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Radiation Therapy

Prostate SBRT with Focal Boost and Androgen Deprivation Therapy 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

DEFINE Trial 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.Check my eligibility

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.See study design

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.

DEFINE Trial 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.

DEFINE Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Genitourinary and gastrointestinal toxicity

Secondary outcome measures

Bowel and urinary quality of life

Disease-free survival

DEFINE 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

Find a Location

Who is running the clinical trial?

Ottawa Hospital Research InstituteLead Sponsor

561 Previous Clinical Trials

2,785,440 Total Patients Enrolled

3 Trials studying Prostate Cancer

375 Patients Enrolled for Prostate Cancer

Knight Therapeutics (USA) IncIndustry Sponsor

5 Previous Clinical Trials

103 Total Patients Enrolled

Scott C Morgan, MD, MScPrincipal InvestigatorThe Ottawa Hospital Cancer Centre

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current number of subjects enrolled in this medical study?

"Indeed, the data available on clinicaltrials.gov confirms that this ongoing clinical trial is actively seeking eligible candidates. The initial posting of the study took place on November 23, 2023, and it was last updated on January 2, 2024. With a single site involved in this research, they are aiming to enroll a total of 54 participants."

Answered by AI

Are there still available openings for new participants in this research study?

"Indeed, the details on clinicaltrials.gov indicate that this trial is presently in search of eligible participants. The initial posting date for this clinical trial was November 23rd, 2023 and it was last modified on January 2nd, 2024. A total of 54 patients are being sought from a single study site."

Answered by AI

What is the level of safety associated with Prostate Stereotactic Body Radiation Therapy (SBRT) in combination with Focal Boost and Androgen Deprivation Therapy for patients?

"Given that this trial is in Phase 2, indicating the absence of efficacy data but some supporting safety information, our team at Power rates the safety level of Prostate SBRT with Focal Boost and Androgen Deprivation Therapy as a 2 on a scale from 1 to 3."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Dose Escalation For INtraprostatic LEsions

2023. "Dose Escalation For INtraprostatic LEsions". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05851547.

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