical examination blood and urine tests and a bone scan
To plan for radiation therapy patients will have standard computed tomography CT and MRI scans of the pelvis and prostate In addition CT and MRI scans will be done to determine if the prostate is in a good position for brachytherapy For these scans patients will have an enema and a tube will be placed in the rectum They will then lie still on their side for about 45 minutes during the scan Patients who have blood in their urine will also undergo cystoscopy This is an examination of the bladder using a small camera that is advanced through the penis into the bladder
Patients are given an antibiotic for 2 days before the brachytherapy and on the morning of the procedure Before the test they have a small enema and are given medicines through the vein and into the spine for relaxation and to decrease any discomfort The test is done under general anesthesia for patients who require it The patient is moved on a stretcher into the MRI scanner and a catheter is inserted into the bladder through the penis The bladder is filled with water and a tube is placed in the rectum With the help of a plastic guide placed against the skin about 14 to 18 needles are then placed in the prostate Some stitches are sewn to hold the needles and the guide in place and the tube in the rectum is removed The patient is the transferred from the MR scanner into the CT scanner where the rectal tube is reinserted and the needles are adjusted A cystoscopy is done to make sure the needles do not enter the bladder When the needles are adjusted the tube is removed from the rectum and the patient is moved to the radiation oncology clinic
After a few hours when the radiation dose has been calculated a radioactive substance called iridium is administered The needles placed in the prostate are connected to a radiation machine and thin wires with radioactive material on the tips are inserted into each needle and withdrawn a little at a time The process takes about 20 to 30 minutes The patient is then disconnected from the machine and undergoes another MRI scan to confirm the position of the needles The needles and catheter are then removed and the patient is monitored for a while before going home Patients then have 5 weeks of external beam therapy followed by a second brachytherapy treatment
Patients return to the clinic at 1 3 6 12 18 24 36 48 and 60 months after treatment for blood tests physical examination and review of symptoms
Patients 18 years of age and older with prostate cancer that has not spread to the bone may be eligible for this study Candidates will be screened with a physical examination blood and urine tests and a bone scan
To plan for radiation therapy patients will have standard computed tomography CT and MRI scans of the pelvis and prostate In addition CT and MRI scans will be done to determine if the prostate is in a good position for brachytherapy For these scans patients will have an enema and a tube will be placed in the rectum They will then lie still on their side for about 45 minutes during the scan Patients who have blood in their urine will also undergo cystoscopy This is an examination of the bladder using a small camera that is advanced through the penis into the bladder
Patients are given an antibiotic for 2 days before the brachytherapy and on the morning of the procedure Before the test they have a small enema and are given medicines through the vein and into the spine for relaxation and to decrease any discomfort The test is done under general anesthesia for patients who require it The patient is moved on a stretcher into the MRI scanner and a catheter is inserted into the bladder through the penis The bladder is filled with water and a tube is placed in the rectum With the help of a plastic guide placed against the skin about 14 to 18 needles are then placed in the prostate Some stitches are sewn to hold the needles and the guide in place and the tube in the rectum is removed The patient is the transferred from the MR scanner into the CT scanner where the rectal tube is reinserted and the needles are adjusted A cystoscopy is done to make sure the needles do not enter the bladder When the needles are adjusted the tube is removed from the rectum and the patient is moved to the radiation oncology clinic
After a few hours when the radiation dose has been calculated a radioactive substance called iridium is administered The needles placed in the prostate are connected to a radiation machine and thin wires with radioactive material on the tips are inserted into each needle and withdrawn a little at a time The process takes about 20 to 30 minutes The patient is then disconnected from the machine and undergoes another MRI scan to confirm the position of the needles The needles and catheter are then removed and the patient is monitored for a while before going home Patients then have 5 weeks of external beam therapy followed by a second brachytherapy treatment
