Prostate CancerMOB-RTNCT05313815
Moderate Hypofractionated Boost to the Prostate With Pelvic RT in High Risk Prostate Cancer
A study testing Moderate hypofractionated boost to the prostate with pelvic RT (external beam radiotherapy) in people with Prostate Cancer, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
This is a single-arm phase II prospective trials that is recruiting 100 participants. The study population that is being investigated are patients with localized high-risk or node-positive prostate cancer. 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?
- Moderate hypofractionated boost to the prostate with pelvic RT (external beam radiotherapy)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 18 Jul 2022to Apr 2030
- Phase
- Interventional
- 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 years.
- Able to provide informed consent.
- Histologic diagnosis of prostate adenocarcinoma.
- ECOG performance status 0-1.
- High-risk localized disease by NCCN criteria (>cT3, Grade group >4, or PSA >20 ng/mL) or clinical N1 disease.
- Clinical M0 by conventional imaging (computed tomography (CT) and bone scan (BS)) and/or molecular imaging (prostate specific membrane antigen (PSMA)- positron emission tomography (PET))
Who cannot join
- Prior pelvic radiotherapy.
- Contraindications to radiotherapy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Princess Margaret Cancer Center
Toronto, Ontario, M5G 2M9
Rachel Glicksman, MD, 416-946-4483, rachel.glicksman@rmp.uhn.ca
About this study
This is a single-arm phase II prospective trials that is recruiting 100 participants. The study population that is being investigated are patients with localized high-risk or node-positive prostate cancer. Participants will receive external beam radiotherapy as a moderately hypofractionated boost to the prostate with pelvic radiation therapy. Androgen deprivation therapy will be prescribed at the discretion of the treating physician as per standard of care.
- Conditions
- Prostate Cancer
- Being tested
- Moderate hypofractionated boost to the prostate with pelvic RT (external beam radiotherapy)
- Keywords
- prostate cancer, high risk prostate cancer, high-risk prostate cancer, node positive prostate cancer, nod-positive prostate cancer, hypofractionation
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderate hypofractionated boost to the prostate with pelvic RT (external beam radiotherapy)Radiation
External beam radiotherapy- 60 Gy in 20 fractions to the prostate, 48 Gy in 20 fractions to the pelvis, 68 Gy in 20 fraction optional boost to prostatic dominant intraprostatic lesion, 55 Gy in 20 fraction optional boost to involved pelvic lymph nodes
| Study group | Role | What they receive |
|---|---|---|
| Moderate Hypofracitonated Boost to the Prostate with Pelvic Radiation Therapy | Experimental | External beam radiotherapy- 60 Gy in 20 fractions to the prostate, 48 Gy in 20 fractions to the pelvis, 68 Gy in 20 fraction optional boost to prostatic dominant intraprostatic lesion, 55 Gy in 20 fraction optional boost to involved pelvic lymph nodes Receives: Radiation: Moderate hypofractionated boost to the prostate with pelvic RT (external beam radiotherapy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute Grade >2 Gastrointestinal Toxicity
Acute (less than or equal to 90 days) toxicity will be evaluated by using prospective follow-up and grading according to the latest version of the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Measured: Baseline to 5-year follow-up
Secondary outcomes (8)
Patient-reported quality-of-life assessed by EPIC-26
Patient-Reported Quality of Life will be assessed at baseline and at each follow-up visit (3-weeks post intervention then every 6 months until 5 years, or more frequently if clinically necessary) using the following assessment questionnaires: 26-Item Expanded Prostate Cancer Index Composite (EPIC-26)
Measured: Baseline to 5-year Follow-up
Measure the severity of lower urinary tract symptoms during the study
Patient-Reported symptoms will be assessed at baseline and at each follow-up visit (3-weeks post intervention then every 6 months until 5 years, or more frequently if clinically necessary) using the following assessment questionnaires: International Prostate Symptom Score (IPSS)
Measured: Baseline to 5-year Follow-up
Graded criteria based on CTCAE version 5.0 for acute genitourinary toxicity and late genitourinary and gastrointestinal toxicity
Acute (less than or equal to 90 days) and long-term (greater than 90 days) toxicity will be evaluated by using prospective follow-up and grading according to the latest version of the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Measured: Baseline to 5-year Follow-up
Measure of oncologic outcomes
Time to development of castrate-resistant prostate cancer (biochemmical or ardiographic progression while having castrate levels of testosterone)
Measured: Baseline to 5-year Follow-up
Measure of oncologic outcomes
Biochemical control rate will be assessed at baseline and at each follow-up visit (3 weeks after treatment then every 6 months until 5 years or more frequently if clinically necessary) by the blood level of prostate-specific antigen (PSA) levels
Measured: Baseline to 5-year Follow-up
Measure of onocologic outcomes
Radiographic control rate will be assess at baseline and weekly during the radiotherapy intervention using cone beam CT or bone scan.
