Ignite Creation Date:
2024-05-05 @ 5:12 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00407875
Status:
UNKNOWN
Last Update Posted:
2018-07-13
First Post:
2006-12-01
Brief Title:
Intensity Modulated Versus Interstitial - Radiation Therapy
Sponsor:
British Columbia Cancer Agency
Organization:
British Columbia Cancer Agency
Study Overview
Official Title:
A Randomized Phase II Study Comparing Intensity Modulated External Beam Radiation Therapy IMRT Versus Permanent Interstitial Prostate Brachytherapy PIPB for Low Risk and Low-tier Intermediate Risk Prostate Cancer
Status:
UNKNOWN
Status Verified Date:
2018-07
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
Purpose
The purpose of this trial is to compare two different treatment options for patients with low risk and low-tier intermediate risk prostate cancer The two treatment arms being compared in this study are control arm permanent interstitial prostate brachytherapy PIPB VERSUS experimental arm intensity modulated external beam radiation therapy IMRT
Hypothesis
The acute and late toxicities experienced by patients in the experimental arm IMRT are not significantly worse then the toxicities experienced by patients in the control arm PIPB
The purpose of this trial is to compare two different treatment options for patients with low risk and low-tier intermediate risk prostate cancer The two treatment arms being compared in this study are control arm permanent interstitial prostate brachytherapy PIPB VERSUS experimental arm intensity modulated external beam radiation therapy IMRT
Hypothesis
The acute and late toxicities experienced by patients in the experimental arm IMRT are not significantly worse then the toxicities experienced by patients in the control arm PIPB
Detailed Description:
Justification
Patients with low risk and low-tier intermediate risk prostate cancer have a number of different standard treatment options to chose from that include a radical prostatectomy conventional external beam radiotherapy EBRT or permanent interstitial prostate brachytherapy PIPB Each of these treatment options have good outcomes although they are known to have a small risk of complications associated with each of them Unfortunately these treatment options have never been directly compared and therefore it is difficult to determine how these treatment options compare with respect to overall outcomes and toxicity
A recent analysis from the BC Cancer Agency suggested that patients treated with conventional EBRT within the Agency had inferior outcomes compared to PIPB This data as well as other indirect evidence suggest that conventional EBRT may be a suboptimal treatment option compared to PIPB Intensity modulated external beam radiotherapy IMRT is a new technology that allows for the delivery of high doses of radiation that tightly conforms to the target and limits the dose to surrounding critical structures Although IMRT is currently a standard therapeutic option that is utilized in other cancer sites at the BC Cancer Agency it has not been utilized in prostate cancer yet Recent evidence has confirmed that this experimental therapy is able to allow for the safe escalation of dose for prostate cancer patients which may lead to improved outcomes without increasing toxicity There is no current evidence that side effects and complication risks associated with IMRT are associated with any serious risk of increased toxicity although this continues to be studied
This study will compare this new therapeutic approach IMRT directly with a standard treatment option for prostate cancer patients PIPB This trial will allow us to determine how the toxicities of these treatments compare with each other and if successful will potentially lead to a larger study which will analyse how the outcomes of these therapeutic interventions compare We hope that this trial will make an important contribution to the care and future management of patients with prostate cancer
Objectives
Primary Objective
The primary end point of this study is the acute and late toxicities of the therapeutic interventions
Secondary Objectives
This trial is also intended to determine
The willingness of eligible patients to be randomized to the treatment interventions
Obstacles to accrual that need to be addressed
Testing our ability to meet accrual targets
Checking quality assurance benchmarks for IMRT and PIPB procedures
Discovering and relieving bottlenecks in IMRT planning and procedures
Quality of life
Pathological local control
Biochemical relapse-free survival
Metastasis-free survival
Overall survival
Research Method
The patients will be randomly assigned with equal probability to one of two treatment arms
Arm 1 Control Arm - Permanent interstitial prostate brachytherapy PIPB Arm 2 Experimental Arm - Intensity modulated external beam radiation therapy IMRT
Statistical Analysis
Primary Endpoints
Acute GI grade 3 or higher toxicity Acute GU grade 3 or higher toxicity Late GI grade 3 or higher toxicity Late GU grade 3 or higher toxicity
Secondary Endpoints
All acute and late toxicities Quality of life scores Using the expanded prostate cancer index composite - EPIC
Pathological local control Biochemical relapse-free survival using Phoenix definition Metastasis-free survival Overall survival
Planned sample size 50 patients in total ie 25 patients in each treatment arm
Statistical analysis
