Ignite Creation Date:
2024-05-05 @ 5:17 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00426959
Status:
COMPLETED
Last Update Posted:
2012-11-14
First Post:
2007-01-24
Brief Title:
Study of Image-guided Dosimetry for Interstitial Prostate Brachytherapy
Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Organization:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Overview
Official Title:
Feasibility Study of Image-guided Dynamic Dosimetry for Permanent Interstitial Prostate Brachytherapy
Status:
COMPLETED
Status Verified Date:
2012-11
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 will be a phase I study This phase I study is not a standard drug dose escalation study but rather a Clinical System Performance Evaluation Trial of a therapeutic device However for purposes of this protocol we will refer to this portion of the trial as a phase I study
The purpose of this study is to demonstrate the feasibility and clinical practicability of the registered ultrasound and fluoroscopy RUF in combination with CMS Interplant system in an initial cohort of 6 patients
This will involve demonstrating the feasibility of using the system in an actual operating room environment as well as obtaining a preliminary assessment of the accuracy and performance of the source location algorithm by comparing with postoperative CT dosimetry
The Primary endpoint of this study will be evaluation of the feasibility of using the RUF system and of performing real-time optimization in the operating room environment
The Secondary endpoints of this study will be
1 Acute and late toxicity as assessed by IPSS SHIM and EPIC questionnaires at multiple follow-up intervals
2 PSA-free survival
Study Population
The target population will be patients with a diagnosis of adenocarcinoma of the prostate who are seen in consultation at the Johns Hopkins Hospital
Approximately 360 patients per year with the diagnosis of prostate cancer are seen in the Department of Radiation Oncology at Johns Hopkins Hospital Of these patients approximately 45 have low-risk T1a-T2a Gleason 6 or less PSA 10 ngml or less or intermediate-risk disease and are suitable for brachytherapy based on disease risk Within this group of patients approximately 70 are eligible for brachytherapy based on gland size and no prior transurethral resection of prostate TURP
Approximately 80 of patients offered brachytherapy at consultation decide to receive their treatment at Johns Hopkins Overall we currently perform 2 brachytherapy procedures per week on average for a yearly total of approximately 90 cases
For purposes of homogeneity of treatment and patient population this protocol will only enroll patients currently treated at this institution with brachytherapy alone and will not enroll patients intermediate or high risk disease who will require external beam radiation in addition to brachytherapy
The purpose of this study is to demonstrate the feasibility and clinical practicability of the registered ultrasound and fluoroscopy RUF in combination with CMS Interplant system in an initial cohort of 6 patients
This will involve demonstrating the feasibility of using the system in an actual operating room environment as well as obtaining a preliminary assessment of the accuracy and performance of the source location algorithm by comparing with postoperative CT dosimetry
The Primary endpoint of this study will be evaluation of the feasibility of using the RUF system and of performing real-time optimization in the operating room environment
The Secondary endpoints of this study will be
1 Acute and late toxicity as assessed by IPSS SHIM and EPIC questionnaires at multiple follow-up intervals
2 PSA-free survival
Study Population
The target population will be patients with a diagnosis of adenocarcinoma of the prostate who are seen in consultation at the Johns Hopkins Hospital
Approximately 360 patients per year with the diagnosis of prostate cancer are seen in the Department of Radiation Oncology at Johns Hopkins Hospital Of these patients approximately 45 have low-risk T1a-T2a Gleason 6 or less PSA 10 ngml or less or intermediate-risk disease and are suitable for brachytherapy based on disease risk Within this group of patients approximately 70 are eligible for brachytherapy based on gland size and no prior transurethral resection of prostate TURP
Approximately 80 of patients offered brachytherapy at consultation decide to receive their treatment at Johns Hopkins Overall we currently perform 2 brachytherapy procedures per week on average for a yearly total of approximately 90 cases
For purposes of homogeneity of treatment and patient population this protocol will only enroll patients currently treated at this institution with brachytherapy alone and will not enroll patients intermediate or high risk disease who will require external beam radiation in addition to brachytherapy
