Stereotactic Prostate Adaptive Radiotherapy Utilising Kilovoltage Intrafraction Monitoring
NCT ID: NCT02397317
Last Updated: 2017-06-22
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
PHASE2
48 participants
INTERVENTIONAL
2016-02-29
2020-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Multi-fraction SABR
All participants will receive Multi-Fraction SABR; 36.25 Gy (PTV D95) in 5 Fractions within 2-5 weeks
Multi-fraction SABR
All participants will receive Multi-Fraction SABR; 36.25 Gy (PTV D95) in 5 Fractions within 2-5 weeks
Interventions
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Multi-fraction SABR
All participants will receive Multi-Fraction SABR; 36.25 Gy (PTV D95) in 5 Fractions within 2-5 weeks
Eligibility Criteria
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Inclusion Criteria
2. Low or intermediate risk disease as defined by:
* Low Risk: All of PSA\<10 ng/mL, Gleason Grade 6 AND Stage T1 or T2a
* Intermediate Risk: Any or all of PSA 10-20 ng/mL, Gleason Grade 7 OR Stage T2b-c
* Absence of high risk features (PSA\>20, T3-4, N1 or M1 disease, Gleason score 8-10) (PSA must be within 3 months prior to enrolment)
3. ECOG Performance status 0-2
4. Suitable for definitive external beam radiotherapy (IMRT or VMAT)
5. Ability to have three gold fiducial markers placed in the prostate
6. Six month course of androgen deprivation therapy allowed at clinician discretion.
7. Available for follow up for a minimum of 2 years (up to 3 years)
Exclusion Criteria
2. Any other systemic anti-prostate cancer therapy (i.e. non-ADT) both proven in the metastatic setting and investigational (e.g. docetaxel, enzalutamide)
3. Artificial hip(s) (Unable to visualise markers through prosthesis)
4. Prostate volume \> 90 cm3 measured from the CT scan
5. Patient lateral dimension \>40cm as measured at the level of the prostate from the CT scan
6. Suboptimal fiducial markers placement for treatment utilising KIM as assessed by a medical physicist by measuring marker positions from the CT scan
7. Fiducial migration or fewer than 3 fiducials present in the CT scan
18 Years
MALE
No
Sponsors
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Trans Tasman Radiation Oncology Group
OTHER
University of Sydney
OTHER
Responsible Party
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Principal Investigators
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Paul Keall
Role: STUDY_CHAIR
University of Sydney
Jarad Martin
Role: STUDY_CHAIR
Calvary Mater Newcastle
Locations
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Calvary Mater Newcastle
Newcastle, New South Wales, Australia
Liverpool Cancer Therapy Centre
Sydney, New South Wales, Australia
Royal North Shore Hospital
Sydney, New South Wales, Australia
The Crown Princess Mary Cancer Centre Westmead
Sydney, New South Wales, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
Countries
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Central Contacts
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Facility Contacts
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References
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Chrystall D, Mylonas A, Hewson E, Martin J, Keall P, Booth J, Nguyen DT. Deep learning enables MV-based real-time image guided radiation therapy for prostate cancer patients. Phys Med Biol. 2023 Apr 26;68(9). doi: 10.1088/1361-6560/acc77c.
Hewson EA, Nguyen DT, O'Brien R, Poulsen PR, Booth JT, Greer P, Eade T, Kneebone A, Hruby G, Moodie T, Hayden AJ, Turner SL, Hardcastle N, Siva S, Tai KH, Martin J, Keall PJ. Is multileaf collimator tracking or gating a better intrafraction motion adaptation strategy? An analysis of the TROG 15.01 stereotactic prostate ablative radiotherapy with KIM (SPARK) trial. Radiother Oncol. 2020 Oct;151:234-241. doi: 10.1016/j.radonc.2020.08.010. Epub 2020 Aug 20.
Keall P, Nguyen DT, O'Brien R, Booth J, Greer P, Poulsen P, Gebski V, Kneebone A, Martin J. Stereotactic prostate adaptive radiotherapy utilising kilovoltage intrafraction monitoring: the TROG 15.01 SPARK trial. BMC Cancer. 2017 Mar 8;17(1):180. doi: 10.1186/s12885-017-3164-1.
Other Identifiers
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TROG 15.01
Identifier Type: OTHER
Identifier Source: secondary_id
TROG 15.01 SPARK
Identifier Type: -
Identifier Source: org_study_id
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