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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]

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

HOPE Trial 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.Check my eligibility

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.See study design

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.

HOPE Trial 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.

HOPE Trial 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

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

Primary outcome measures

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

Secondary outcome measures

Androgen Deprivation Therapy Free Survival

Biochemical Failure-Free Survival

Cost Effectiveness of Hypofractionated WPRT

+13 more

HOPE 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 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

AbbVieIndustry Sponsor

954 Previous Clinical Trials

500,986 Total Patients Enrolled

4 Trials studying Prostate Cancer

1,520 Patients Enrolled for Prostate Cancer

Lawson Health Research InstituteLead Sponsor

656 Previous Clinical Trials

413,370 Total Patients Enrolled

15 Trials studying Prostate Cancer

587 Patients Enrolled for Prostate Cancer

Canadian Association of Radiation OncologyIndustry Sponsor

7 Previous Clinical Trials

444 Total Patients Enrolled

4 Trials studying Prostate Cancer

194 Patients Enrolled for Prostate Cancer

Media Library

$Conventionally-fractionated WPRT (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04197141 — Phase 2$

$Prostate Cancer Research Study Groups: Conventionally-fractionated WPRT, Hypofractionated WPRT$

$Prostate Cancer Clinical Trial 2023: Conventionally-fractionated WPRT Highlights & Side Effects. Trial Name: NCT04197141 — Phase 2$

$Conventionally-fractionated WPRT (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04197141 — Phase 2$

Frequently Asked Questions

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

Has the FDA greenlit Hypofractionated WPRT as a treatment?

"Even though there is no data supporting efficacy, the fact that there is some safety data leads our team to rate Hypofractionated WPRT as a 2."

Answered by AI

Are researchers looking for more participants in this clinical trial?

"No, this particular clinical trial is not looking for patients at the moment. The date when this was last updated on April 12th, 2022 shows that recruitment has ended. Although, there are 1,366 other medical trials with open recruitment presently."

Answered by AI

Recent research and studies

BMC CancerJournal

Is Hypofractionated Whole Pelvis Radiotherapy (WPRT) as Well Tolerated as Conventionally Fractionated WPRT in Prostate Cancer Patients? the HOPE Trial

Mendez, Lucas C., Andrew J. Arifin, Glenn S. Bauman, Vikram M. Velker, Belal Ahmad, Michael Lock, Varagur M. Venkatesan, et al.. 2020. “Is Hypofractionated Whole Pelvis Radiotherapy (WPRT) as Well Tolerated as Conventionally Fractionated WPRT in Prostate Cancer Patients? the HOPE Trial”. BMC Cancer. Springer Science and Business Media LLC. doi:10.1186/s12885-020-07490-0.

clinicaltrials.govStudy

Hypofractionated Whole-Pelvis Radiotherapy (WPRT) vs Conventionally-Fractionated WPRT in Prostate Cancer

2020. "Hypofractionated Whole-Pelvis Radiotherapy (WPRT) vs Conventionally-Fractionated WPRT in Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04197141.

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