The two groups will be compared with respect to their primary and secondary endpoints Appropriate statistical analysis using a student t test for a statistical difference in crude rates of grade 3 or higher toxicity between the two treatment arms will be performed All endpoints will be analysed for crude event rates with 95 confidence intervals for each group
With a sample size of only 50 patients this trial is not powered to detect differences in the incidence of common self-limited side effects and adverse reactions compared to standard therapy For this reason the trials limited power is augmented by a Trial Safety Committee TSC which is bound by rules that require suspension termination of trial accrual in the event of major complications See Section 83 of Data Monitoring - Human Ethics Application for Clinical Study or Part I Section 53 on page 11 of the protocol
Patients with low risk and low-tier intermediate risk prostate cancer have a number of different standard treatment options to chose from that include a radical prostatectomy conventional external beam radiotherapy EBRT or permanent interstitial prostate brachytherapy PIPB Each of these treatment options have good outcomes although they are known to have a small risk of complications associated with each of them Unfortunately these treatment options have never been directly compared and therefore it is difficult to determine how these treatment options compare with respect to overall outcomes and toxicity
A recent analysis from the BC Cancer Agency suggested that patients treated with conventional EBRT within the Agency had inferior outcomes compared to PIPB This data as well as other indirect evidence suggest that conventional EBRT may be a suboptimal treatment option compared to PIPB Intensity modulated external beam radiotherapy IMRT is a new technology that allows for the delivery of high doses of radiation that tightly conforms to the target and limits the dose to surrounding critical structures Although IMRT is currently a standard therapeutic option that is utilized in other cancer sites at the BC Cancer Agency it has not been utilized in prostate cancer yet Recent evidence has confirmed that this experimental therapy is able to allow for the safe escalation of dose for prostate cancer patients which may lead to improved outcomes without increasing toxicity There is no current evidence that side effects and complication risks associated with IMRT are associated with any serious risk of increased toxicity although this continues to be studied
This study will compare this new therapeutic approach IMRT directly with a standard treatment option for prostate cancer patients PIPB This trial will allow us to determine how the toxicities of these treatments compare with each other and if successful will potentially lead to a larger study which will analyse how the outcomes of these therapeutic interventions compare We hope that this trial will make an important contribution to the care and future management of patients with prostate cancer
Objectives
Primary Objective
The primary end point of this study is the acute and late toxicities of the therapeutic interventions
Secondary Objectives
This trial is also intended to determine
The willingness of eligible patients to be randomized to the treatment interventions
Obstacles to accrual that need to be addressed
Testing our ability to meet accrual targets
Checking quality assurance benchmarks for IMRT and PIPB procedures
Discovering and relieving bottlenecks in IMRT planning and procedures
Quality of life
Pathological local control
Biochemical relapse-free survival
Metastasis-free survival
Overall survival
Research Method
The patients will be randomly assigned with equal probability to one of two treatment arms
Arm 1 Control Arm - Permanent interstitial prostate brachytherapy PIPB Arm 2 Experimental Arm - Intensity modulated external beam radiation therapy IMRT
Statistical Analysis
Primary Endpoints
Acute GI grade 3 or higher toxicity Acute GU grade 3 or higher toxicity Late GI grade 3 or higher toxicity Late GU grade 3 or higher toxicity
Secondary Endpoints
All acute and late toxicities Quality of life scores Using the expanded prostate cancer index composite - EPIC
Pathological local control Biochemical relapse-free survival using Phoenix definition Metastasis-free survival Overall survival
Planned sample size 50 patients in total ie 25 patients in each treatment arm
Statistical analysis
The two groups will be compared with respect to their primary and secondary endpoints Appropriate statistical analysis using a student t test for a statistical difference in crude rates of grade 3 or higher toxicity between the two treatment arms will be performed All endpoints will be analysed for crude event rates with 95 confidence intervals for each group
With a sample size of only 50 patients this trial is not powered to detect differences in the incidence of common self-limited side effects and adverse reactions compared to standard therapy For this reason the trials limited power is augmented by a Trial Safety Committee TSC which is bound by rules that require suspension termination of trial accrual in the event of major complications See Section 83 of Data Monitoring - Human Ethics Application for Clinical Study or Part I Section 53 on page 11 of the protocol
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