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Radiation Therapy

MR-Guided Radiotherapy for Prostate Cancer (MRL-Boost Trial)

N/A
Recruiting
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
18 years of age or older
Planned for EBRT (+/- ADT)
Must not have
Ataxia Telangectasia and SLE
Prior radiotherapy to pelvis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 5-year follow-up
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new treatment for prostate cancer that involves MR-guided radiotherapy. 40 patients will be recruited and monitored for up to 5 years.

Who is the study for?
This trial is for men with localized prostate cancer confirmed by tissue analysis and MRI, who are categorized as low to high-risk but ideally have only one high-risk factor. They must be planning external beam radiation therapy (possibly with hormone therapy), able to perform daily activities (ECOG 0 or 1), at least 18 years old, and can consent to the study. Men with severe bowel diseases, claustrophobia, metastases, certain genetic conditions or prior pelvic radiotherapy cannot join.
What is being tested?
The study tests if giving an MR-guided radiotherapy boost directly to the tumor visible on MRI before or after whole gland radiation improves outcomes in prostate cancer patients. It's a single-arm feasibility study following participants for up to five years post-treatment.
What are the potential side effects?
While not explicitly listed here, potential side effects of MR-guided radiotherapy may include skin irritation at the treatment site, fatigue, urinary issues like increased frequency or discomfort during urination, and bowel problems such as diarrhea.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I am scheduled for external beam radiation therapy, with or without hormone therapy.
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My prostate cancer diagnosis was confirmed through a tissue examination.
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My prostate cancer is high-risk with one of the following: a stage above T2, PSA over 20, or Gleason score above 7.
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I am fully active or can carry out light work.
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My prostate cancer is considered low risk.
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My prostate cancer is at an intermediate stage with specific PSA levels or Gleason score.
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My prostate cancer is confirmed to be in less than one-third of my prostate.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have Ataxia Telangiectasia or Systemic Lupus Erythematosus.
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I have had radiation therapy to my pelvis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 5-year follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 5-year follow-up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Feasibility of MR-guided Linear Acceleratorfor tumour-targeted intra-prostatic dose escalation as boost
Secondary study objectives
Acute Toxicity
Late Toxicity
Patient-reported quality-of-life assessed by EPIC-26

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: MR-guided Tumour Boost with SBRTExperimental Treatment1 Intervention
MR-guided radiotherapy boost to MRI visible tumour

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor
1,531 Previous Clinical Trials
504,282 Total Patients Enrolled
65 Trials studying Prostate Cancer
15,552 Patients Enrolled for Prostate Cancer

Media Library

MR-guided Radiotherapy Boost (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05364229 — N/A
Prostate Cancer Research Study Groups: MR-guided Tumour Boost with SBRT
Prostate Cancer Clinical Trial 2023: MR-guided Radiotherapy Boost Highlights & Side Effects. Trial Name: NCT05364229 — N/A
MR-guided Radiotherapy Boost (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05364229 — N/A
~27 spots leftby Jun 2030
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