Stereotactic Prostate Adaptive Radiotherapy Utilising Kilovoltage Intrafraction Monitoring

Prostate Cancer Clinical Trial

— SPARK  

Official title:

Stereotactic Prostate Adaptive Radiotherapy Utilising Kilovoltage Intrafraction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02397317
• Other study ID #: TROG 15.01 SPARK
• Secondary ID: TROG 15.01
• Status: Recruiting
• Phase: Phase 2
• First received: March 9, 2015
• Last updated: June 20, 2017
• Start date: February 2016
• Est. completion date: December 2020

Study information

• Verified date: June 2017
• Source: University of Sydney
• Contact: Paul Keall
• Phone: +61 2 9351 3590
• Email: paul.keall[@]sydney.edu.au
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: December 2020
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer

Intervention

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

Locations

Country	Name	City	State
Australia	Peter MacCallum Cancer Centre	Melbourne	Victoria
Australia	Calvary Mater Newcastle	Newcastle	New South Wales
Australia	Liverpool Cancer Therapy Centre	Sydney	New South Wales
Australia	Royal North Shore Hospital	Sydney	New South Wales
Australia	The Crown Princess Mary Cancer Centre Westmead	Sydney	New South Wales

Sponsors (2)

Lead Sponsor	Collaborator
University of Sydney	Trans-Tasman Radiation Oncology Group (TROG)

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Patient treatment outcomes determined by assessing Biochemical-clinical failure (BCF)		up to a maximum of 36 months.
Secondary	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
Secondary	Patient treatment outcomes determined by assessing patient-reported outcomes		12 and 24 months after treatment
Secondary	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
Secondary	Targeting accuracy through measuring the final geometric accuracy with and without the KIM gating procedure		up to 36 months
Secondary	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		up to 36 months