Patients return to the clinic at 1 3 6 12 18 24 36 48 and 60 months after treatment for blood tests physical examination and review of symptoms
Detailed Description:
BACKGROUND
Brachytherapy the placement of a radioactive source close to a tumor is rapidly becoming an important modality for patients with prostate cancer because higher and more conformal doses can be safely delivered compared with external beam radiotherapy
High dose rate HDR temporary implants offer several treatment and research based advantages over permanent seeds including exceptionally complex and accurate dosimetry in reference to anatomic images
Needle placement in brachytherapy procedures requires detailed image guidance traditionally obtained with trans-rectal ultrasound TRUS MRI offers a 3D dataset arbitrary imaging planes and unparalleled soft tissue resolution of the anatomy making it the modality of choice for imaging the prostate gland
A real-time MR-guided prostate permanent seed implant technique that utilizes both real-time MRI and real-time dosimetry has been designed implemented and reported Results confirm that TRUS-guided implants may be improved upon by using MRI To our knowledge HDR implants have not yet been performed under MR guidance in a closed bore magnet
OBJECTIVES
The primary objective is to determine the quality of prostate HDR brachytherapy implants performed under MR-guidance
Quality is defined by the percentage of the planning target volume PTV encompassed by a given percentage of the prescribed dose In this study an implant will be of acceptable quality if 80 of the PTV is encompassed by the 100 isodose V100 80 in accordance with RTOG guidelines
ELIGIBILITY
Pathologically confirmed prostate cancer with the following features
Gleason score greater than 6 or greater than T2a or
PSA greater than or equal to 10 and no evidence of bone metastases
Age greater than or equal to 18 years
ECOG performance status of 0 or 1
DESIGN
The study is designed with a run-in pilot phase with the objective of refining the technique
The evaluation phase is a two-stage optimal design to evaluate the quality of the implant with an early look for futility
This study has the potential to enroll a maximum of 27 patients
Radiation treatment parameters will be patterned after established guidelines in the literature such as those reported by the American Brachytherapy Society and the William-Beaumont Hospital There will be no attempted dose escalation or attempts to prescribe the dose to unconventional target volumes in this phase of the project
Brachytherapy the placement of a radioactive source close to a tumor is rapidly becoming an important modality for patients with prostate cancer because higher and more conformal doses can be safely delivered compared with external beam radiotherapy
High dose rate HDR temporary implants offer several treatment and research based advantages over permanent seeds including exceptionally complex and accurate dosimetry in reference to anatomic images
Needle placement in brachytherapy procedures requires detailed image guidance traditionally obtained with trans-rectal ultrasound TRUS MRI offers a 3D dataset arbitrary imaging planes and unparalleled soft tissue resolution of the anatomy making it the modality of choice for imaging the prostate gland
A real-time MR-guided prostate permanent seed implant technique that utilizes both real-time MRI and real-time dosimetry has been designed implemented and reported Results confirm that TRUS-guided implants may be improved upon by using MRI To our knowledge HDR implants have not yet been performed under MR guidance in a closed bore magnet
OBJECTIVES
The primary objective is to determine the quality of prostate HDR brachytherapy implants performed under MR-guidance
Quality is defined by the percentage of the planning target volume PTV encompassed by a given percentage of the prescribed dose In this study an implant will be of acceptable quality if 80 of the PTV is encompassed by the 100 isodose V100 80 in accordance with RTOG guidelines
ELIGIBILITY
Pathologically confirmed prostate cancer with the following features
Gleason score greater than 6 or greater than T2a or
PSA greater than or equal to 10 and no evidence of bone metastases
Age greater than or equal to 18 years
ECOG performance status of 0 or 1
DESIGN
The study is designed with a run-in pilot phase with the objective of refining the technique
The evaluation phase is a two-stage optimal design to evaluate the quality of the implant with an early look for futility
This study has the potential to enroll a maximum of 27 patients
Radiation treatment parameters will be patterned after established guidelines in the literature such as those reported by the American Brachytherapy Society and the William-Beaumont Hospital There will be no attempted dose escalation or attempts to prescribe the dose to unconventional target volumes in this phase of the project
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 |
|---|---|---|---|
| 02-C-0207 | None | None | None |