Clinical trial · Interventional
Stereotactic Prostate Adaptive Radiotherapy Utilising Kilovoltage Intrafraction Monitoring
Stereotactic Prostate Adaptive Radiotherapy Utilising Kilovoltage Intrafraction
NCT02397317CI-TRIAL-00112054SPARKcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Multi-fraction SABR | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Multi-fraction SABR
- description
- All participants will receive Multi-Fraction SABR; 36.25 Gy (PTV D95) in 5 Fractions within 2-5 weeks
- interventionNames
- Radiation: Multi-fraction SABR
Primary outcomes (1)
- 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 (6)
- measure
- Patient treatment outcomes determined by assessing Biochemical-clinical failure (BCF)
- timeFrame
- up to a maximum of 36 months.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (3)
- DERIVEDChrystall 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. PMID 36963116
- DERIVEDHewson 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. PMID 32828839
- DERIVEDKeall 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. PMID 28270121