- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04197141
Hypofractionated Whole-Pelvis Radiotherapy (WPRT) vs Conventionally-Fractionated WPRT in Prostate Cancer (HOPE)
Is Hypofractionated Whole-Pelvis Radiotherapy (WPRT) as Well Tolerated as Conventionally-Fractionated WPRT in Prostate Cancer Patients? (HOPE-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).
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Alberta
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Calgary, Alberta, Canada, T2N 4N2
- Tom Baker Cancer Centre
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British Columbia
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Kelowna, British Columbia, Canada, V1Y 5L3
- BC Cancer
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Ontario
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London, Ontario, Canada, N6A 5W9
- London Regional Cancer Program of the Lawson Health Research Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 18 or older
- Study Informed Consent provided
- Pathologically proven diagnosis of prostatic adenocarcinoma
- Unfavorable intermediate risk [with greater than 15% chance of node involvement based on Memorial Sloan Kettering Cancer Center (MSKCC) nomogram https://www.mskcc.org/nomograms/prostate] 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]
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
- No prior history of pelvic irradiation, brachytherapy, cryosurgery, High-Intensity Focused Ultrasound (HIFU), Transurethral Resection of the Prostate (TURP) or radical prostatectomy
Exclusion Criteria:
- Presence of nodal or distant metastasis, as confirmed by Magnetic Resonance Imaging (MRI) or Computerized Tomography (CT) of the chest/abdomen/pelvis and bone scan within 45 days of randomization
- Plan for adjuvant docetaxel post-radiotherapy
- Serious medical comorbidities or other contraindications to HDR-BT
- Presence of inflammatory bowel disease
- Presence of connective tissue disease
- Medically unfit for general anesthesia
- Unable or unwilling to complete questionnaires
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Conventionally-fractionated WPRT
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.
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Total dose: 45 Gy in 25 fractions WPRT
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Experimental: Hypofractionated WPRT
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.
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Total dose: 25 Gy in 5 fractions WPRT
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of Life (QOL) - late bowel function as measured by the EPIC questionnaire
Time Frame: I year post treatment (approximately 3 years and 2 months)
|
Late bowel function as reported by the patient using the standardized questionnaire Expanded Prostate Cancer Index Composite (EPIC) sub-domain approximately 1 year after the end of treatment.
The EPIC questionnaire contains 32 questions measuring patient function.
Each question has a response option ranging from 0 or 1 (best) to 3, 4, or 5 (worst).
The responses then correlate to a scoring scale of 0 to 100, where 0 is the best and 100 is the worst.
The values vary from 0 to 100 for each question.
The scores can then be added to come up with an overall quality of life score.
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I year post treatment (approximately 3 years and 2 months)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of Life - acute urinary and sexual QOL as measured by the EPIC questionnaire
Time Frame: 6 weeks post treatment (approximately 2 years and 3 months)
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Acute urinary and sexual QOL as reported by the patient using the standardized questionnaire Expanded Prostate Cancer Index Composite (EPIC) urinary and sexual domains.
The EPIC questionnaire contains 32 questions measuring patient function.
Each question has a response option ranging from 0 or 1 (best) to 3, 4, or 5 (worst).
The responses then correlate to a scoring scale of 0 to 100, where 0 is the best and 100 is the worst.
The values vary from 0 to 100 for each question.
The scores can then be added to come up with an overall quality of life score.
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6 weeks post treatment (approximately 2 years and 3 months)
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Quality of Life - acute bowel toxicity as measured by the EPIC questionnaire
Time Frame: 6 weeks post treatment (approximately 2 years and 3 months)
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Acute bowel function as reported by the patient using the standardized questionnaire Expanded Prostate Cancer Index Composite (EPIC) approximately 6 weeks after the end of treatment.
The EPIC questionnaire contains 32 questions measuring patient function.
Each question has a response option ranging from 0 or 1 (best) to 3, 4, or 5 (worst).
The responses then correlate to a scoring scale of 0 to 100, where 0 is the best and 100 is the worst.
The values vary from 0 to 100 for each question.
The scores can then be added to come up with an overall quality of life score.
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6 weeks post treatment (approximately 2 years and 3 months)
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Quality of Life - late bowel bother as measured by the EPIC questionnaire
Time Frame: I year post treatment (approximately 3 years and 2 months)
|
Late bowel bother as reported by the patient using the standardized questionnaire Expanded Prostate Cancer Index Composite (EPIC) sub-domain approximately 1 year after the end of treatment.
