MRI Assisted Focal Boost With HDR Monotherapy for Prostate Cancer Patients (MARS)
Primary Purpose
Prostate Cancer
Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
MRI assisted focal boost with HDR monotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring HDR monotherapy, MRI guidance, Intraprostatic lesion, dose paining
Eligibility Criteria
Inclusion Criteria:
- Histologically confirmed diagnosis of adenocarcinoma of the prostate
- Low and Intermediate risk disease defined as T1-T2c, Gleason < 7 and PSA < 20 ng/ml.
- Prostate volume < 60 cc as determined by US, CT or MRI
- Ability to undergo MR imaging
- Provide written informed consent
- Identified MR nodule (PIRADs 4/5)
Exclusion Criteria:
- Ineligible for MR imaging due to contraindications
- Documented nodal or distant metastases
- Previous pelvic radiotherapy
- Previous trans-urethral resection of prostate, previous prostatectomy or HIFU
- Use of androgen deprivation therapy. Use of 5-alpha-reductase inhibitors permitted
- Poor baseline urinary function defined as International Prostate Symptom Score (IPSS) >15
- Contra-indication to radical prostate radiotherapy e.g. connective tissue disease or inflammatory bowel disease
- Significant medical co-morbidity rendering patient unsuitable for general anaesthetic
Sites / Locations
- Sunnybrook Health Sciences Centre
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
MRI assisted HDR monotherapy
Arm Description
HDR monotherapy to the whole prostate gland (19Gy/1) with MRI assisted focal boost to intraprostatic nodule up to 22.5Gy
Outcomes
Primary Outcome Measures
Acute GU and GI toxicities
Measured according to NCI CTCAE v4.0
Secondary Outcome Measures
Late GU and GI toxicities
Measured according to NCI CTCAE v4.0
Quality of life changes
Patient reported outcome utilizing Expanded Prostate Index Composite (EPIC)
Changes in urinary symptoms
Patient reported outcome utilizing International Prostate Symptom Score (IPSS)
Changes in serum prostate-specific antigen (PSA)
PSA failure and disease-free survival rates
Full Information
NCT ID
NCT02623933
First Posted
December 3, 2015
Last Updated
June 12, 2022
Sponsor
Sunnybrook Health Sciences Centre
1. Study Identification
Unique Protocol Identification Number
NCT02623933
Brief Title
MRI Assisted Focal Boost With HDR Monotherapy for Prostate Cancer Patients
Acronym
MARS
Official Title
MRI Assisted Focal Boost Integrated With HDR Monotherapy Study in Low and Intermediate Risk Prostate Cancer Patients (MARS)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 24, 2015 (Actual)
Primary Completion Date
May 30, 2017 (Actual)
Study Completion Date
May 13, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sunnybrook Health Sciences Centre
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Radiation therapy plays an important role in the management of prostate cancer. In recent years it has become evident that higher doses of radiation are required to optimize disease control. The limiting factor of escalating dose to the prostate is the surrounding normal tissue. Despite advances in escalating radiation therapy, failures still occur in 20-30% of patients most often at the site of the original primary disease. As such there is growing interest in further dose escalating to the area of primary disease burden.The aim of this work is to look at the feasibility and toxicities of an integrated focal boost to whole gland prostate treatment using high dose rate brachytherapy.
Detailed Description
This study is a pilot study of 60 patients look at the toxicities, biochemical and patient reported quality of life outcomes of an MR-integrated focal boost using HDR prostate brachytherapy. Eligible patients for this study will be determined by pre-brachytherapy MRI (DCE, T2 weighted and diffusion weighted) imaging, to identify a dominant intraprostatic lesion. The HDR dose prescription is 19 Gy to the whole gland ad 22.5 Gy to MRI visible lesion delivered in one fraction, assuming that dose constraints to critical organs can be met.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
HDR monotherapy, MRI guidance, Intraprostatic lesion, dose paining
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MRI assisted HDR monotherapy
Arm Type
Experimental
Arm Description
HDR monotherapy to the whole prostate gland (19Gy/1) with MRI assisted focal boost to intraprostatic nodule up to 22.5Gy
Intervention Type
Radiation
Intervention Name(s)
MRI assisted focal boost with HDR monotherapy
Intervention Description
Prior to brachytherapy treatment, a multiparametric MRI will be obtained for identification of the dominant intraprostatic lesion (DIL) and fused with the preplanning transrectal ultrasound. A total of 19 Gy will be prescribed to the prostate, organ at risk limits will be observed and up to 22.5 Gy can be delivered to the DIL
Primary Outcome Measure Information:
Title
Acute GU and GI toxicities
Description
Measured according to NCI CTCAE v4.0
Time Frame
3mo
Secondary Outcome Measure Information:
Title
Late GU and GI toxicities
Description
Measured according to NCI CTCAE v4.0
Time Frame
5 years
Title
Quality of life changes
Description
Patient reported outcome utilizing Expanded Prostate Index Composite (EPIC)
Time Frame
5 years
Title
Changes in urinary symptoms
Description
Patient reported outcome utilizing International Prostate Symptom Score (IPSS)
Time Frame
5 years
Title
Changes in serum prostate-specific antigen (PSA)
Time Frame
5 years
Title
PSA failure and disease-free survival rates
Time Frame
5 years
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically confirmed diagnosis of adenocarcinoma of the prostate
Low and Intermediate risk disease defined as T1-T2c, Gleason < 7 and PSA < 20 ng/ml.
Prostate volume < 60 cc as determined by US, CT or MRI
Ability to undergo MR imaging
Provide written informed consent
Identified MR nodule (PIRADs 4/5)
Exclusion Criteria:
Ineligible for MR imaging due to contraindications
Documented nodal or distant metastases
Previous pelvic radiotherapy
Previous trans-urethral resection of prostate, previous prostatectomy or HIFU
Use of androgen deprivation therapy. Use of 5-alpha-reductase inhibitors permitted
Poor baseline urinary function defined as International Prostate Symptom Score (IPSS) >15
Contra-indication to radical prostate radiotherapy e.g. connective tissue disease or inflammatory bowel disease
Significant medical co-morbidity rendering patient unsuitable for general anaesthetic
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Loblaw, MD
Organizational Affiliation
Sunnybrook Health Sciences Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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MRI Assisted Focal Boost With HDR Monotherapy for Prostate Cancer Patients
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