MR-guided Tumour Boost

Prostate Cancer Clinical Trial

— MRL-Boost  

Official title:

MR-guided Tumour Boost With Stereotactic Body Radiotherapy in Prostate Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05364229
• Other study ID #: 21-6162
• Status: Recruiting
• Phase: N/A
• Start date: February 6, 2023
• Est. completion date: June 2030

Study information

• Verified date: March 2024
• Source: University Health Network, Toronto
• Contact: Peter Chung, MD
• Phone: 416-946-4501
• Email: peter.chung[@]uhn.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 2030
• Est. primary completion date: June 2030
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Radiation:
• 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.

Locations

Country	Name	City	State
Canada	University Health Network, Princess Margaret Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of MR-guided Linear Acceleratorfor tumour-targeted intra-prostatic dose escalation as boost	Total proportion of patients achieving predefined dosimetric parameters: PTV V100, PTV D90, Urethra V105, Rectum V75, Bladder V75	Baseline
Secondary	Acute Toxicity	Acute (less than or equal to 90 days) toxicity will be evaluated by using prospective follow-up and grading according to the latest version of the Common Terminology Criteria for Adverse Events (CTCAE) v5.0	Baseline to 5-year follow-up
Secondary	Late Toxicity	Late (more than 90 days) toxicity will be evaluated by using prospective follow-up and grading according to the latest version of the Common Terminology Criteria for Adverse Events (CTCAE) v5.0	Baseline to 5-year follow-up
Secondary	Patient-reported quality-of-life assessed by EPIC-26	Patient-Reported Quality of Life will be assessed at baseline and at each follow-up visit (1-, 3-, and 6-months post radiation as well as years 1, 2, 3, 4, and 5) using the following assessment questionnaires: 26-Item Expanded Prostate Cancer Index Composite (EPIC-26)	Baseline to 5-year follow-up