Stereotactic MRI-Guided Radiation for Localized Prostate Cancer
NCT ID: NCT03588819
Last Updated: 2022-06-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
30 participants
INTERVENTIONAL
2018-04-23
2024-04-23
Brief Summary
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Detailed Description
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13 Gy to whole prostate +/- seminal vesicles AND Up to 16 Gy simultaneous boost to dominant MRI nodule
Treatment Delivery and Quality Assurance Treatment will be delivered on treatment units equipped with with volumetric arc therapy and hexapod couches. Only photons with megavoltage energies of 6 MV will be used. Cone-beam CT imaging will be performed using the implanted fiducials to set up each treatment. Imaging after each fraction of radiation will be performed and the shifts in prostate positioning (as measured by displacement of gold seed fiducials) will be measured and recorded. Also, the total treatment time for each fraction of radiotherapy will be recorded.
Patient Assessments / Follow-up Time zero will be the start of radiotherapy. Baseline and follow-up parameters are as listed in Appendix A. Baseline rectal and urinary function will be recorded. Acute toxicities will be assessed at weeks 1, 4, and 13 and late toxicities will be assessed at month 6 and every 6 months until year 5 using the Common Terminology Criteria Adverse Events, version 4.0. Bloodwork (PSA and testosterone), will be performed at months 3, 6 and every 6 months until year 5. QOL using the Expanded Prostate Cancer Index Composite (EPIC) will be obtained at baseline, weeks 1, 4, 13, month 6 and every 6 months until year 5.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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2-fraction SABR
SABR
26 Gy in 2 fractions to the prostate and DIL dose of up to 32 Gy in 2 fractions of MR-guided SABR delivered 1 week apart
Interventions
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SABR
26 Gy in 2 fractions to the prostate and DIL dose of up to 32 Gy in 2 fractions of MR-guided SABR delivered 1 week apart
Eligibility Criteria
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Inclusion Criteria
2. Men \>18 years
3. Histologically confirmed prostate adenocarcinoma (centrally reviewed)
4. Favorable risk prostate cancer, defined as clinical stage T1-2c, Gleason Sum less than or equal to 7, and PSA less than or equal to 20 ng/mL (patients can have only one of T2c, Gleason Sum 7 and PSA 10-20 ng/ml)
Exclusion Criteria
2. Prior pelvic radiotherapy
3. Anticoagulation medication (if unsafe to discontinue for gold seed insertion)
4. Diagnosis of bleeding diathesis
5. Large prostate (\>90cm3) on imaging
6. Immunosuppressive medications
7. Inflammatory bowel disease
8. Presence of a hip prosthesis
9. Contraindications to having MRI
18 Years
MALE
No
Sponsors
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Sunnybrook Health Sciences Centre
OTHER
Responsible Party
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Andrew Loblaw
GU Radiation Oncology Team Lead
Principal Investigators
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Andrew Loblaw, MD, FRCPC
Role: PRINCIPAL_INVESTIGATOR
Sunnybrook Health Sciences Centre, University of Toronto
Locations
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Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Countries
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References
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Ong WL, Cheung P, Chung H, Chu W, Detsky J, Liu S, Morton G, Szumacher E, Tseng CL, Vesprini D, Davidson M, Ravi A, McGuffin M, Zhang L, Mamedov A, Deabreu A, Kulasingham-Poon M, Loblaw A. To Boost or Not to Boost: Pooled Analyses From 2-Fraction SABR Trials for Localized Prostate Cancer. Int J Radiat Oncol Biol Phys. 2023 Dec 1;117(5):1153-1162. doi: 10.1016/j.ijrobp.2023.06.250. Epub 2023 Jul 5.
Other Identifiers
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014-2018
Identifier Type: -
Identifier Source: org_study_id
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