Measured: Baseline to 5-year Follow-up
Prostate cancer specific survival based on death from prostate cancer
Safety will be evaluated by recording prostate cancer mortality at follow-up visits (3-weeks post intervention then every 6 months until 5 years, or more frequently if clinically necessary)
Measured: Baseline to 5-year Follow-up
Overall survival
Safety will be evaluated by recording overall mortality at follow-up visits (3-weeks post intervention then every 6 months until 5 years, or more frequently if clinically necessary).
Measured: Baseline to 5-year Follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2022
- Study start18 Jul 2022
- Primary completionApr 2030 (estimated)
- Study completionApr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05313815
- Sponsor's protocol ID
- 22-5218
- Acronym
- MOB-RT
- Status last verified
- Jun 2026
- First submitted
- 15 Mar 2022
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Moderate Hypofractionated Boost to the Prostate With Pelvic RT in High Risk Prostate Cancer
- ClinicalTrials.gov ID
- NCT05313815
- Acronym / sponsor ID
- MOB-RT / 22-5218
- Conditions
- Prostate Cancer
- Keywords
- prostate cancer, high risk prostate cancer, high-risk prostate cancer, node positive prostate cancer, nod-positive prostate cancer, hypofractionation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 18 Jul 2022 (actual)
- Primary completion
- Apr 2030 (estimated)
- Study completion
- Apr 2030 (estimated)
- First posted
- 6 Apr 2022 (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.
This is a single-arm phase II prospective trials that is recruiting 100 participants. The study population that is being investigated are patients with localized high-risk or node-positive prostate cancer. Participants will receive external beam radiotherapy as a moderately hypofractionated boost to the prostate with pelvic radiation therapy. Androgen deprivation therapy will be prescribed at the discretion of the treating physician as per standard of care.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Moderate Hypofracitonated Boost to the Prostate with Pelvic Radiation Therapy | Experimental | Radiation: Moderate hypofractionated boost to the prostate with pelvic RT (external beam radiotherapy)External beam radiotherapy- 60 Gy in 20 fractions to the prostate, 48 Gy in 20 fractions to the pelvis, 68 Gy in 20 fraction optional boost to prostatic dominant intraprostatic lesion, 55 Gy in 20 fraction optional boost to involved pelvic lymph nodes |
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 years.
- Able to provide informed consent.
- Histologic diagnosis of prostate adenocarcinoma.
- ECOG performance status 0-1.
- High-risk localized disease by NCCN criteria (>cT3, Grade group >4, or PSA >20 ng/mL) or clinical N1 disease.
Key exclusion criteria (2 listed)
- Prior pelvic radiotherapy.
- Contraindications to radiotherapy
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 |
|---|---|---|
| Moderate hypofractionated boost to the prostate with pelvic RT (external beam radiotherapy)External beam radiotherapy- 60 Gy in 20 fractions to the prostate, 48 Gy in 20 fractions to the pelvis, 68 Gy in 20 fraction optional boost to prostatic dominant intraprostatic lesion, 55 Gy in 20 fraction optional boost to involved pelvic lymph nodes | Radiation | Moderate Hypofracitonated Boost to the Prostate with Pelvic Radiation Therapy |
Primary outcome
Acute Grade >2 Gastrointestinal Toxicity
Time frame: Baseline to 5-year follow-up
Acute (less than or equal to 90 days) toxicity will be evaluated by using prospective follow-up and grading according to the latest version of the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
8 secondary outcomes
Patient-reported quality-of-life assessed by EPIC-26
Time frame: Baseline to 5-year Follow-up
Measure the severity of lower urinary tract symptoms during the study
Time frame: Baseline to 5-year Follow-up
Graded criteria based on CTCAE version 5.0 for acute genitourinary toxicity and late genitourinary and gastrointestinal toxicity
Time frame: Baseline to 5-year Follow-up
Measure of oncologic outcomes
Time frame: Baseline to 5-year Follow-up
Measure of oncologic outcomes
Time frame: Baseline to 5-year Follow-up
Measure of onocologic outcomes
Time frame: Baseline to 5-year Follow-up
Prostate cancer specific survival based on death from prostate cancer
Time frame: Baseline to 5-year Follow-up
Overall survival
Time frame: Baseline to 5-year Follow-up
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 5 Jun 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moderate hypofractionated boost to the prostate with pelvic RT (external beam radiotherapy) in people with Prostate Cancer, run by University Health Network, Toronto at 1 site 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 2 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: looking for participants now, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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?
Contact Rachel Glicksman, MD (416-946-4486, rachel.glicksman@rmp.uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute Grade >2 Gastrointestinal Toxicity (time frame: Baseline to 5-year follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jun 2026.