Prostate CancerRCT-PHART2NCT04239599
Trial of Hypofractionated IMRT Boost Versus Conventional IMRT Boost for Localized High Risk Prostate Cancer
A study testing Hypofractionated IMRT Radiation treatment in people with Prostate Cancer, run by Sunnybrook Health Sciences Centre.
Trial summary
Hypofractionation: 48 Gy in 25 fractions to pelvic lymph nodes while the prostate receives 68 Gy in 25 fractions concomitantly. Standard Fractionation: pelvic lymph nodes and prostate will initially be treated to 46 Gy in 23 fractions, followed by a subsequent boost to the prostate to a total dose of 78 Gy over 39… 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?
- Hypofractionated IMRT Radiation treatment
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- No sites listed yet
- Study dates
- 31 Mar 2011to 31 Dec 2023
- 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
- Written informed consent obtained.
- Histologically confirmed diagnosis of adenocarcinoma of the prostate.
- Clinical stage T1-2 N0 M0, Gleason Score ≤ 7, PSA 20 - 100
- T1-2 N0 M0, Gleason Score 8 - 10, PSA ≤ 100
- T3 N0 M0, any Gleason Score, PSA ≤ 100
Who cannot join
- Patients with unilateral or bilateral hip replacement.
- Patients with active collagen vascular disease.
- Patients with active inflammatory bowel disease.
- Patients with previous radiotherapy to the pelvis.
- Patients with ataxia telangiectasia.
- Patients with nodal or distant metastases
About this study
Official title: Randomized Trial of Concomitant Hypofractionated IMRT Boost Versus Conventional Fractionated IMRT Boost for Localized High Risk Prostate Cancer
Hypofractionation: 48 Gy in 25 fractions to pelvic lymph nodes while the prostate receives 68 Gy in 25 fractions concomitantly.
Standard Fractionation: pelvic lymph nodes and prostate will initially be treated to 46 Gy in 23 fractions, followed by a subsequent boost to the prostate to a total dose of 78 Gy over 39 fractions.
Read the detailed description
Half the participants will receive using a one phase IMRT plan, the pelvic lymph nodes will be treated to a dose of 48 Gy in 25 fractions, while the prostate will be treated to a dose of 68 Gy in 25 fractions concomitantly (simulataneous integrated boost).
The other half of the participants will receive Standard fractionation using 2 sequential IMRT plans, the pelvic lymph nodes and prostate will initially be treated to 46 Gy in 23 fractions, followed by a subsequent boost to the prostate to a total dose of 78 Gy.
- Conditions
- Prostate Cancer
- Being tested
- Hypofractionated IMRT Radiation treatment
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypofractionated IMRT Radiation treatmentRadiation
Also called Eligard 22.5 mg (28.2 mg leuprolide acetate per syringe) [3-Month] for 18-36 months
| Study group | Role | What they receive |
|---|---|---|
| Hypofractionation | Experimental | Hypofractionation: Using a one phase IMRT plan, the pelvic lymph nodes will be treated to a dose of 48 Gy in 25 fractions, while the prostate will be treated to a dose of 68 Gy in 25 fractions concomitantly (simulataneous integrated boost) + 18-36 months of Eligard Hormone injection. Receives: Radiation: Hypofractionated IMRT Radiation treatment |
| Standard Fractination | Active comparator | Using 2 sequential IMRT plans, the pelvic lymph nodes and prostate will initially be treated to 46 Gy in 23 fractions, followed by a subsequent boost to the prostate to a total dose of 78 Gy + 18-36 months of Eligard Hormone injection. Receives: Radiation: Hypofractionated IMRT Radiation treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease free survival
The primary outcome for this study is PSA biochemical disease free survival at 5 years.
Measured: 5 years
Secondary outcomes (4)
Late GI and GU toxicities
Number of participants with treatment-related adverse events as assessed by CTCAE v3.0, change from 6 months post treatment to end of 5 year follow-up.
