Prostate CancerNCT03526510
Hypofractionated Boost vs Conventionally Fractionated Boost for Localized High Risk Prostate Cancer
A study testing Conventionally Fractionated versus Hypofractionated Boost in people with Prostate Cancer, run by Dr. Patrick Cheung at 1 site in Canada.
Trial summary
Randomized trial comparing 2 external beam radiotherapy fractionation schemes in patients with localized high risk prostate cancer. Primary endpoint is acute toxicity. 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 versus Hypofractionated Boost
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2011to Dec 2024
- 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.
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Trial of Concomitant Hypofractionated IMRT Boost Versus Conventional Fractionated IMRT Boost for Localized High Risk Prostate Cancer
Randomized trial comparing 2 external beam radiotherapy fractionation schemes in patients with localized high risk prostate cancer. Primary endpoint is acute toxicity.
Read the detailed description
Patients enrolled onto this study will be randomized to one of the following treatment arms:
- 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.
- 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).
In addition, all patients receive 1.5- 3 years of androgen deprivation therapy.
- Conditions
- Prostate Cancer
- Being tested
- Conventionally Fractionated versus Hypofractionated Boost
- Keywords
- High Risk Prostate Cancer, Radiotherapy
- 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 versus Hypofractionated BoostRadiation
| Study group | Role | What they receive |
|---|---|---|
| Standard Fractionation | 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. Receives: Radiation: Conventionally Fractionated versus Hypofractionated Boost |
| Hypofractionation | Experimental | 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). Receives: Radiation: Conventionally Fractionated versus Hypofractionated Boost |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute Toxicity
Proportion of patients experiencing grade >=2 acute toxicity
Measured: within 3 months after starting radiotherapy
Secondary outcomes (3)
Late Toxicity
Proportion of patients experiencing grade >= 2 late toxicity
Measured: beyond 3 months of starting radiotherapy
Biochemical Control (Phoenix Definition)
Actuarial measure of patients failing biochemically (defined as PSA nadir + 2 ng/mL)
Measured: at 5 years
Overall Survival
Actuarial measure of patients being alive
Measured: at 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2018
- Study startJun 2011
- Primary completionNov 2021
- Study completionDec 2024 (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.
- 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
- Model description
- Randomized Trial
- Masking
- None (open label)
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Patrick Cheung
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Patrick Cheung, Sunnybrook Health Sciences Centre
- Investigators
- Patrick Cheung, MD, Study chair, Toronto Sunnybrook Regional Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03526510
- Sponsor's protocol ID
- pHART2 RCT
- Status last verified
- Mar 2022
- First submitted
- 3 May 2018
- Last updated
- 8 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 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
- NCT03526510
- Acronym / sponsor ID
- pHART2 RCT
- Conditions
- Prostate Cancer
- Keywords
- High Risk Prostate Cancer, Radiotherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 178 participants (actual)
- Lead sponsor
- Dr. Patrick CheungUniversity, hospital or other
- Study start
- Jun 2011 (actual)
- Primary completion
- Nov 2021 (actual)
- Study completion
- Dec 2024 (estimated)
- First posted
- 16 May 2018 (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.
Randomized trial comparing 2 external beam radiotherapy fractionation schemes in patients with localized high risk prostate cancer. Primary endpoint is acute toxicity.
Detailed description
Patients enrolled onto this study will be randomized to one of the following treatment arms:
- 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.
- 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).
In addition, all patients receive 1.5- 3 years of androgen deprivation therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Trial
| Arm | Type | Receives |
|---|---|---|
| Standard Fractionation | Active comparator | Radiation: Conventionally Fractionated versus Hypofractionated BoostUsing 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. |
| Hypofractionation | Experimental | Radiation: Conventionally Fractionated versus Hypofractionated BoostUsing 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). |
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.
- 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 |
|---|---|---|
| Conventionally Fractionated versus Hypofractionated Boost | Radiation | Hypofractionation, Standard Fractionation |
Primary outcome
Acute Toxicity
Time frame: within 3 months after starting radiotherapy
Proportion of patients experiencing grade >=2 acute toxicity
3 secondary outcomes
Late Toxicity
Time frame: beyond 3 months of starting radiotherapy
Biochemical Control (Phoenix Definition)
Time frame: at 5 years
Overall Survival
Time frame: at 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2022.
- Individual participant dataSharing planned: No
Related trials for Prostate Cancer
Not yet recruitingObservational study
Assessment of Intelligent Algorithms for Detection, Diagnosis and Risk Stratification of Tumors of the Kidney and Prostate
Kidney Cancers, Prostate Cancer
Not yet recruiting
WATER IV PCa (AS Sub-study)
Localized Prostate Cancer
Recruiting
The Application of Somatosensory Interactive Pelvic Floor Muscle Training for Stress Urinary Incontinence in Men Underwent Radical Prostatectomy
Prostate Cancer (Post Prostatectomy)
RecruitingPhase 1
A Study of [225Ac]Ac-AKY-2519 in Patients With Metastatic Castration-Resistant Prostate Cancer
Castration Resistant Metastatic Prostate Cancer, Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
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 study chair
Toronto Sunnybrook Regional Cancer Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventionally Fractionated versus Hypofractionated Boost in people with Prostate Cancer, run by Dr. Patrick Cheung 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 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 8 Mar 2022. 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?
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?
Acute Toxicity (time frame: within 3 months after starting radiotherapy). 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 8 Mar 2022.