Detailed Description:
This will be a prospective Phase I study
Subject Identification Patient confidentiality will be maintained in accordance with Health Information Portability and Accountability Act HIPAA guidelines
All participants must sign an informed consent that will describe the objectives of the study and potential risks All patient data reported on the case reports forms will be identified by the patients initials and study code number onlyPatients shall not be identified by name This should serve to protect the confidentiality of subjects enrolled on the trial Clinical data and records for all subjects studied including history and physical findings laboratory data and results of interventions are to be maintained by the investigators in a secure locked location Computerized data will require password authorizations for access
Description of the Recruitment Process
Potential subjects will be identified at the time of consultation in the Department of Radiation Oncology by Dr Song or Dr DeWeese If Dr DeWeese identifies a potential patient during a consult he will refer them to Dr Song so that Dr Song can offer the patient the opportunity to participate Dr DeWeese will not offer patients the opportunity to participate but will only assist in identifying potential patients for the research team as he sees many brachytherapy cases during his consultations
Description of the Informed Consent Process
Only the principal investigator and those listed as co-investigators will perform the informed consent interview The informed consent interview will take place before the patient is to be treated to ensure that the patient has adequate time to discuss the research project with family friends andor other Health Care providers During the informed consent interview the interviewer investigator will take as much time as needed to ensure that the potential subject understands the research project and also clearly understands that he does not have to participate in this project to receive his cancer treatment at Johns Hopkins If the patient decides to enroll into the research project he will sign three copies of the informed consent form One will be for his own recordsone will be kept in the Clinical Research Office at Johns Hopkins and the third one will be kept in his medical records
Subject Assignment
6 patients will be enrolled onto the trial The patients will have their brachytherapy planned using a registered ultrasound and fluoroscopy RUF in combination with the CMS Interplant system
Screening Procedures for Standard Brachytherapy
History and physical and KPS at the time of consultation
Volume of the prostate based on ultrasound at the time of diagnostic biopsy If this is not available then patient will have prostatic volume estimated by digital rectal examination at time of consultation and confirmatory ultrasound performed in the clinic
Tumors are to be graded and Gleason score provided on the pathology report
Prostate specific antigen PSA
CT scan of the pelvis Nodes evaluated negative by imaging methods will be classified as NXOnly nodes evaluated negative by surgical sampling will be classified as N0
Bone scan is optional given the low risk of positive findings in this population
IPSS Symptom Score at the time of consultation
Clinical Assessments
Once informed consent has been obtained the following assessments will be performed on the subject
Pre-Treatment Evaluation to be performed within 6 weeks prior to day 1 of brachytherapy i History and Physical ii IPSS SHIM and EPIC questionnaires See Appendix 1 for questionnaires iii Serum PSA iv Chest X-Ray v Bone Scan if clinically indicated vi CT of pelvis vii Ultrasound volume to be done 4 weeks to 4 days prior to day 1 of brachytherapy
Day 1 of Brachytherapy
i Chest X-Ray ii CT of the Pelvis
These studies can be done the day after Brachytherapy
Day 30 30 days - 7 days from Brachytherapy
i History and Physical ii IPSS SHIM EPIC questionnaires iii Serum PSA iv CT of the Pelvis v Chest X-Ray
Month 3 3 months - 2 weeks from Brachytherapy
i History and Physical ii IPSS SHIM EPIC questionnaires iii Serum PSA iv Chest X-Ray
Month 6 6 months - 4 weeks from Brachytherapy
i History and Physical ii IPSS SHIM EPIC questionnaires iii Serum PSA
Month 9 9 months - 4 weeks from Brachytherapy
i History and Physical ii IPSS SHIM EPIC questionnaires iii Serum PSA
Month 12 12 months - 4 weeks from Brachytherapy
i History and Physical ii IPSS SHIM EPIC questionnaires iii Serum PSA
Post 12 month follow-up patients will be followed for an additional two more years Note In years 2 and 3 patients will be followed on a semiannual basis and will have the following assessments performed i History and Physical ii IPSS SHIM EPIC questionnaires iii Serum PSA Version 4 07112006 9