Measured: 6 month post completion of treatment to end of 5 year follow up
Quality of life outcome: Expanded Prostate Index Composite (EPIC)
Measuring quality of life using the Expanded Prostate Cancer Index Composite (EPIC) questionnaire. The EPIC questionnaire consists of 50 questions. Each question is scored from 1-5, 5 being the better outcome and 1 being the worst outcome in most of the questions
Measured: Baseline (start of treatment) to end of 5 year follow-up
Overall survival
Overall survival comparing two treatment arms
Measured: Baseline to end of 5 year follow-up
Cancer specific survival
Cancer specific survival comparing two treatment arms
Measured: Baseline to end of 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 posted27 Jan 2020
- Study start31 Mar 2011
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (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 Sunnybrook Health Sciences CentreThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Responsible party
- Sponsor
- Investigators
- Patrick Cheung, MD, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04239599
- Sponsor's protocol ID
- RCT- PHART2
- Acronym
- RCT-PHART2
- Status last verified
- Sep 2022
- First submitted
- 29 Oct 2019
- Last updated
- 29 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share Individual Participant data. Results from the trial will be available through publications.
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Concomitant Hypofractionated IMRT Boost Versus Conventional Fractionated IMRT Boost for Localized High Risk Prostate Cancer
- ClinicalTrials.gov ID
- NCT04239599
- Acronym / sponsor ID
- RCT-PHART2 / RCT- PHART2
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 178 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Collaborators
- Sanofi
- Study start
- 31 Mar 2011
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 27 Jan 2020 (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.
Hypofractionation: 48 Gy in 25 fractions to pelvic lymph nodes while the prostate receives 68 Gy in 25 fractions concomitantly.
Standard Fractionation: pelvic lymph nodes and prostate will initially be treated to 46 Gy in 23 fractions, followed by a subsequent boost to the prostate to a total dose of 78 Gy over 39 fractions.
Detailed description
Half the participants will receive using a one phase IMRT plan, the pelvic lymph nodes will be treated to a dose of 48 Gy in 25 fractions, while the prostate will be treated to a dose of 68 Gy in 25 fractions concomitantly (simulataneous integrated boost).
The other half of the participants will receive Standard fractionation using 2 sequential IMRT plans, the pelvic lymph nodes and prostate will initially be treated to 46 Gy in 23 fractions, followed by a subsequent boost to the prostate to a total dose of 78 Gy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypofractionation | Experimental | Radiation: Hypofractionated IMRT Radiation treatmentHypofractionation: Using a one phase IMRT plan, the pelvic lymph nodes will be treated to a dose of 48 Gy in 25 fractions, while the prostate will be treated to a dose of 68 Gy in 25 fractions concomitantly (simulataneous integrated boost) + 18-36 months of Eligard Hormone injection. |
| Standard Fractination | Active comparator | Radiation: Hypofractionated IMRT Radiation treatmentUsing 2 sequential IMRT plans, the pelvic lymph nodes and prostate will initially be treated to 46 Gy in 23 fractions, followed by a subsequent boost to the prostate to a total dose of 78 Gy + 18-36 months of Eligard Hormone injection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Written informed consent obtained.
- Histologically confirmed diagnosis of adenocarcinoma of the prostate.
- Clinical stage T1-2 N0 M0, Gleason Score ≤ 7, PSA 20 - 100
- T1-2 N0 M0, Gleason Score 8 - 10, PSA ≤ 100
- T3 N0 M0, any Gleason Score, PSA ≤ 100
Key exclusion criteria (6 listed)
- Patients with unilateral or bilateral hip replacement.
- Patients with active collagen vascular disease.
- Patients with active inflammatory bowel disease.
- Patients with previous radiotherapy to the pelvis.
- Patients with ataxia telangiectasia.
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 |
|---|---|---|
| Hypofractionated IMRT Radiation treatmentAlso: Eligard 22.5 mg (28.2 mg leuprolide acetate per syringe) [3-Month] for 18-36 months | Radiation | Hypofractionation, Standard Fractination |
Primary outcome
Disease free survival
Time frame: 5 years
The primary outcome for this study is PSA biochemical disease free survival at 5 years.
4 secondary outcomes
Late GI and GU toxicities
Time frame: 6 month post completion of treatment to end of 5 year follow up
Quality of life outcome: Expanded Prostate Index Composite (EPIC)
Time frame: Baseline (start of treatment) to end of 5 year follow-up
Overall survival
Time frame: Baseline to end of 5 year follow-up
Cancer specific survival
Time frame: Baseline to end of 5 year follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2022.
- Individual participant dataSharing planned: No. There is no plan to share Individual Participant data. Results from the trial will be available through publications.
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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.
Patrick Cheung, MD principal investigator
Sunnybrook Health Sciences Centre
Questions about this trial
What is this clinical trial studying?
A study testing Hypofractionated IMRT Radiation treatment in people with Prostate Cancer, run by Sunnybrook Health Sciences Centre.
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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 29 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Disease free survival (time frame: 5 years). 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 29 Sep 2022.