Prostate CancerpHART3NCT01578902
Hypofractionated Accelerated Radiotherapy for Low Risk Localized Prostate Cancer
A study testing Stereotactic ablative body radiotherapy in people with Prostate Cancer, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial summary
The purpose of this study is to determine the safety and efficacy of a short course of radiotherapy (35 Gy / 5 fractions / 29 days) for the treatment of low-risk 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?
- Stereotactic ablative body radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2006to Apr 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Informed consent signed (Appendix A)
- Adult men greater than 18 years of age
- Histologically confirmed diagnosis of adenocarcinoma of the prostate (centrally reviewed).
- Clinical stage T1-T2b, Gleason Score < 6, and PSA < 10 ng/mL
- Less than 50% of biopsy cores +ve for cancer
- Less than 50% overall surface area involved with cancer
- Neoadjuvant hormone suppression therapy is allowed. However, PSA, must have been performed within 2 months of starting androgen suppression therapy. If androgen suppression therapy has been started LHRH agonist must be continued for a minimum of 3 months before initiation of gold fiducial marker insertion \& radiotherapy planning.
Who cannot join
- Prior pelvic radiotherapy.
- Concurrent anticoagulation medication (if it is unsafe to discontinue for gold seed insertion)
- Diagnosis of bleeding diathesis
- Presence of a hip prosthesis
- Pelvic girth >40cm (to ensure visibility of gold seeds on electronic portal imaging device)
- Large prostate (> 60 cm3) on imaging
- Severe lower urinary tract symptoms (International Prostate Symptom Score > 15 or nocturia > 3)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hypofractionated Accelerated Radiotherapy for Low Risk Localized Prostate Cancer (pHART 3)
The purpose of this study is to determine the safety and efficacy of a short course of radiotherapy (35 Gy / 5 fractions / 29 days) for the treatment of low-risk prostate cancer.
Read the detailed description
Rationale for Proposed Study With the availability of intensity modulated radiotherapy (IMRT) at the Odette Cancer Centre (OCC), there is an opportunity to explore the use of a much more intensive hypofractionation schedule for prostate cancer. Using an alpha/beta ratio of 1.3, a dose of 35 Gy in 5 fractions would be equivalent to 88 Gy delivered in 2 Gy fractions. For normal tissues (alpha/beta value of 2), this would be equivalent to 78 Gy in 2 Gy fractions. As such, the linear quadratic equation predicts that 35 Gy in 5 fractions should not result in any increased late toxicity for normal tissues compared to standard dose escalated radiotherapy. However, the biological dose to the prostate cancer would be significantly increased. As a safety precaution for this study proposal, the investigators propose to deliver 35 Gy in 5 fractions over 5 weeks (one radiotherapy fraction of 7 Gy per week) to allow for normal tissue repair.
With IMRT, it is expected that there will be superior conformality of the high dose region around the target volume. As well, the use of daily on-line imaging will allow us to eliminate interfraction prostate motion errors and use tighter planning target volume margins for any residual intrafraction motion. At OCC, such an approach has already been shown to be feasible and is currently employed in the phase 1/2 concomitant boost study for high risk prostate cancer.
If proven to be safe and effective, such a hypofractionated radiotherapy schedule may have significant practical advantages as well. With only 1 fraction of radiotherapy delivered each week (for a total of 5 weeks), there are huge savings in resource utilization and increased convenience for patients.
The investigators propose to start a small phase 1 study to explore the use of this dose fractionation for men with low risk prostate cancer. The primary endpoint for this small pilot study would be acute and late normal tissue toxicities. If proven to be feasible and safe, external peer-reviewed funding will be sought to further explore this novel treatment schedule in a larger phase 2 setting.
- Conditions
- Prostate Cancer
- Being tested
- Stereotactic ablative body radiotherapy
- Keywords
- Prostatic Neoplasms, Radiotherapy, Hypofractionation, Low Risk Prostate Cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic ablative body radiotherapyRadiation
Also called standard linear accelerator delivery
35Gy/5 fractions/29 days
| Study group | Role | What they receive |
|---|---|---|
| Hypofractionated radiotherapy using SABR | Experimental | Stereotactic radiation: 35Gy in 5 fractions over 29 days Receives: Radiation: Stereotactic ablative body radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Grade 3+ Gastrointestinal Toxicity
Common Terminology Criteria for Adverse Events (CTCAE) v3.0
Measured: Acute period (up to 6 months)
Secondary outcomes (5)
Incidence of Grade 3+ Genitourinary Toxicity
Common Terminology Criteria for Adverse Events (CTCAE) v3.0
Measured: Acute (up to 6 months) and Late (6 months and after)
Incidence of Grade 3+ Rectal and Urinary Toxicity
Common Terminology Criteria for Adverse Events (CTCAE) v3.0
Measured: Late (6 months and after)
Patient Reported Quality of Life
Expanded Prostate Cancer Index Composite (EPIC)
Measured: up to 5 years
Biochemical (ie. Prostate Specific Antigen) Disease Free Survival
Failure = Follow-up PSA greater than nadir PSA + 2 ng/ml
Measured: 5 year
Biopsy Positive Rate
Patients were biopsied at 3 years post treatment
Measured: 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2012 (estimated)
- Study startOct 2006
- Primary completionApr 2008
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Association of Radiation Oncology
- Responsible party
- Sponsor
- Investigators
- Andrew Loblaw, MD, Principal investigator, Sunnybrook Health Sciences CentrePatrick Cheung, MD, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01578902
- Sponsor's protocol ID
- 371-2006
- Acronym
- pHART3
- Status last verified
- Nov 2020
- First submitted
- 31 Oct 2011
- Last updated
- 17 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Quon HC, Musunuru HB, Cheung P, Pang G, Mamedov A, D'Alimonte L, Deabreu A, Zhang L, Loblaw A. Dose-Escalated Stereotactic Body Radiation Therapy for Prostate Cancer: Quality-of-Life Comparison of Two Prospective Trials. Front Oncol. 2016 Aug 29;6:185. doi: 10.3389/fonc.2016.00185. eCollection 2016.
PubMed 27622157
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypofractionated Accelerated Radiotherapy for Low Risk Localized Prostate Cancer (pHART 3)
- ClinicalTrials.gov ID
- NCT01578902
- Acronym / sponsor ID
- pHART3 / 371-2006
- Conditions
- Prostate Cancer
- Keywords
- Prostatic Neoplasms, Radiotherapy, Hypofractionation, Low Risk Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Collaborators
- Canadian Association of Radiation Oncology
- Study start
- Oct 2006
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 17 Apr 2012 (estimated)
- Results
- Posted 17 Dec 2020
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 determine the safety and efficacy of a short course of radiotherapy (35 Gy / 5 fractions / 29 days) for the treatment of low-risk prostate cancer.
Detailed description
Rationale for Proposed Study With the availability of intensity modulated radiotherapy (IMRT) at the Odette Cancer Centre (OCC), there is an opportunity to explore the use of a much more intensive hypofractionation schedule for prostate cancer. Using an alpha/beta ratio of 1.3, a dose of 35 Gy in 5 fractions would be equivalent to 88 Gy delivered in 2 Gy fractions. For normal tissues (alpha/beta value of 2), this would be equivalent to 78 Gy in 2 Gy fractions. As such, the linear quadratic equation predicts that 35 Gy in 5 fractions should not result in any increased late toxicity for normal tissues compared to standard dose escalated radiotherapy. However, the biological dose to the prostate cancer would be significantly increased. As a safety precaution for this study proposal, the investigators propose to deliver 35 Gy in 5 fractions over 5 weeks (one radiotherapy fraction of 7 Gy per week) to allow for normal tissue repair.
With IMRT, it is expected that there will be superior conformality of the high dose region around the target volume. As well, the use of daily on-line imaging will allow us to eliminate interfraction prostate motion errors and use tighter planning target volume margins for any residual intrafraction motion. At OCC, such an approach has already been shown to be feasible and is currently employed in the phase 1/2 concomitant boost study for high risk prostate cancer.
If proven to be safe and effective, such a hypofractionated radiotherapy schedule may have significant practical advantages as well. With only 1 fraction of radiotherapy delivered each week (for a total of 5 weeks), there are huge savings in resource utilization and increased convenience for patients.
The investigators propose to start a small phase 1 study to explore the use of this dose fractionation for men with low risk prostate cancer. The primary endpoint for this small pilot study would be acute and late normal tissue toxicities. If proven to be feasible and safe, external peer-reviewed funding will be sought to further explore this novel treatment schedule in a larger phase 2 setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hypofractionated radiotherapy using SABR | Experimental | Radiation: Stereotactic ablative body radiotherapyStereotactic radiation: 35Gy in 5 fractions over 29 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Informed consent signed (Appendix A)
- Adult men greater than 18 years of age
- Histologically confirmed diagnosis of adenocarcinoma of the prostate (centrally reviewed).
- Clinical stage T1-T2b, Gleason Score < 6, and PSA < 10 ng/mL
- Less than 50% of biopsy cores +ve for cancer
Key exclusion criteria (7 listed)
- Prior pelvic radiotherapy.
- Concurrent anticoagulation medication (if it is unsafe to discontinue for gold seed insertion)
- Diagnosis of bleeding diathesis
- Presence of a hip prosthesis
- Pelvic girth >40cm (to ensure visibility of gold seeds on electronic portal imaging device)
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 |
|---|---|---|
| Stereotactic ablative body radiotherapyAlso: standard linear accelerator delivery35Gy/5 fractions/29 days | Radiation | Hypofractionated radiotherapy using SABR |
Primary outcome
Incidence of Grade 3+ Gastrointestinal Toxicity
Time frame: Acute period (up to 6 months)
Common Terminology Criteria for Adverse Events (CTCAE) v3.0
5 secondary outcomes
Incidence of Grade 3+ Genitourinary Toxicity
Time frame: Acute (up to 6 months) and Late (6 months and after)
Incidence of Grade 3+ Rectal and Urinary Toxicity
Time frame: Late (6 months and after)
Patient Reported Quality of Life
Time frame: up to 5 years
Biochemical (ie. Prostate Specific Antigen) Disease Free Survival
Time frame: 5 year
Biopsy Positive Rate
Time frame: 3 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27622157Quon HC, Musunuru HB, Cheung P, Pang G, Mamedov A, D'Alimonte L, Deabreu A, Zhang L, Loblaw A. Dose-Escalated Stereotactic Body Radiation Therapy for Prostate Cancer: Quality-of-Life Comparison of Two Prospective Trials. Front Oncol. 2016 Aug 29;6:185. doi: 10.3389/fonc.2016.00185. eCollection 2016.
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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.
Andrew Loblaw, MD principal investigator
Sunnybrook Health Sciences Centre
Patrick Cheung, MD principal investigator
Sunnybrook Health Sciences 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 Stereotactic ablative body radiotherapy in people with Prostate Cancer, run by Sunnybrook Health Sciences Centre 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 7 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 17 Dec 2020. 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?
Yes. Results are posted in the registry (first posted 17 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Incidence of Grade 3+ Gastrointestinal Toxicity (time frame: Acute period (up to 6 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 NCT01578902, 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 17 Dec 2020.