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Radiation Therapy

Radiotherapy Schedules for High Risk Prostate Cancer

N/A
Waitlist Available
Research Sponsored by Dr. Patrick Cheung
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
T1-2 N0 M0, Gleason Score <= 7, PSA 20 - 100
T1-2 N0 M0, Gleason Score 8 - 10, PSA <= 100
Must not have
Patients with unilateral or bilateral hip replacement
Patients with previous radiotherapy to the pelvis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 5 years
Awards & highlights

Summary

This trial is testing whether a different radiotherapy schedule can reduce side effects in patients with high risk prostate cancer.

Who is the study for?
This trial is for men with high-risk, localized prostate cancer. Eligible participants have a Gleason Score of 7-10 and PSA levels up to 100, without spread to lymph nodes or distant organs. Men with hip replacements, certain genetic disorders like ataxia telangiectasia, active inflammatory diseases, or previous pelvic radiotherapy cannot join.
What is being tested?
The study compares two radiation therapy schedules: conventional fractionation (standard doses over a longer period) versus hypofractionated boost (higher doses in a shorter period). The main goal is to see which method causes fewer short-term side effects.
What are the potential side effects?
Potential side effects include skin reactions in the treated area, fatigue, urinary issues such as increased frequency or discomfort during urination, bowel changes like diarrhea or rectal bleeding, and erectile dysfunction.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My prostate cancer is early stage, with a low Gleason score and a PSA level between 20-100.
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My prostate cancer is early stage, aggressive, and my PSA is 100 or less.
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My prostate cancer is at stage T3 N0 M0, with any Gleason score and a PSA of 100 or less.
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My prostate cancer diagnosis was confirmed through a tissue examination.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had a hip replacement surgery on one or both sides.
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I have had radiation therapy to my pelvic area before.
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I have been diagnosed with ataxia telangiectasia.
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My cancer has spread to lymph nodes or other parts of my body.
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I have active inflammatory bowel disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 5 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
Acute Toxicity
Secondary study objectives
Biochemical Control (Phoenix Definition)
Late Toxicity
Overall Survival

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: HypofractionationExperimental Treatment1 Intervention
Using a one phase IMRT plan, the pelvic lymph nodes will be treated to a dose of 48 Gy in 25 fractions, while the prostate will be treated to a dose of 68 Gy in 25 fractions concomitantly (simulataneous integrated boost).
Group II: Standard FractionationActive Control1 Intervention
Using 2 sequential IMRT plans, the pelvic lymph nodes and prostate will initially be treated to 46 Gy in 23 fractions, followed by a subsequent boost to the prostate to a total dose of 78 Gy.

Find a Location

Who is running the clinical trial?

Dr. Patrick CheungLead Sponsor
1 Previous Clinical Trials
Patrick Cheung, MDStudy ChairToronto Sunnybrook Regional Cancer Centre
2 Previous Clinical Trials
262 Total Patients Enrolled
2 Trials studying Prostate Cancer
262 Patients Enrolled for Prostate Cancer

Media Library

Conventionally Fractionated Boost (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03526510 — N/A
Prostate Cancer Research Study Groups: Standard Fractionation, Hypofractionation
Prostate Cancer Clinical Trial 2023: Conventionally Fractionated Boost Highlights & Side Effects. Trial Name: NCT03526510 — N/A
Conventionally Fractionated Boost (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03526510 — N/A
~12 spots leftby Sep 2025
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