Data to be Collected
The data that will be collected for this trial will be the results andor findings of the procedures and assessments that are previously outlined R
Resultsfindings will be abstracted from the source documents eg physician notes nursing notes radiology reports lab reports etc and recorded onto study specific case report forms Only medical records that have been validated by the provider will be used as source documents for data collection The data manager assigned to this trial will be responsible for the data collection HeShe will have access to patient medical records and will record medical information from the medical record onto the case report form The principal investigator will review the data on a monthly basis for accuracy
Research Interventions
RADIATION THERAPY AND RESEARCH INTERVENTIONS
The patient population who will be offered this protocol are those who are currently offered brachytherapy as standard treatment at our institution Patients will experience no change in the procedure other than an approximately 10 increase in the duration of fluoroscopy on time during the procedure There will also be one additional CT scan post-implant to assess dosimetry at Day 30 This is necessary to account for the effects of post-implant edema on the dosimetric parameters and source positions measurements
Implant Volumes
The target volume definitions are for the most part based upon the ICRU Report 58 Dose and Volume Specification for Reporting Interstitial Therapy
Clinical Target Volume CTV Pre-implant TRUS definition of the prostate
Planning Target Volume PTV An enlargement of the CTV as follows
1 Expand the TRUS definition of the prostate by 3 mm in the lateral dimension for each TRUS axial image Thus the lateral dimension of the prostate will increase by approximately 6 mm
2 Expand the TRUS definition of the prostate by 3 mm in the anterior dimension for each TRUS axial image
3 Maintain the same posterior border of the prostate as defined by TRUS
4 Project the expanded most cephalad axial definition to a plane 3 mm cephalad to the cephalad most TRUS plane
5 Project the expanded most caudad axial definition to a plane 3 mm caudad to the caudad most TRUS plane The PTV is approximately 6 mm longer in the caudad-cephalad dimension than the CTV
Evaluation Target Volume ETV
The ETV is defined as the post-implant CT definition of the prostate
Subject Identification Patient confidentiality will be maintained in accordance with Health Information Portability and Accountability Act HIPAA guidelines
All participants must sign an informed consent that will describe the objectives of the study and potential risks All patient data reported on the case reports forms will be identified by the patients initials and study code number onlyPatients shall not be identified by name This should serve to protect the confidentiality of subjects enrolled on the trial Clinical data and records for all subjects studied including history and physical findings laboratory data and results of interventions are to be maintained by the investigators in a secure locked location Computerized data will require password authorizations for access
Description of the Recruitment Process
Potential subjects will be identified at the time of consultation in the Department of Radiation Oncology by Dr Song or Dr DeWeese If Dr DeWeese identifies a potential patient during a consult he will refer them to Dr Song so that Dr Song can offer the patient the opportunity to participate Dr DeWeese will not offer patients the opportunity to participate but will only assist in identifying potential patients for the research team as he sees many brachytherapy cases during his consultations
Description of the Informed Consent Process
Only the principal investigator and those listed as co-investigators will perform the informed consent interview The informed consent interview will take place before the patient is to be treated to ensure that the patient has adequate time to discuss the research project with family friends andor other Health Care providers During the informed consent interview the interviewer investigator will take as much time as needed to ensure that the potential subject understands the research project and also clearly understands that he does not have to participate in this project to receive his cancer treatment at Johns Hopkins If the patient decides to enroll into the research project he will sign three copies of the informed consent form One will be for his own recordsone will be kept in the Clinical Research Office at Johns Hopkins and the third one will be kept in his medical records
Subject Assignment
