Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 3 for:    sidhom | Australia
Previous Study | Return to List | Next Study

Stereotactic Prostate Adaptive Radiotherapy Utilising Kilovoltage Intrafraction Monitoring (SPARK)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02397317
Recruitment Status : Recruiting
First Posted : March 24, 2015
Last Update Posted : June 22, 2017
Sponsor:
Collaborator:
Trans-Tasman Radiation Oncology Group (TROG)
Information provided by (Responsible Party):
University of Sydney

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Radiation: Multi-fraction SABR Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Stereotactic Prostate Adaptive Radiotherapy Utilising Kilovoltage Intrafraction
Study Start Date : February 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02397317


Contacts
Layout table for location contacts
Contact: Paul Keall +61 2 9351 3590 paul.keall@sydney.edu.au
Contact: Angie Chung +61 2 4014 3912 spark@trog.com.au

Locations
Layout table for location information
Australia, New South Wales
Calvary Mater Newcastle Completed
Newcastle, New South Wales, Australia, 2298
Liverpool Cancer Therapy Centre Not yet recruiting
Sydney, New South Wales, Australia, 1871
Contact: Mark Sidhom    +61 2 8738 9806    mark.sidhom@sswahs.nsw.gov.au   
Royal North Shore Hospital Recruiting
Sydney, New South Wales, Australia, 2065
Contact: Andrew Kneebone    +61 2 9463 1300    andrew.kneebone@health.nsw.gov.au   
The Crown Princess Mary Cancer Centre Westmead Recruiting
Sydney, New South Wales, Australia, 2145
Contact: Amy Hayden    +61 2 9845 5200    amy.hayden@health.nsw.gov.au   
Australia, Victoria
Peter MacCallum Cancer Centre Not yet recruiting
Melbourne, Victoria, Australia, 3000
Contact: Keen Hun Tai    (03) 8559 7720    KeenHun.Tai@petermac.org   
Sponsors and Collaborators
University of Sydney
Trans-Tasman Radiation Oncology Group (TROG)
Investigators
Layout table for investigator information
Study Chair: Paul Keall University of Sydney
Study Chair: Jarad Martin Calvary Mater Newcastle
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: University of Sydney
ClinicalTrials.gov Identifier: NCT02397317    
Other Study ID Numbers: TROG 15.01 SPARK
TROG 15.01 ( Other Identifier: Trans Tasman Radiation Oncology Group )
First Posted: March 24, 2015    Key Record Dates
Last Update Posted: June 22, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases