Hypofractionated Accelerated Radiotherapy for Low Risk Localized Prostate Cancer
NCT ID: NCT01578902
Last Updated: 2020-12-17
Study Results
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View full resultsBasic Information
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COMPLETED
NA
84 participants
INTERVENTIONAL
2006-10-31
2013-04-30
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Hypofractionated radiotherapy using SABR
Stereotactic radiation: 35Gy in 5 fractions over 29 days
Stereotactic ablative body radiotherapy
35Gy/5 fractions/29 days
Interventions
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Stereotactic ablative body radiotherapy
35Gy/5 fractions/29 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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)
18 Years
MALE
No
Sponsors
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Canadian Association of Radiation Oncology
INDUSTRY
Sunnybrook Health Sciences Centre
OTHER
Responsible Party
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Principal Investigators
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Andrew Loblaw, MD
Role: PRINCIPAL_INVESTIGATOR
Sunnybrook Health Sciences Centre
Patrick Cheung, MD
Role: PRINCIPAL_INVESTIGATOR
Sunnybrook Health Sciences Centre
Locations
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Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Countries
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References
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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.
Other Identifiers
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371-2006
Identifier Type: -
Identifier Source: org_study_id