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Radiation Therapy

Hypofractionated vs Standard Radiotherapy for Prostate Cancer (HOPE Trial)

Phase 2

Waitlist Available

Led By Lucas C Mendez, MD

Research Sponsored by Lawson Health Research Institute

Eligibility Criteria Checklist

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

Must have

No prior history of pelvic irradiation, brachytherapy, cryosurgery, High-Intensity Focused Ultrasound (HIFU), Transurethral Resection of the Prostate (TURP) or radical prostatectomy

Unfavorable intermediate risk [with greater than 15% chance of node involvement based on Memorial Sloan Kettering Cancer Center (MSKCC) nomogram or high or very-high-risk prostate cancer based on National Comprehensive Cancer Network (NCCN) classification [Prostatic Specific Antigen (PSA) > 20 ng/mL or clinical cT3a or cT3b or Gleason 8-10]

Must not have

Serious medical comorbidities or other contraindications to HDR-BT

Unable or unwilling to complete questionnaires

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 weeks post treatment (approximately 2 years and 3 months), 1 year post treatment (approximately 3 years and 2 months) and 2 years post treatment (approximately 4 years and 2 months)

Awards & highlights

No Placebo-Only Group

Summary

This trial is investigating whether a shorter, more intense course of radiation therapy is as effective as the standard 25-week course for treating prostate cancer.

Who is the study for?

This trial is for adults over 18 with a specific type of prostate cancer that's at an intermediate to very-high risk. They must have no prior major treatments on the pelvis, be in good physical condition (able to perform daily activities without assistance), and not have inflammatory or connective tissue diseases, metastasis, or serious medical conditions that would interfere with treatment.

What is being tested?

The study compares two ways of delivering radiation therapy: one uses fewer high-dose treatments (hypofractionated WPRT) while the other uses more frequent low-dose treatments (conventionally-fractionated WPRT). The goal is to see if the shorter treatment works as well as the standard one and how they both affect quality of life.

What are the potential side effects?

Potential side effects from radiotherapy may include skin irritation, fatigue, bowel and urinary issues. Since hypofractionated therapy involves higher doses per session, there might be a different pattern or intensity of side effects compared to conventional fractionation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have never had treatments like radiation or surgery on my pelvis.

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My prostate cancer is high risk with a PSA over 20 ng/mL or is in stage T3a or T3b.

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I am fully active or can carry out light work.

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I have been diagnosed with prostate cancer.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have serious health issues that prevent me from having HDR-BT.

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I cannot or do not want to fill out questionnaires.

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I cannot undergo surgery with general anesthesia due to health reasons.

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I have inflammatory bowel disease.

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I have a connective tissue disease.

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I am scheduled for additional treatment with docetaxel after radiotherapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks post treatment (approximately 2 years and 3 months), 1 year post treatment (approximately 3 years and 2 months) and 2 years post treatment (approximately 4 years and 2 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 weeks post treatment (approximately 2 years and 3 months), 1 year post treatment (approximately 3 years and 2 months) and 2 years post treatment (approximately 4 years and 2 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks post treatment (approximately 2 years and 3 months), 1 year post treatment (approximately 3 years and 2 months) and 2 years post treatment (approximately 4 years and 2 months) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Quality of Life (QOL) - late bowel function as measured by the EPIC questionnaire

Secondary study objectives

Androgen Deprivation Therapy Free Survival

Biochemical Failure-Free Survival

Cost Effectiveness of Hypofractionated WPRT

+13 more

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: Hypofractionated WPRTExperimental Treatment1 Intervention

15 Gy HDR brachytherapy boost will be administered followed by 25 Gy WPRT in 5 fractions. Androgen Deprivation Therapy (ADT) may also be prescribed at the discretion of the treating physician.

Group II: Conventionally-fractionated WPRTActive Control1 Intervention

15 Gy HDR brachytherapy boost will be administered followed by 45 Gy WPRT in 25 fractions. Androgen Deprivation Therapy (ADT) may also be prescribed at the discretion of the treating physician.

0 / 11Eligibility criteria met