Stereotactic Prostate Adaptive Radiotherapy Utilising Kilovoltage Intrafraction Monitoring

NCT02397317 | Completed DMC

• 2 other identifiers: TROG 15.01 SPARKTROG 15.01
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 5

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.

Conditions

Prostate Cancer

Outcome Measures

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

  up to 36 months

Secondary Outcomes (6)

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

  up to a maximum of 36 months.

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

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

• Patient treatment outcomes determined by assessing patient-reported outcomes

  12 and 24 months after treatment

• 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.

  up to 36 months

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

  up to 36 months

Study Arms (1)

Multi-fraction SABR

EXPERIMENTAL

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

Radiation: Multi-fraction SABR

Interventions

Multi-fraction SABR RADIATION

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

Multi-fraction SABR

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically proven prostate adenocarcinoma
• 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)
• ECOG Performance status 0-2
• Suitable for definitive external beam radiotherapy (IMRT or VMAT)
• Ability to have three gold fiducial markers placed in the prostate
• Six month course of androgen deprivation therapy allowed at clinician discretion.
• Available for follow up for a minimum of 2 years (up to 3 years)

You may not qualify if:

• Lymph node irradiation
• Any other systemic anti-prostate cancer therapy (i.e. non-ADT) both proven in the metastatic setting and investigational (e.g. docetaxel, enzalutamide)
• Artificial hip(s) (Unable to visualise markers through prosthesis)
• Prostate volume \> 90 cm3 measured from the CT scan
• Patient lateral dimension \>40cm as measured at the level of the prostate from the CT scan
• Suboptimal fiducial markers placement for treatment utilising KIM as assessed by a medical physicist by measuring marker positions from the CT scan
• Fiducial migration or fewer than 3 fiducials present in the CT scan

Sponsors & Collaborators

• Trans Tasman Radiation Oncology Group: collaborator
• University of Sydney: lead

Study Sites (5)

Calvary Mater Newcastle

Newcastle, New South Wales, 2298, Australia

Location

Liverpool Cancer Therapy Centre

Sydney, New South Wales, 1871, Australia

Location

Royal North Shore Hospital

Sydney, New South Wales, 2065, Australia

Location

The Crown Princess Mary Cancer Centre Westmead

Sydney, New South Wales, 2145, Australia

Location

Peter MacCallum Cancer Centre

Melbourne, Victoria, 3000, Australia

Location

Related Publications (3)

• 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.

  PMID: 36963116 DERIVED

• 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.

  PMID: 32828839 DERIVED

• 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.

  PMID: 28270121 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Paul Keall

  University of Sydney

  STUDY CHAIR

• Jarad Martin

  Calvary Mater Newcastle

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2015
• First Posted: March 24, 2015
• Study Start: February 1, 2016
• Primary Completion: March 30, 2020
• Study Completion: June 19, 2020
• Last Updated: May 19, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

AU (5)