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Radiation Therapy

Prostate SBRT + Triptorelin for Prostate Cancer (DEFINE Trial)

Phase 2

Recruiting

Led By Scott C Morgan, MD, MSc

Research Sponsored by Ottawa Hospital Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥ 18 years

Unfavourable intermediate-risk or high-risk localized disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new approach to treating localized prostate cancer. Currently, patients receive daily radiotherapy sessions for four weeks. In this study, patients will receive fewer but larger sessions over one week.

Who is the study for?

Men with a specific type of prostate cancer that's not the mildest but also hasn't spread far (intermediate-risk or high-risk localized). They should have had an MRI within the last year, be able to do most activities without help (ECOG 0-2), and be at least 18 years old. They must agree to hormone therapy with triptorelin, possibly plus another drug.

What is being tested?

The trial is testing a new way of giving radiotherapy for prostate cancer. Instead of daily treatments for four weeks, patients get three big doses over one week. The radiation is aimed more precisely using MRI images to target just the tumor areas in hopes of lowering recurrence risk.

What are the potential side effects?

Possible side effects include urinary and bowel issues similar to those from standard radiotherapy. Since this method uses higher doses each time but fewer sessions overall, it's being checked if these side effects are worse than usual.

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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My condition is considered to be at a high risk of getting worse.

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My prostate cancer is high-risk due to its stage, Gleason score, or PSA level.

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I can take care of myself and am up and about more than half of the day.

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I have prostate cancer and am planning to undergo hormone therapy for up to 6 or 24 months.

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My prostate cancer was confirmed through a tissue examination.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Genitourinary and gastrointestinal toxicity

Secondary study objectives

Bowel and urinary quality of life

Disease-free survival

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: Prostate SBRT with Focal Boost and Androgen Deprivation TherapyExperimental Treatment2 Interventions

Stereotactic body radiotherapy to 27 Gy in 3 fractions to uninvolved regions of the prostate glad and up to 39 Gy in 3 fractions to mpMRI-defined intraprostatic lesions, with concurrent/adjuvant androgen deprivation therapy (6 months for intermediate risk, 24 months for high risk)

0 / 6Eligibility criteria met