Prostatic NeoplasmsPATRIOTNCT01423474
Prostate Accurately Targeted Radiotherapy Investigation of Overall Treatment Time
A study testing Image-guided radiotherapy in people with Prostatic Neoplasms, run by CancerCare Manitoba at 3 sites in Canada.
Trial summary
The purpose of this study is to compare the toxicity of two new radiation schedules for the treatment of prostate cancer. Patients will be randomized to receive 5 treatments delivered every other day over 11 days, or once per week over 29 days. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostatic Neoplasms
- What is being tested?
- Image-guided radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 3 sitesCanada
- Study dates
- Jan 2012to Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Low or intermediate risk prostate cancer patients as defined by:
- Clinical stage T1-2b, Gleason Score <=7, and PSA <=20 ng/mL
- Age >= 18 years
Who cannot join
- Androgen deprivation therapy (LHRH-agonists or antiandrogens) >6 months
- Prior pelvic radiotherapy
- Anticoagulation medication (if unsafe to discontinue for gold seed insertion)
- Diagnosis of bleeding diathesis
- Large prostate (>90cm3) on imaging
- Immunosuppressive medications
- Inflammatory bowel disease
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
BC Cancer Agency - Abbotsford Centre
Abbotsford British Columbia, British Columbia, V2S 0C2
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
CancerCare Manitoba
Winnipeg, Manitoba, R3E 0V9
About this study
Official title: Randomized Phase II Study of 2 Hypofractionated Radiotherapy Schedules for Low- and Intermediate-Risk Prostate Cancer
The purpose of this study is to compare the toxicity of two new radiation schedules for the treatment of prostate cancer. Patients will be randomized to receive 5 treatments delivered every other day over 11 days, or once per week over 29 days. Both of these schedules are shorter than the standard treatment which is usually 39 treatments over 8 weeks.
- Conditions
- Prostatic Neoplasms
- Being tested
- Image-guided radiotherapy
- Keywords
- Radiotherapy, 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.
Image-guided radiotherapyRadiation
40 Gy / 5 fractions / 11 days
Image-guided radiotherapyRadiation
40 Gy / 5 fractions / 29 days
| Study group | Role | What they receive |
|---|---|---|
| Short treatment time (11 days) | Experimental | Not described Receives: Radiation: Image-guided radiotherapy |
| Long treatment time (29 days) | Experimental | Not described Receives: Radiation: Image-guided radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bowel related quality-of-life
Measured: 3 months
Secondary outcomes (5)
Gastrointestinal toxicity
Radiation Therapy Oncology Group Acute and Late Morbidity Scoring Schema
Measured: During radiotherapy, at 3 and 6 months, then every 6 months after
Genitourinary toxicity
Radiation Therapy Oncology Group Acute and Late Morbidity Scoring Schema
Measured: During radiotherapy, at 3 and 6 months, then every 6 months after
PSA relapse rate
Measured: 3 and 5 years
Patient Overall Quality of life
Measured: During radiotherapy, at 3 and 6 months, then every 6 months after
Salvage androgen deprivation therapy rate
Measured: 3 and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2011 (estimated)
- Study startJan 2012
- Primary completionAug 2019
- Study completionAug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Prostatic NeoplasmsStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- CancerCare Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Aldrich Ong, CancerCare Manitoba
- Investigators
- Aldrich Ong, MD, Principal investigator, CancerCare ManitobaAndrew Loblaw, MD, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01423474
- Sponsor's protocol ID
- 50-2011
- Acronym
- PATRIOT
- Status last verified
- Feb 2024
- First submitted
- 23 Aug 2011
- Last updated
- 23 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Ong WL, Quon H, Ong A, Cheung P, Chu W, Chung H, Vesprini D, Chowdhury A, Panjwani D, Alayed Y, Pang G, Korol R, Davidson M, Ravi A, McCurdy B, Zhang L, Kulasingham-Poon M, Mamedov A, Deabreu A, Loblaw A. Every Other Day or Once a Week: Long-term Oncological Outcomes in the Phase 2 PATRIOT Trial of Prostate Stereotactic Ablative Body Radiotherapy. Eur Urol Oncol. 2025 Aug;8(4):909-913. doi: 10.1016/j.euo.2025.03.011. Epub 2025 Apr 26.
