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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 5 years

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 9Eligibility criteria met