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Stereotactic Prostate Adaptive Radiotherapy Utilising Kilovoltage Intrafraction Monitoring (SPARK)

Primary Purpose

Prostate Cancer

Status

Unknown status

Phase

Phase 2

Locations

Australia

Study Type

Interventional

Intervention

Multi-fraction SABR

About this trial

This is an interventional treatment trial for Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

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)

Exclusion Criteria:

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

Sites / Locations

Calvary Mater Newcastle
Liverpool Cancer Therapy Centre
Royal North Shore HospitalRecruiting
The Crown Princess Mary Cancer Centre WestmeadRecruiting
Peter MacCallum Cancer Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Multi-fraction SABR

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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

Patient treatment outcomes determined by assessing patient-reported outcomes

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.

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

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

Full Information

NCT ID

NCT02397317

First Posted

March 9, 2015

Last Updated

June 20, 2017

Sponsor

University of Sydney

Collaborators

Trans Tasman Radiation Oncology Group

1. Study Identification

Unique Protocol Identification Number

NCT02397317

Brief Title

Stereotactic Prostate Adaptive Radiotherapy Utilising Kilovoltage Intrafraction Monitoring

Acronym

SPARK

Official Title

Stereotactic Prostate Adaptive Radiotherapy Utilising Kilovoltage Intrafraction

Study Type

Interventional

2. Study Status

Record Verification Date

June 2017

Overall Recruitment Status

Unknown status

Study Start Date

February 2016 (undefined)

Primary Completion Date

December 2017 (Anticipated)

Study Completion Date

December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Sydney

Collaborators

Trans Tasman Radiation Oncology Group

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Multi-fraction SABR

Arm Type

Experimental

Arm Description

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

Intervention Type

Radiation

Intervention Name(s)

Multi-fraction SABR

Intervention Description

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

Primary Outcome Measure Information:

Title

Time Frame

up to 36 months

Secondary Outcome Measure Information:

Title

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

Time Frame

up to a maximum of 36 months.

Title

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

Title

Patient treatment outcomes determined by assessing patient-reported outcomes

Time Frame

12 and 24 months after treatment

Title

Time Frame

up to 36 months

Title

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

Time Frame

up to 36 months

Title

Time Frame

up to 36 months

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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) Exclusion Criteria: 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Paul Keall

Phone

+61 2 9351 3590

paul.keall@sydney.edu.au

First Name & Middle Initial & Last Name or Official Title & Degree

Angie Chung

Phone

+61 2 4014 3912

spark@trog.com.au

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Paul Keall

Organizational Affiliation

University of Sydney

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Jarad Martin

Organizational Affiliation

Calvary Mater Newcastle

Official's Role

Study Chair

Facility Information:

Facility Name

Calvary Mater Newcastle

City

Newcastle

State/Province

New South Wales

ZIP/Postal Code

2298

Country

Australia

Individual Site Status

Completed

Facility Name

Liverpool Cancer Therapy Centre

City

Sydney

State/Province

New South Wales

ZIP/Postal Code

1871

Country

Australia

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mark Sidhom

Phone

+61 2 8738 9806

mark.sidhom@sswahs.nsw.gov.au

Facility Name

Royal North Shore Hospital

City

Sydney

State/Province

New South Wales

ZIP/Postal Code

2065

Country

Australia

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Andrew Kneebone

Phone

+61 2 9463 1300

andrew.kneebone@health.nsw.gov.au

Facility Name

The Crown Princess Mary Cancer Centre Westmead

City

Sydney

State/Province

New South Wales

ZIP/Postal Code

2145

Country

Australia

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Amy Hayden

Phone

+61 2 9845 5200

amy.hayden@health.nsw.gov.au

Facility Name

Peter MacCallum Cancer Centre

City

Melbourne

State/Province

Victoria

ZIP/Postal Code

3000

Country

Australia

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Keen Hun Tai

Phone

(03) 8559 7720

KeenHun.Tai@petermac.org

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

32828839

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.

Results Reference

derived

PubMed Identifier

28270121

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.

Results Reference

derived

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Stereotactic Prostate Adaptive Radiotherapy Utilising Kilovoltage Intrafraction Monitoring

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