Clinical trial NCT02397317: Stereotactic Prostate Adaptive Radiotherapy Utilising Kilovoltage Intrafraction Monitoring
Official title: Stereotactic Prostate Adaptive Radiotherapy Utilising Kilovoltage Intrafraction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Prostate Cancer
Lead sponsor: University of Sydney
Sponsor class: OTHER
Collaborators: name: Trans Tasman Radiation Oncology Group
First posted: 2015-03-24
Enrollment: 48
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The SPARK trial is testing the use of Kilovoltage Intrafraction Monitoring in prostate cancer patients being treated with Stereotactic Prostate Adaptive Radiotherapy. The researchers expect this trial to result in better targeted prostate cancer patient outcomes with lower toxicity. The potential application of Kilovoltage Intrafraction Monitoring to other tumour sites will pave the way for additional trials with Australasian radiation oncology leading the world.

Detailed description: 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 has recently emerged which allows images of a tumour to be taken in real-time while the treatment is occurring. The advantage of Kilovoltage Intrafraction Monitoring is that it 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 Kilovoltage Intrafraction Monitoring 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.

Eligibility criteria: 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 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:

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

Primary outcomes:
measure: Accumulated patient dose distributions will be determined via paired controls by comparing the measured treatment accuracy and dose with KIM and those that would have been delivered in the absence of KIM
timeFrame: up to 36 months
Secondary outcomes:
measure: Patient treatment outcomes determined by assessing Biochemical-clinical failure (BCF)
timeFrame: up to a maximum of 36 months.
measure: Patient treatment outcomes determined by assessing acute and late toxicity grade 3 or higher (using CTCAE version 4)
timeFrame: Weekly during treatment, then two weeks, six weeks and 6 months post treatment
measure: Patient treatment outcomes determined by assessing patient-reported outcomes
timeFrame: 12 and 24 months after treatment
measure: The patient's perception of KIM will be quantified using an adapted SAT-RAR survey, an instrument that has previously been used to assess patient perceptions on technological innovations in radiotherapy and respiratory gating.
timeFrame: up to 36 months
measure: Targeting accuracy through measuring the final geometric accuracy with and without the KIM gating procedure
timeFrame: up to 36 months
measure: Radiation therapists feedback on KIM will be quantified using a survey which will obtain specific information about the impact of the KIM system and SPARK on education, patient workflow, clinical impact and user confidence
timeFrame: up to 36 months
Other outcomes:
Locations:
city: Newcastle
country: Australia
facility: Calvary Mater Newcastle
state: New South Wales
city: Sydney
country: Australia
facility: Liverpool Cancer Therapy Centre
state: New South Wales
city: Sydney
country: Australia
facility: Royal North Shore Hospital
state: New South Wales
city: Sydney
country: Australia
facility: The Crown Princess Mary Cancer Centre Westmead
state: New South Wales
city: Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre
state: Victoria
Study officials:
affiliation: University of Sydney
name: Paul Keall
role: STUDY_CHAIR
affiliation: Calvary Mater Newcastle
name: Jarad Martin
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.