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

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 .... 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 weeks. A new technology, known as Kilovoltage Intrafraction Monitoring (KIM), will be used which allows images of a tumour to be taken in real-time while the treatment is occurring. This enables strategies such as patient shifting or beam shifting during treatment which could potentially improve the accuracy of the treatment and reduce the patient’s side effects. In addition, due to the accuracy of KIM in targeting tumours, the number of treatment sessions this group of patients will require will be reduced to five as opposed to the 40 sessions required using more conventional treatment methods. Efficacy of KIM will be assessed by the dose accumulation method for each session. Participants will be followed for up to 2 years, in order to determine patient treatment outcomes, and toxicity. The researchers expect this trial to result in better targeted prostate cancer patient outcomes with lower toxicity. The potential application of KIM to other tumour sites will pave the way for additional trials with Australasian radiation oncology leading the world.
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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 .... 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 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) *if on anticoagulants, must be approved for procedure
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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 .... 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 physicist by measuring marker positions from the CT scan 7. Fiducial migration or fewer than 3 fiducials present in the CT scan
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