Data

TROG 15.01 SPARK Stereotactic Prostate Adaptive Radiotherapy utilising Kilovoltage intrafraction monitoring (SPARK)

Trans Tasman Radiation Oncology Group (TROG Cancer Research)

Dataset description

Dataset Contains: Changes in dosimetric coverage of the prostate and normal healthy structures with KIM, Patient treatment outcomes determined by assessing:, Biochemical-clinical failure (BCF), Acute and late toxicity grade 3 or higher (using CTCAE version 4), Patient-reported outcomes one and two years after treatment, patient and radiation therapist perception of KIM, and give guidelines on how the system could be improved, improvement in the overall beam-target accuracy., QOL data: (EPIC)-26 (Baseline, 2 weeks post RT, 6 weeks post RT, 12 months post RT, 36 months post RT), Imaging Data: Cone Beam Computed Tomorgraphy (CBCT) scan, Approx Time of data collection: 2016-2020 Radiotherapy Quality Assurance, 48 participants RT Plan, RT delivery and Imaging documentation, plus KIM data and RapidPlan models/RTQA feedback (DICOM format), 5 participants Benchmarking datasets

Date Information

Issued from 2023
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Source Study

Purpose

Treatment

Phase

Phase 2

Funding

Government body,Cancer Australia

Scientific enquiries

A/Prof Jarad Martin

Brief Summary

This study will determine the efficacy of the addition of Kilovoltage Intrafraction Monitoring during stereotactic prostate adaptive radiotherapy in prostate cancer patients. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have histologically proven prostate adenocarcinoma with low or intermediate disease risk. Study details All participants will receive multi-fraction stereotactic prostate adaptive radiotherapy at 36.25 Gy in 5 fractions over 2-5 week ....
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Key Inclusion Criteria

1. Histologically proven prostate adenocarcinoma 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 ....
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Key Exclusion Criteria

1. Lymph node irradiation 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 physicis ....
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Can healthy volunteers participate?

No

 

Population

Sample Size    49

Min. age    18 Years

Max. age    No limit

Sex    Males

Condition category    Prostate Cancer

Condition code    Cancer

Intervention

Intervention code Treatment: Devices , Treatment: Other

All participants will receive Multi-Fraction SABR; 36.25 Gy (PTV D95) in 5 Fractions within 2-5 weeks. The frequency and overall duration of SABR is determined at the discretion of the physician with patient consultation. Most linear accelerators used to treat cancer patients today are equipped with fixed X-ray imagers which are typically used to take images of a tumour before a patient receives radiotherapy. A new technology, known as Kilovoltage Intrafraction Monitoring (KIM), has recently eme ....
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Comparison

Control group Uncontrolled

This is not a controlled study in the sense of having an independent non-treated cohort. The patients are their own control.

Outcomes

Outcome: A dose accumulation method will be used to determine the efficacy of KIM, where the isodose distributions and dose volume histograms for each session will be calculated with Kilovoltage Intrafraction Monitoring (KIM) corrections as treated, and estimated without KIM corrections
Timepoint: After all patients have completed their final SABR treatment session

The data-sharing statement for this study is currently unavailable.

Source study information is derived from the Australian New Zealand Clinical Trials Registry (ANZCTR). For more information on the ANZCTR, please see anzctr.org.au