SPARK
ACTRN12615000335594
Treatment
Phase 2
Government body,Cancer Australia
A/Prof Jarad Martin
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 .... Read more
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 .... Read more
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 .... Read more
No
Sample Size 49
Min. age 18 Years
Max. age No limit
Sex Males
Condition category Prostate Cancer
Condition code Cancer
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 .... Read more
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.
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 correctionsTimepoint: After all patients have completed their final SABR treatment session