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Radiation Therapy

Radiation Therapy for Prostate Cancer (ASCENDE-SBRT Trial)

Phase 3
Recruiting
Research Sponsored by Canadian Cancer Trials Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants must be ≥ 18 years of age
Participants with unfavourable risk prostate cancer according to NCCN classification guidelines
Must not have
Prostate volume > 60cc before start of ADT
Contraindication to radical prostate radiotherapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8.6 years
Awards & highlights

Summary

This trial is comparing whether giving higher doses of radiation over a shorter period using special equipment (SBRT) is as effective as the usual external radiation therapy combined with a brachytherapy boost for prostate

Who is the study for?
Men with prostate cancer diagnosed in the last 9 months can join this trial. They must have intermediate or high-risk factors like a Gleason score of 7-10, PSA levels of 10-20 ng/ml or higher, and certain stages of tumor growth (cT2b to cT4). Men who don't meet these specific cancer characteristics cannot participate.
What is being tested?
The study is comparing two types of radiation therapy for prostate cancer. One group will receive SBRT, which is a high-dose radiation treatment given over fewer sessions. The other group gets usual external radiation plus brachytherapy, where radioactive material is placed inside the prostate.
What are the potential side effects?
Radiation treatments may cause side effects such as fatigue, skin reactions in treated areas, frequent urination with discomfort or burning sensation, bowel urgency or discomfort, and potential sexual dysfunction.

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 prostate cancer is classified as high-risk.
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I have not received any treatments for prostate cancer.
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My urinary symptoms are mild to moderate.
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I am HIV positive, on treatment, and my viral load is undetectable.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My prostate is larger than 60cc before starting hormone therapy.
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I cannot undergo intensive prostate cancer radiation due to health reasons.
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I am on blood thinners or have a bleeding disorder.
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I have had surgery or treatment on my prostate before.
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My body's structure makes precise brachytherapy impossible.
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I have had radiation therapy to my pelvic area before.
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My cancer is not responding to hormone therapy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8.6 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8.6 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Economic Outcomes using EQ-5D-5L
Economic Outcomes using FACIT-COST

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: SBRTExperimental Treatment1 Intervention
Group II: EBRT + Brachy BoostActive Control1 Intervention

Find a Location

Who is running the clinical trial?

Canadian Cancer Trials GroupLead Sponsor
127 Previous Clinical Trials
67,564 Total Patients Enrolled
10 Trials studying Prostate Cancer
6,425 Patients Enrolled for Prostate Cancer
NRG OncologyOTHER
236 Previous Clinical Trials
101,565 Total Patients Enrolled
19 Trials studying Prostate Cancer
11,591 Patients Enrolled for Prostate Cancer
Andrew LoblawStudy ChairOdette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, ON, Canada
~473 spots leftby Oct 2032
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