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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 3, 2018
Sponsor:
Information provided by (Responsible Party):
Andrew Loblaw, Sunnybrook Health Sciences Centre

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Radiation: MRI assisted focal boost with HDR monotherapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: MRI Assisted Focal Boost Integrated With HDR Monotherapy Study in Low and Intermediate Risk Prostate Cancer Patients (MARS)
Actual Study Start Date : September 2015
Actual Primary Completion Date : February 2017
Estimated Study Completion Date : February 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
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
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




Primary Outcome Measures :
  1. Acute GU and GI toxicities [ Time Frame: 3mo ]
    Measured according to NCI CTCAE v4.0


Secondary Outcome Measures :
  1. Late GU and GI toxicities [ Time Frame: 5 years ]
    Measured according to NCI CTCAE v4.0

  2. Quality of life changes [ Time Frame: 5 years ]
    Patient reported outcome utilizing Expanded Prostate Index Composite (EPIC)

  3. Changes in urinary symptoms [ Time Frame: 5 years ]
    Patient reported outcome utilizing International Prostate Symptom Score (IPSS)

  4. Changes in serum prostate-specific antigen (PSA) [ Time Frame: 5 years ]
  5. PSA failure and disease-free survival rates [ Time Frame: 5 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02623933


Locations
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Canada, Ontario
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Investigators
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Principal Investigator: Andrew Loblaw, MD Sunnybrook Health Sciences Centre

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Responsible Party: Andrew Loblaw, Dr Andrew Loblaw, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT02623933     History of Changes
Other Study ID Numbers: MARS 222-2015
First Posted: December 8, 2015    Key Record Dates
Last Update Posted: July 3, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Andrew Loblaw, Sunnybrook Health Sciences Centre:
HDR monotherapy
MRI guidance
Intraprostatic lesion
dose paining

Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases