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CompletedNCT02397317SPARKUpdated May 19, 2026

Stereotactic Prostate Adaptive Radiotherapy Utilising Kilovoltage Intrafraction Monitoring

An interventional study of Multi-fraction SABR in Prostate Cancer, sponsored by University of Sydney. Completed at 5 sites in Australia. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-19.

Sponsored by University of Sydney · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
49
Allocation
Not applicable
Ages
18 Years and older
Sex
Male
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Study 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.

Read the 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.

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Conditions studied

  • Prostate Cancer

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In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

This study's enrollment of 49 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

University of Sydney is the lead sponsor of 91 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
49 participants (actual)

Study arms

  • Experimental
    Multi-fraction SABR

    All participants will receive Multi-Fraction SABR; 36.25 Gy (PTV D95) in 5 Fractions within 2-5 weeks

    Radiation: Multi-fraction SABR

Interventions

  • RadiationMulti-fraction SABR

    All participants will receive Multi-Fraction SABR; 36.25 Gy (PTV D95) in 5 Fractions within 2-5 weeks

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What researchers measure

Primary outcomes

  1. 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

    Time frame: up to 36 months

Secondary outcomes

  1. Patient treatment outcomes determined by assessing Biochemical-clinical failure (BCF)

    Time frame: up to a maximum of 36 months.

  2. Patient treatment outcomes determined by assessing acute and late toxicity grade 3 or higher (using CTCAE version 4)

    Time frame: Weekly during treatment, then two weeks, six weeks and 6 months post treatment

  3. Patient treatment outcomes determined by assessing patient-reported outcomes

    Time frame: 12 and 24 months after treatment

  4. 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.

    Time frame: up to 36 months

  5. Targeting accuracy through measuring the final geometric accuracy with and without the KIM gating procedure

    Time frame: up to 36 months

  6. 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

    Time frame: up to 36 months

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Study locations

5 sites
  • Calvary Mater Newcastle
    Newcastle, New South Wales 2298, Australia
  • Liverpool Cancer Therapy Centre
    Sydney, New South Wales 1871, Australia
  • Royal North Shore Hospital
    Sydney, New South Wales 2065, Australia
  • The Crown Princess Mary Cancer Centre Westmead
    Sydney, New South Wales 2145, Australia
  • Peter MacCallum Cancer Centre
    Melbourne, Victoria 3000, Australia
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References and documents

Publications

  • Chrystall 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. PubMed 36963116 ↗
  • 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. PubMed 32828839 ↗
  • 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. PubMed 28270121 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 19, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02397317
Lead sponsor
University of Sydney
Collaborators
Trans Tasman Radiation Oncology Group
Responsible party
Sponsor
First posted
Mar 24, 2015
Start date
Feb 2016
Primary completion
Mar 30, 2020
Completion
Jun 19, 2020
Last update
May 19, 2026

Study contacts

Paul Keall
study chair · University of Sydney
Jarad Martin
study chair · Calvary Mater Newcastle

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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