MR-guided Tumour Boost

NCT ID: NCT05364229

Last Updated: 2024-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-06

Study Completion Date

2030-06-30

Brief Summary

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This is a single-arm feasibility study that is recruiting 40 patients with histologically-proven localized prostate cancer and MRI-defined lesion(s). Participants in this study will get MR-guided radiotherapy boost to MRI visible tumour before or after whole gland radiation. Participants will be followed-up as per standard of care schedule up to 5 years post-treatment.

Detailed Description

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Conditions

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Prostate Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MR-guided Tumour Boost with SBRT

MR-guided radiotherapy boost to MRI visible tumour

Group Type EXPERIMENTAL

MR-guided Radiotherapy Boost

Intervention Type RADIATION

IMRT/VMAT prostate whole gland SBRT to 30 Gy in 5 fractions. MRL focal boost of 15 Gy in 1 fraction will be delivered either before or after whole gland SBRT.

Interventions

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MR-guided Radiotherapy Boost

IMRT/VMAT prostate whole gland SBRT to 30 Gy in 5 fractions. MRL focal boost of 15 Gy in 1 fraction will be delivered either before or after whole gland SBRT.

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

* Histologically-proven localized prostate cancer.
* Low, Intermediate, and High-risk prostate cancer (ideally limited to 1 risk factor)
* Low-risk: cT1-T2a, PSA \<10, and Gleason score 6
* Intermediate-risk: cT2b-c, PSA 10-20, and/or Gleason score 7
* High-risk limited to 1 risk factor: \>T2, PSA \>20, or Gleason score \>7
* Intra-prostatic tumour(s) demonstrated on mpMRI histologically confirmed limited to =/\< 1/3 total prostate volume
* Planned for EBRT (+/- ADT)
* ECOG 0 or 1
* 18 years of age or older
* Ability to provide written informed consent to participate in the study

Exclusion Criteria

* Prior radiotherapy to pelvis
* Radiological evidence of regional or distant metastases at the discretion of the treating physician.
* Active ulcerative colitis or Crohn's Disease, at discretion of treating physician
* Ataxia Telangectasia and SLE
* Contraindications to MRI; including patients with pacemakers/implantable cardiac defibrillator, cerebral aneurysm clips, shrapnel injury
* Severe claustrophobia
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University Health Network, Princess Margaret Hospital

Toronto, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Peter Chung, MD

Role: CONTACT

416-946-4501 ext. 6522

Facility Contacts

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Peter Chung, MB ChB

Role: primary

416 946 4501 ext. 6522

Other Identifiers

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21-6162

Identifier Type: -

Identifier Source: org_study_id

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