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Active Not RecruitingNCT02623933

MRI Assisted Focal Boost With HDR Monotherapy for Prostate Cancer Patients

MRI Assisted Focal Boost Integrated With HDR Monotherapy Study in Low and Intermediate Risk Prostate Cancer Patients (MARS)

Status
Active Not Recruiting
Phase
N/A
Study type
Interventional
Enrollment
60 (actual)
Sponsor
Sunnybrook Health Sciences Centre · Academic / Other
Sex
Male
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
RADIATIONMRI assisted focal boost with HDR monotherapyPrior 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

Timeline

Start date
2015-09-24
Primary completion
2017-05-30
Completion
2027-05-13
First posted
2015-12-08
Last updated
2022-06-14

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT02623933. Inclusion in this directory is not an endorsement.