The EPIC questionnaire contains 32 questions measuring patient function.
Each question has a response option ranging from 0 or 1 (best) to 3, 4, or 5 (worst).
The responses then correlate to a scoring scale of 0 to 100, where 0 is the best and 100 is the worst.
The values vary from 0 to 100 for each question.
The scores can then be added to come up with an overall quality of life score.
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I year post treatment (approximately 3 years and 2 months)
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Quality of Life - late urinary and sexual QOL as measured by the EPIC questionnaire
Time Frame: I year post treatment (approximately 3 years and 2 months)
|
Late urinary and sexual QOL as reported by the patient using the standardized questionnaire Expanded Prostate Cancer Index Composite (EPIC).
The EPIC questionnaire contains 32 questions measuring patient function.
Each question has a response option ranging from 0 or 1 (best) to 3, 4, or 5 (worst).
The responses then correlate to a scoring scale of 0 to 100, where 0 is the best and 100 is the worst.
The values vary from 0 to 100 for each question.
The scores can then be added to come up with an overall quality of life score.
|
I year post treatment (approximately 3 years and 2 months)
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International Prostate Symptom Score (IPSS)
Time Frame: 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)
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International Prostate Symptom Score (IPSS) as reported by the patient at 6 weeks, 1 year, and 2 years post treatment.
The IPSS is a tool used for monitoring symptoms of prostate enlargement (benign prostatic hyperplasia).
There are 7 questions related to urinary function.
Responses are on a scale from 0 (best) to 5 (worst).
Responses are added to come up with a total score, measuring if the patient is mildly symptomatic, moderately symptomatic, or severely symptomatic.
There is 1 quality of life question related to urinary symptoms.
Responses are on a scale from 0 (best) to 6 (worst).
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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)
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Toxicity - urinary, bowel, and sexual as measured by CTCAE version 4.0
Time Frame: 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)
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Urinary, bowel, and sexual toxicity will be measured by the Common Terminology Criteria for Adverse Events (CTCAE) version 4, at 6 weeks, 1 year, and 2 years post treatment.
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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)
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Prostatic Specific Antigen (PSA) curve
Time Frame: 4 years post treatment (approximately 6 years and 2 months)
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PSA curve at 4 years post-treatment.
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4 years post treatment (approximately 6 years and 2 months)
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Prostatic Specific Antigen (PSA) Nadir
Time Frame: 4 years post treatment (approximately 6 years and 2 months)
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PSA nadir at 4 years post-treatment.
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4 years post treatment (approximately 6 years and 2 months)
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Cost Effectiveness of Hypofractionated WPRT
Time Frame: End of study (approximately 7 years and 2 months)
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Cost effectiveness analysis of the hypofractionated arm in comparison to the conventionally fractionated treatment arm.
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End of study (approximately 7 years and 2 months)
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Overall Survival
Time Frame: End of study (approximately 7 years and 2 months)
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The time from randomization to death from any cause.
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End of study (approximately 7 years and 2 months)
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Biochemical Failure-Free Survival
Time Frame: End of study (approximately 7 years and 2 months)
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The time from randomization to biochemical failure (based on the Phoenix definition) or death from any cause, whichever occurs first.
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End of study (approximately 7 years and 2 months)
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Freedom from Local Failure
Time Frame: End of study (approximately 7 years and 2 months)
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The time from randomization to first local failure.
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End of study (approximately 7 years and 2 months)
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Freedom from Regional Failure
Time Frame: End of study (approximately 7 years and 2 months)
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The time from randomization to first regional failure.
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End of study (approximately 7 years and 2 months)
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Androgen Deprivation Therapy Free Survival
Time Frame: End of study (approximately 7 years and 2 months)
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The time from randomization to start of salvage ADT, death or last follow-up.
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End of study (approximately 7 years and 2 months)
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Metastasis Free Survival
Time Frame: End of study (approximately 7 years and 2 months)
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The time from randomization to development of metastasis, death or last follow-up.
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End of study (approximately 7 years and 2 months)
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Prostate Cancer Free Survival
Time Frame: End of study (approximately 7 years and 2 months)
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The time from randomization to death attributed to prostate cancer.
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End of study (approximately 7 years and 2 months)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Lucas C Mendez, MD, Lawson Health Research Institute
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HOPE Trial
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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