PubMed 40288917Quon HC, Ong A, Cheung P, Chu W, Chung HT, Vesprini D, Chowdhury A, Panjwani D, Pang G, Korol R, Davidson M, Ravi A, McCurdy B, Zhang L, Mamedov A, Deabreu A, Loblaw A. Once-weekly versus every-other-day stereotactic body radiotherapy in patients with prostate cancer (PATRIOT): A phase 2 randomized trial. Radiother Oncol. 2018 May;127(2):206-212. doi: 10.1016/j.radonc.2018.02.029. Epub 2018 Mar 15.
PubMed 29551231
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase II Study of 2 Hypofractionated Radiotherapy Schedules for Low- and Intermediate-Risk Prostate Cancer
- ClinicalTrials.gov ID
- NCT01423474
- Acronym / sponsor ID
- PATRIOT / 50-2011
- Conditions
- Prostatic Neoplasms
- Keywords
- Radiotherapy, Hypofractionation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- CancerCare ManitobaUniversity, hospital or other
- Collaborators
- Sunnybrook Health Sciences Centre, British Columbia Cancer Agency
- Study start
- Jan 2012 (actual)
- Primary completion
- Aug 2019 (actual)
- Study completion
- Aug 2019 (actual)
- First posted
- 26 Aug 2011 (estimated)
- 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 study is to compare the toxicity of two new radiation schedules for the treatment of prostate cancer. Patients will be randomized to receive 5 treatments delivered every other day over 11 days, or once per week over 29 days. Both of these schedules are shorter than the standard treatment which is usually 39 treatments over 8 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Short treatment time (11 days) | Experimental | Radiation: Image-guided radiotherapy |
| Long treatment time (29 days) | Experimental | Radiation: Image-guided radiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Low or intermediate risk prostate cancer patients as defined by:
- Age >= 18 years
Key exclusion criteria (7 listed)
- Androgen deprivation therapy (LHRH-agonists or antiandrogens) >6 months
- Prior pelvic radiotherapy
- Anticoagulation medication (if unsafe to discontinue for gold seed insertion)
- Diagnosis of bleeding diathesis
- Large prostate (>90cm3) on imaging
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 |
|---|---|---|
| Image-guided radiotherapy40 Gy / 5 fractions / 11 days | Radiation | Short treatment time (11 days) |
| Image-guided radiotherapy40 Gy / 5 fractions / 29 days | Radiation | Long treatment time (29 days) |
Primary outcome
Bowel related quality-of-life
Time frame: 3 months
5 secondary outcomes
Gastrointestinal toxicity
Time frame: During radiotherapy, at 3 and 6 months, then every 6 months after
Genitourinary toxicity
Time frame: During radiotherapy, at 3 and 6 months, then every 6 months after
PSA relapse rate
Time frame: 3 and 5 years
Patient Overall Quality of life
Time frame: During radiotherapy, at 3 and 6 months, then every 6 months after
Salvage androgen deprivation therapy rate
Time frame: 3 and 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
- Derived from this study: PubMed 40288917Ong WL, Quon H, Ong A, Cheung P, Chu W, Chung H, Vesprini D, Chowdhury A, Panjwani D, Alayed Y, Pang G, Korol R, Davidson M, Ravi A, McCurdy B, Zhang L, Kulasingham-Poon M, Mamedov A, Deabreu A, Loblaw A. Every Other Day or Once a Week: Long-term Oncological Outcomes in the Phase 2 PATRIOT Trial of Prostate Stereotactic Ablative Body Radiotherapy. Eur Urol Oncol. 2025 Aug;8(4):909-913. doi: 10.1016/j.euo.2025.03.011. Epub 2025 Apr 26.
- Derived from this study: PubMed 29551231Quon HC, Ong A, Cheung P, Chu W, Chung HT, Vesprini D, Chowdhury A, Panjwani D, Pang G, Korol R, Davidson M, Ravi A, McCurdy B, Zhang L, Mamedov A, Deabreu A, Loblaw A. Once-weekly versus every-other-day stereotactic body radiotherapy in patients with prostate cancer (PATRIOT): A phase 2 randomized trial. Radiother Oncol. 2018 May;127(2):206-212. doi: 10.1016/j.radonc.2018.02.029. Epub 2018 Mar 15.
- Individual participant dataSharing planned: Undecided
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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.
Aldrich Ong, MD principal investigator
CancerCare Manitoba
Andrew Loblaw, MD principal investigator
Sunnybrook Health Sciences Centre
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Image-guided radiotherapy in people with Prostatic Neoplasms, run by CancerCare Manitoba 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 3 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: finished, as of the sponsor's last update on 23 Feb 2024. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Bowel related quality-of-life (time frame: 3 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 NCT01423474, which also lists 2 linked publications.
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 23 Feb 2024.