Prostate CancerPhase 2HOPENCT04197141
Hypofractionated Whole-Pelvis Radiotherapy (WPRT) vs Conventionally-Fractionated WPRT in Prostate Cancer
A Phase 2 study testing Conventionally-fractionated WPRT and Hypofractionated WPRT in people with Prostate Cancer, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 3 sites in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Conventionally-fractionated WPRT and Hypofractionated WPRT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 3 sitesCanada
- Study dates
- 7 Feb 2020to Mar 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Tom Baker Cancer Centre
Calgary, Alberta, T2N 4N2
BC Cancer
Kelowna, British Columbia, V1Y 5L3
London Regional Cancer Program of the Lawson Health Research Institute
London, Ontario, N6A 5W9
About this study
Official title: 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).
- Conditions
- Prostate Cancer
- Being tested
- Conventionally-fractionated WPRT, Hypofractionated WPRT
- Keywords
- Unfavorable intermediate risk, High risk
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventionally-fractionated WPRTRadiation
Total dose: 45 Gy in 25 fractions WPRT
Hypofractionated WPRTRadiation
Total dose: 25 Gy in 5 fractions WPRT
| Study group | Role | What they receive |
|---|---|---|
| Conventionally-fractionated WPRT | Active comparator | 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. Receives: Radiation: Conventionally-fractionated WPRT |
| Hypofractionated WPRT | Experimental | 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. Receives: Radiation: Hypofractionated WPRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: I year post treatment (approximately 3 years and 2 months)
Secondary outcomes (16)
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.
Measured: 6 weeks post treatment (approximately 2 years and 3 months)
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.
Measured: 6 weeks post treatment (approximately 2 years and 3 months)
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.
Measured: I year post treatment (approximately 3 years and 2 months)
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.
Measured: I year post treatment (approximately 3 years and 2 months)
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).
Measured: 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)
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.
Measured: 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)
Prostatic Specific Antigen (PSA) curve
PSA curve at 4 years post-treatment.
Measured: 4 years post treatment (approximately 6 years and 2 months)
Prostatic Specific Antigen (PSA) Nadir
PSA nadir at 4 years post-treatment.
Measured: 4 years post treatment (approximately 6 years and 2 months)
Cost Effectiveness of Hypofractionated WPRT
Cost effectiveness analysis of the hypofractionated arm in comparison to the conventionally fractionated treatment arm.
Measured: End of study (approximately 7 years and 2 months)
Overall Survival
The time from randomization to death from any cause.
Measured: End of study (approximately 7 years and 2 months)
Biochemical Failure-Free Survival
The time from randomization to biochemical failure (based on the Phoenix definition) or death from any cause, whichever occurs first.
Measured: End of study (approximately 7 years and 2 months)
Freedom from Local Failure
The time from randomization to first local failure.
Measured: End of study (approximately 7 years and 2 months)
Freedom from Regional Failure
The time from randomization to first regional failure.
Measured: End of study (approximately 7 years and 2 months)
Androgen Deprivation Therapy Free Survival
The time from randomization to start of salvage ADT, death or last follow-up.
Measured: End of study (approximately 7 years and 2 months)
Metastasis Free Survival
The time from randomization to development of metastasis, death or last follow-up.
Measured: End of study (approximately 7 years and 2 months)
Prostate Cancer Free Survival
The time from randomization to death attributed to prostate cancer.
Measured: End of study (approximately 7 years and 2 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2019
- Study start7 Feb 2020
- Primary completionSep 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Association of Radiation Oncology, AbbVie
- Responsible party
- Sponsor
- Investigators
- Lucas C Mendez, MD, Principal investigator, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04197141
- Sponsor's protocol ID
- HOPE Trial
- Acronym
- HOPE
- Status last verified
- Sep 2026
- First submitted
- 6 Dec 2019
- Last updated
- 1 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33036579
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Hypofractionated Whole-Pelvis Radiotherapy (WPRT) as Well Tolerated as Conventionally-Fractionated WPRT in Prostate Cancer Patients? (HOPE-Trial)
- ClinicalTrials.gov ID
- NCT04197141
- Acronym / sponsor ID
- HOPE / HOPE Trial
- Conditions
- Prostate Cancer
- Keywords
- Unfavorable intermediate risk, High risk
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Collaborators
- Canadian Association of Radiation Oncology, AbbVie
- Study start
- 7 Feb 2020 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 12 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventionally-fractionated WPRT | Active comparator | Radiation: Conventionally-fractionated WPRT15 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. |
| Hypofractionated WPRT | Experimental | Radiation: Hypofractionated WPRT15 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventionally-fractionated WPRTTotal dose: 45 Gy in 25 fractions WPRT | Radiation | Conventionally-fractionated WPRT |
| Hypofractionated WPRTTotal dose: 25 Gy in 5 fractions WPRT | Radiation | Hypofractionated WPRT |
Primary outcome
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.
16 secondary outcomes
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)
Quality of Life - acute bowel toxicity as measured by the EPIC questionnaire
Time frame: 6 weeks post treatment (approximately 2 years and 3 months)
Quality of Life - late bowel bother as measured by the EPIC questionnaire
Time frame: I year post treatment (approximately 3 years and 2 months)
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)
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)
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)
Prostatic Specific Antigen (PSA) curve
Time frame: 4 years post treatment (approximately 6 years and 2 months)
Prostatic Specific Antigen (PSA) Nadir
Time frame: 4 years post treatment (approximately 6 years and 2 months)
Cost Effectiveness of Hypofractionated WPRT
Time frame: End of study (approximately 7 years and 2 months)
Overall Survival
Time frame: End of study (approximately 7 years and 2 months)
Biochemical Failure-Free Survival
Time frame: End of study (approximately 7 years and 2 months)
Freedom from Local Failure
Time frame: End of study (approximately 7 years and 2 months)
Freedom from Regional Failure
Time frame: End of study (approximately 7 years and 2 months)
Androgen Deprivation Therapy Free Survival
Time frame: End of study (approximately 7 years and 2 months)
Metastasis Free Survival
Time frame: End of study (approximately 7 years and 2 months)
Prostate Cancer Free Survival
Time frame: End of study (approximately 7 years and 2 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Derived from this study: PubMed 33036579Mendez 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lucas C Mendez, MD principal investigator
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Conventionally-fractionated WPRT and Hypofractionated WPRT in people with Prostate Cancer, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04197141, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.