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

Primary Purpose

Prostate Cancer

Status
Active
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Conventionally-fractionated WPRT
Hypofractionated WPRT
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Unfavorable intermediate risk, High risk

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Tom Baker Cancer Centre
  • BC Cancer
  • London Regional Cancer Program of the Lawson Health Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Conventionally-fractionated WPRT

Hypofractionated WPRT

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Quality of Life - acute urinary and sexual QOL as measured by the EPIC questionnaire
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.
Quality of Life - acute bowel toxicity as measured by the EPIC questionnaire
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.
Quality of Life - late bowel bother as measured by the EPIC questionnaire
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.
Quality of Life - late urinary and sexual QOL as measured by the EPIC questionnaire
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.
International Prostate Symptom Score (IPSS)
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).
Toxicity - urinary, bowel, and sexual as measured by CTCAE version 4.0
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.
Prostatic Specific Antigen (PSA) curve
PSA curve at 4 years post-treatment.
Prostatic Specific Antigen (PSA) Nadir
PSA nadir at 4 years post-treatment.
Cost Effectiveness of Hypofractionated WPRT
Cost effectiveness analysis of the hypofractionated arm in comparison to the conventionally fractionated treatment arm.
Overall Survival
The time from randomization to death from any cause.
Biochemical Failure-Free Survival
The time from randomization to biochemical failure (based on the Phoenix definition) or death from any cause, whichever occurs first.
Freedom from Local Failure
The time from randomization to first local failure.
Freedom from Regional Failure
The time from randomization to first regional failure.
Androgen Deprivation Therapy Free Survival
The time from randomization to start of salvage ADT, death or last follow-up.
Metastasis Free Survival
The time from randomization to development of metastasis, death or last follow-up.
Prostate Cancer Free Survival
The time from randomization to death attributed to prostate cancer.

Full Information

First Posted
December 6, 2019
Last Updated
August 16, 2023
Sponsor
Lawson Health Research Institute
Collaborators
Canadian Association of Radiation Oncology, AbbVie
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1. Study Identification

Unique Protocol Identification Number
NCT04197141
Brief Title
Hypofractionated Whole-Pelvis Radiotherapy (WPRT) vs Conventionally-Fractionated WPRT in Prostate Cancer
Acronym
HOPE
Official Title
Is Hypofractionated Whole-Pelvis Radiotherapy (WPRT) as Well Tolerated as Conventionally-Fractionated WPRT in Prostate Cancer Patients? (HOPE-Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 7, 2020 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lawson Health Research Institute
Collaborators
Canadian Association of Radiation Oncology, AbbVie

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Unfavorable intermediate risk, High risk

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
58 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conventionally-fractionated WPRT
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Hypofractionated WPRT
Arm Type
Experimental
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
Conventionally-fractionated WPRT
Intervention Description
Total dose: 45 Gy in 25 fractions WPRT
Intervention Type
Radiation
Intervention Name(s)
Hypofractionated WPRT
Intervention Description
Total dose: 25 Gy in 5 fractions WPRT
Primary Outcome Measure Information:
Title
Quality of Life (QOL) - late bowel function as measured by the EPIC questionnaire
Description
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.
Time Frame
I year post treatment (approximately 3 years and 2 months)
Secondary Outcome Measure Information:
Title
Quality of Life - acute urinary and sexual QOL as measured by the EPIC questionnaire
Description
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.
Time Frame
6 weeks post treatment (approximately 2 years and 3 months)
Title
Quality of Life - acute bowel toxicity as measured by the EPIC questionnaire
Description
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.
Time Frame
6 weeks post treatment (approximately 2 years and 3 months)
Title
Quality of Life - late bowel bother as measured by the EPIC questionnaire
Description
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.
Time Frame
I year post treatment (approximately 3 years and 2 months)
Title
Quality of Life - late urinary and sexual QOL as measured by the EPIC questionnaire
Description
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.
Time Frame
I year post treatment (approximately 3 years and 2 months)
Title
International Prostate Symptom Score (IPSS)
Description
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).
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)
Title
Toxicity - urinary, bowel, and sexual as measured by CTCAE version 4.0
Description
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.
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)
Title
Prostatic Specific Antigen (PSA) curve
Description
PSA curve at 4 years post-treatment.
Time Frame
4 years post treatment (approximately 6 years and 2 months)
Title
Prostatic Specific Antigen (PSA) Nadir
Description
PSA nadir at 4 years post-treatment.
Time Frame
4 years post treatment (approximately 6 years and 2 months)
Title
Cost Effectiveness of Hypofractionated WPRT
Description
Cost effectiveness analysis of the hypofractionated arm in comparison to the conventionally fractionated treatment arm.
Time Frame
End of study (approximately 7 years and 2 months)
Title
Overall Survival
Description
The time from randomization to death from any cause.
Time Frame
End of study (approximately 7 years and 2 months)
Title
Biochemical Failure-Free Survival
Description
The time from randomization to biochemical failure (based on the Phoenix definition) or death from any cause, whichever occurs first.
Time Frame
End of study (approximately 7 years and 2 months)
Title
Freedom from Local Failure
Description
The time from randomization to first local failure.
Time Frame
End of study (approximately 7 years and 2 months)
Title
Freedom from Regional Failure
Description
The time from randomization to first regional failure.
Time Frame
End of study (approximately 7 years and 2 months)
Title
Androgen Deprivation Therapy Free Survival
Description
The time from randomization to start of salvage ADT, death or last follow-up.
Time Frame
End of study (approximately 7 years and 2 months)
Title
Metastasis Free Survival
Description
The time from randomization to development of metastasis, death or last follow-up.
Time Frame
End of study (approximately 7 years and 2 months)
Title
Prostate Cancer Free Survival
Description
The time from randomization to death attributed to prostate cancer.
Time Frame
End of study (approximately 7 years and 2 months)

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lucas C Mendez, MD
Organizational Affiliation
Lawson Health Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tom Baker Cancer Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
BC Cancer
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y 5L3
Country
Canada
Facility Name
London Regional Cancer Program of the Lawson Health Research Institute
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33036579
Citation
Mendez LC, Arifin AJ, Bauman GS, Velker VM, Ahmad B, Lock M, Venkatesan VM, Sexton TL, Rodrigues GB, Chen J, Schaly B, Warner A, D'Souza DP. Is hypofractionated whole pelvis radiotherapy (WPRT) as well tolerated as conventionally fractionated WPRT in prostate cancer patients? The HOPE trial. BMC Cancer. 2020 Oct 9;20(1):978. doi: 10.1186/s12885-020-07490-0.
Results Reference
derived

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

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