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MRI Assisted Focal Boost With HDR Monotherapy for Prostate Cancer Patients (MARS)

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ClinicalTrials.gov Identifier: NCT02623933
Recruitment Status : Active, not recruiting
First Posted : December 8, 2015
Last Update Posted : July 19, 2019
Sponsor:
Information provided by (Responsible Party):
Andrew Loblaw, Sunnybrook Health Sciences Centre

Tracking Information
First Submitted Date  ICMJE December 3, 2015
First Posted Date  ICMJE December 8, 2015
Last Update Posted Date July 19, 2019
Actual Study Start Date  ICMJE September 24, 2015
Actual Primary Completion Date May 30, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 3, 2015)
Acute GU and GI toxicities [ Time Frame: 3mo ]
Measured according to NCI CTCAE v4.0
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02623933 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 3, 2015)
  • Late GU and GI toxicities [ Time Frame: 5 years ]
    Measured according to NCI CTCAE v4.0
  • Quality of life changes [ Time Frame: 5 years ]
    Patient reported outcome utilizing Expanded Prostate Index Composite (EPIC)
  • Changes in urinary symptoms [ Time Frame: 5 years ]
    Patient reported outcome utilizing International Prostate Symptom Score (IPSS)
  • Changes in serum prostate-specific antigen (PSA) [ Time Frame: 5 years ]
  • PSA failure and disease-free survival rates [ Time Frame: 5 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE MRI Assisted Focal Boost With HDR Monotherapy for Prostate Cancer Patients
Official Title  ICMJE MRI Assisted Focal Boost Integrated With HDR Monotherapy Study in Low and Intermediate Risk Prostate Cancer Patients (MARS)
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer
Intervention  ICMJE Radiation: MRI assisted focal boost with HDR monotherapy
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
Study Arms  ICMJE Experimental: MRI assisted HDR monotherapy
HDR monotherapy to the whole prostate gland (19Gy/1) with MRI assisted focal boost to intraprostatic nodule up to 22.5Gy
Intervention: Radiation: MRI assisted focal boost with HDR monotherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: October 31, 2016)
60
Original Estimated Enrollment  ICMJE
 (submitted: December 3, 2015)
30
Estimated Study Completion Date  ICMJE February 2022
Actual Primary Completion Date May 30, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Histologically confirmed diagnosis of adenocarcinoma of the prostate
  2. Low and Intermediate risk disease defined as T1-T2c, Gleason < 7 and PSA < 20 ng/ml.
  3. Prostate volume < 60 cc as determined by US, CT or MRI
  4. Ability to undergo MR imaging
  5. Provide written informed consent
  6. Identified MR nodule (PIRADs 4/5)

Exclusion Criteria:

  1. Ineligible for MR imaging due to contraindications
  2. Documented nodal or distant metastases
  3. Previous pelvic radiotherapy
  4. Previous trans-urethral resection of prostate, previous prostatectomy or HIFU
  5. Use of androgen deprivation therapy. Use of 5-alpha-reductase inhibitors permitted
  6. Poor baseline urinary function defined as International Prostate Symptom Score (IPSS) >15
  7. Contra-indication to radical prostate radiotherapy e.g. connective tissue disease or inflammatory bowel disease
  8. Significant medical co-morbidity rendering patient unsuitable for general anaesthetic
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02623933
Other Study ID Numbers  ICMJE MARS 222-2015
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Andrew Loblaw, Sunnybrook Health Sciences Centre
Study Sponsor  ICMJE Sunnybrook Health Sciences Centre
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Andrew Loblaw, MD Sunnybrook Health Sciences Centre
PRS Account Sunnybrook Health Sciences Centre
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP