Hypofractionated vs Standard Radiotherapy for Prostate Cancer

(HOPE Trial)

Recruiting at 2 trial locations

Overseen By Lucas Mendez, MD

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's

Disqualifiers: Metastasis, Inflammatory bowel, Connective tissue, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 7

Duration: 5-25 fractions

58 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this research study is to determine if 5 (five) fractions of external radiotherapy with higher radiation doses per fraction to the pelvis leads to similar results to the standard of care external radiotherapy treatment that is comprised of 25 fractions of external radiotherapy with lower radiation doses per fraction to the pelvis. This study aims to investigate the impact in quality of life associated with hypofractionated Whole Pelvis Radiotherapy (WPRT) in comparison to conventionally-fractionated WPRT in patients with unfavorable-intermediate and high-risk prostate cancers. This information is valuable as hypofractionated WPRT is a more attractive and convenient treatment approach, and may become the new standard of care if proven to be well-tolerated and effective. Therefore, this study aims to provide a more rational justification for use of hypofractionated WPRT in future larger randomized trials by comparing this strategy with the current standard of care. This study will also provide an initial understanding of the toxicity profile and cancer control associated with hypofractionated WPRT and High Dose Rate Brachytherapy (HDR-BT).

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Hypofractionated vs Standard Radiotherapy for Prostate Cancer?

Research suggests that hypofractionated radiotherapy, which involves giving higher doses of radiation over fewer sessions, may be as effective as standard radiotherapy for prostate cancer. Studies indicate that it can achieve similar survival rates and may improve outcomes for high-risk patients, although it is still being investigated for its effects on quality of life and potential side effects. ^{1 2 3 4 5}

Is hypofractionated radiotherapy safe for prostate cancer patients?

Research suggests that hypofractionated radiotherapy, which involves giving higher doses of radiation over a shorter period, generally has low levels of side effects compared to traditional methods. Studies have shown that it is well-tolerated in prostate cancer patients, with similar safety profiles to conventional treatments. ^{1 2 5 6 7}

How is hypofractionated radiotherapy different from standard treatment for prostate cancer?

Hypofractionated radiotherapy for prostate cancer uses larger doses of radiation over fewer sessions compared to standard treatment, which can make it more convenient and potentially more effective. It may also improve outcomes by delivering higher doses to the prostate while sparing surrounding healthy tissue, although it might not reduce side effects related to the urinary and digestive systems. ^{3 8 9 10 11}

Research Team

Lucas C Mendez, MD

Principal Investigator

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Eligibility Criteria

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.

Inclusion Criteria

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

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

I am fully active or can carry out light work.

Exclusion Criteria

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

I cannot or do not want to fill out questionnaires.

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either hypofractionated WPRT (5 fractions) or conventionally-fractionated WPRT (25 fractions) with HDR brachytherapy boost

5-25 fractions

5-25 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including quality of life and toxicity assessments

2 years

Multiple visits (in-person and virtual) over 2 years

Long-term Follow-up

Participants are monitored for long-term outcomes such as overall survival and biochemical failure-free survival

Up to 7 years

Treatment Details

Interventions

• Conventionally-fractionated WPRT
• Hypofractionated WPRT

Trial Overview 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.

Participant Groups

Group I: Hypofractionated WPRT Experimental Treatment 1 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 WPRT Active Control 1 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.

Who Is Running the Clinical Trial?

London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

686

Recruited

427,000+

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

678

Recruited

421,000+

London Health Sciences Centre OR Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

668

Recruited

424,000+

Lawson Health Research Institute

Lead Sponsor

Trials

684

Recruited

432,000+

AbbVie

Industry Sponsor

Trials

1,079

Recruited

535,000+

Founded

2013

Headquarters

North Chicago, USA

Known For

Immunology treatments

Top Products

Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

Canadian Association of Radiation Oncology

Industry Sponsor

Trials

8

Recruited

500+

Findings from Research

This phase II study involves 58 patients with high-risk prostate cancer, comparing the effects of hypofractionated whole pelvis radiotherapy (WPRT) to conventionally fractionated WPRT, focusing on late bowel toxicity as the primary endpoint.

If hypofractionated WPRT proves to be well-tolerated and effective, it could become the new standard of care for treating high-risk prostate cancer, offering a more convenient treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is hypofractionated whole pelvis radiotherapy (WPRT) as well tolerated as conventionally fractionated WPRT in prostate cancer patients? The HOPE trial. Mendez, LC., Arifin, AJ., Bauman, GS., et al.[2021]

Prostate hypofractionation, which involves delivering higher doses of radiation in fewer sessions, shows low morbidity and may improve outcomes for high-risk prostate cancer patients, especially when using advanced techniques like high-dose-rate brachytherapy and image-guided intensity modulated radiation therapy.

Combining whole-pelvic radiation therapy with hypofractionated prostate radiation is feasible but still under investigation, suggesting that targeting pelvic lymph nodes at high risk for cancer involvement could enhance treatment effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Whole-pelvic nodal radiation therapy in the context of hypofractionation for high-risk prostate cancer patients: a step forward. Kaidar-Person, O., Roach, M., Créhange, G.[2022]

In a study of 820 patients with localized prostate cancer, hypofractionated radiation therapy showed similar 5-year relapse-free survival rates compared to conventional radiation therapy, but it did not demonstrate noninferiority in terms of genitourinary and gastrointestinal quality of life.

While hypofractionation did not perform as well for urinary and gastrointestinal symptoms, it was found to be noninferior for other aspects of quality of life, such as symptoms related to androgen deprivation therapy and sexual function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Moderate Hypofractionation in Intermediate- and High-Risk, Localized Prostate Cancer: Health-Related Quality of Life From the Randomized, Phase 3 HYPRO Trial. Wortel, RC., Oomen-de Hoop, E., Heemsbergen, WD., et al.[2019]

In a study of 41 patients with high-risk localized prostate cancer, combining whole-pelvis irradiation with a stereotactic body radiotherapy (SBRT) boost resulted in a high 4-year biochemical failure-free survival rate of 91.9%, indicating effective cancer control.

The treatment was associated with minimal toxicity, with no severe (grade 3) gastrointestinal or genitourinary side effects reported, suggesting that this approach is safe for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The early result of whole pelvic radiotherapy and stereotactic body radiotherapy boost for high-risk localized prostate cancer. Lin, YW., Lin, LC., Lin, KL.[2020]

The Scandinavian HYPO-RT-PC trial, involving 1200 men with intermediate-to-high-risk prostate cancer, demonstrated that ultra-hypofractionated radiotherapy (42.7 Gy in seven fractions) is non-inferior to conventional fractionation (78.0 Gy in 39 fractions) in terms of failure-free survival over a median follow-up of 5 years.

While ultra-hypofractionation resulted in more acute urinary and bowel symptoms during treatment, late toxicity rates were similar to those of conventional fractionation, suggesting that ultra-hypofractionation is a safe and effective option for prostate cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultra-hypofractionated versus conventionally fractionated radiotherapy for prostate cancer: 5-year outcomes of the HYPO-RT-PC randomised, non-inferiority, phase 3 trial. Widmark, A., Gunnlaugsson, A., Beckman, L., et al.[2019]

In a study of 289 prostate cancer patients, hypofractionated proton beam therapy (PBT) showed no significant differences in acute adverse event rates or quality of life, as measured by the International Prostate Symptom Score (IPSS), compared to conventionally fractionated PBT.

The study evaluated patients treated with different doses (2.0, 2.5, and 3.0 Gy RBE per fraction) and found that factors like diabetes, age, and androgen deprivation therapy did not influence the IPSS outcomes, suggesting that hypofractionated PBT is a safe option without increased toxicity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute toxicity and patient-reported symptom score after conventional versus moderately hypofractionated proton therapy for prostate cancer. Iizumi, T., Ishikawa, H., Sekino, Y., et al.[2022]

Hypofractionated radiotherapy for prostate cancer, which delivers larger doses in fewer sessions, has shown improved biochemical control of the disease, supported by multiple clinical trials.

Advanced radiation techniques like 3D conformal radiotherapy and intensity modulated radiation therapy enable higher doses to the prostate while protecting surrounding healthy tissues, making hypofractionation a safer and more effective option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of hypofractionated radiotherapy for prostate cancer. Spyropoulou, D., Kardamakis, D.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

Is hypofractionated whole pelvis radiotherapy (WPRT) as well tolerated as conventionally fractionated WPRT in prostate cancer patients? The HOPE trial. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Whole-pelvic nodal radiation therapy in the context of hypofractionation for high-risk prostate cancer patients: a step forward. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Moderate Hypofractionation in Intermediate- and High-Risk, Localized Prostate Cancer: Health-Related Quality of Life From the Randomized, Phase 3 HYPRO Trial. [2019]

4. Switzerland pubmed.ncbi.nlm.nih.gov

The early result of whole pelvic radiotherapy and stereotactic body radiotherapy boost for high-risk localized prostate cancer. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Ultra-hypofractionated versus conventionally fractionated radiotherapy for prostate cancer: 5-year outcomes of the HYPO-RT-PC randomised, non-inferiority, phase 3 trial. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Acute toxicity and patient-reported symptom score after conventional versus moderately hypofractionated proton therapy for prostate cancer. [2022]

7. India pubmed.ncbi.nlm.nih.gov

Hypofractionated radiotherapy for localized prostate cancer using three-dimensional conformal radiotherapy technique: 3 years toxicity analysis. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

A prospective phase III randomized trial of hypofractionation versus conventional fractionation in patients with high-risk prostate cancer. [2022]

9. Japan pubmed.ncbi.nlm.nih.gov

The 5-year outcomes of moderately hypofractionated radiotherapy (66 Gy in 22 fractions, 3 fractions per week) for localized prostate cancer: a retrospective study. [2018]

10. England pubmed.ncbi.nlm.nih.gov

Hypofractionated radiotherapy versus conventional radiotherapy in patients with intermediate- to high-risk localized prostate cancer: a meta-analysis of randomized controlled trials. [2022]

11. Egypt pubmed.ncbi.nlm.nih.gov

Review of hypofractionated radiotherapy for prostate cancer. [2021]