6 patients will be enrolled onto the trial The patients will have their brachytherapy planned using a registered ultrasound and fluoroscopy RUF in combination with the CMS Interplant system
Screening Procedures for Standard Brachytherapy
History and physical and KPS at the time of consultation
Volume of the prostate based on ultrasound at the time of diagnostic biopsy If this is not available then patient will have prostatic volume estimated by digital rectal examination at time of consultation and confirmatory ultrasound performed in the clinic
Tumors are to be graded and Gleason score provided on the pathology report
Prostate specific antigen PSA
CT scan of the pelvis Nodes evaluated negative by imaging methods will be classified as NXOnly nodes evaluated negative by surgical sampling will be classified as N0
Bone scan is optional given the low risk of positive findings in this population
IPSS Symptom Score at the time of consultation
Clinical Assessments
Once informed consent has been obtained the following assessments will be performed on the subject
Pre-Treatment Evaluation to be performed within 6 weeks prior to day 1 of brachytherapy i History and Physical ii IPSS SHIM and EPIC questionnaires See Appendix 1 for questionnaires iii Serum PSA iv Chest X-Ray v Bone Scan if clinically indicated vi CT of pelvis vii Ultrasound volume to be done 4 weeks to 4 days prior to day 1 of brachytherapy
Day 1 of Brachytherapy
i Chest X-Ray ii CT of the Pelvis
These studies can be done the day after Brachytherapy
Day 30 30 days - 7 days from Brachytherapy
i History and Physical ii IPSS SHIM EPIC questionnaires iii Serum PSA iv CT of the Pelvis v Chest X-Ray
Month 3 3 months - 2 weeks from Brachytherapy
i History and Physical ii IPSS SHIM EPIC questionnaires iii Serum PSA iv Chest X-Ray
Month 6 6 months - 4 weeks from Brachytherapy
i History and Physical ii IPSS SHIM EPIC questionnaires iii Serum PSA
Month 9 9 months - 4 weeks from Brachytherapy
i History and Physical ii IPSS SHIM EPIC questionnaires iii Serum PSA
Month 12 12 months - 4 weeks from Brachytherapy
i History and Physical ii IPSS SHIM EPIC questionnaires iii Serum PSA
Post 12 month follow-up patients will be followed for an additional two more years Note In years 2 and 3 patients will be followed on a semiannual basis and will have the following assessments performed i History and Physical ii IPSS SHIM EPIC questionnaires iii Serum PSA Version 4 07112006 9
Data to be Collected
The data that will be collected for this trial will be the results andor findings of the procedures and assessments that are previously outlined R
Resultsfindings will be abstracted from the source documents eg physician notes nursing notes radiology reports lab reports etc and recorded onto study specific case report forms Only medical records that have been validated by the provider will be used as source documents for data collection The data manager assigned to this trial will be responsible for the data collection HeShe will have access to patient medical records and will record medical information from the medical record onto the case report form The principal investigator will review the data on a monthly basis for accuracy
Research Interventions
RADIATION THERAPY AND RESEARCH INTERVENTIONS
The patient population who will be offered this protocol are those who are currently offered brachytherapy as standard treatment at our institution Patients will experience no change in the procedure other than an approximately 10 increase in the duration of fluoroscopy on time during the procedure There will also be one additional CT scan post-implant to assess dosimetry at Day 30 This is necessary to account for the effects of post-implant edema on the dosimetric parameters and source positions measurements
Implant Volumes
The target volume definitions are for the most part based upon the ICRU Report 58 Dose and Volume Specification for Reporting Interstitial Therapy
Clinical Target Volume CTV Pre-implant TRUS definition of the prostate
Planning Target Volume PTV An enlargement of the CTV as follows
1 Expand the TRUS definition of the prostate by 3 mm in the lateral dimension for each TRUS axial image Thus the lateral dimension of the prostate will increase by approximately 6 mm
2 Expand the TRUS definition of the prostate by 3 mm in the anterior dimension for each TRUS axial image
3 Maintain the same posterior border of the prostate as defined by TRUS
4 Project the expanded most cephalad axial definition to a plane 3 mm cephalad to the cephalad most TRUS plane
5 Project the expanded most caudad axial definition to a plane 3 mm caudad to the caudad most TRUS plane The PTV is approximately 6 mm longer in the caudad-cephalad dimension than the CTV
Evaluation Target Volume ETV
The ETV is defined as the post-implant CT definition of the prostate
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