TROG 15.01 (SPARK) Efficacy of Kilovoltage Intrafraction Monitoring (KIM) in men with prostate cancer undergoing stereotactic prostate radiotherapy

Phase 2

Completed

• Conditions: Prostate Cancer; Cancer - Prostate

• Registration Number: ACTRN12615000335594
• Lead Sponsor: The University of Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-04-14
• Last Update Posted: 28 June 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 49

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)
*if on anticoagulants, must be approved for procedure

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
A dose accumulation method will be used to determine the efficacy of KIM, where the isodose distributions and dose volume histograms for each session will be calculated with Kilovoltage Intrafraction Monitoring (KIM) corrections as treated, and estimated without KIM corrections[After all patients have completed their final SABR treatment session]