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Trial Title:
Prostate Adaptive Radiation Therapy
NCT ID:
NCT06547398
Condition:
Prostatic Neoplasms
Conditions: Official terms:
Prostatic Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Patients will be randomised to Adaptive radiotherapy or standard radiotherapy, 2:1
randomisation.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Adaptive radiotherapy +/- Margin Reduction
Description:
Radiotherapy using adaptive technology to recontour and replan daily as required.
Reductions in the PTV margin will also be introduced in the second phase of this study.
Arm group label:
Adaptive radiotherapy +/- margin reduction
Other name:
ART
Intervention type:
Radiation
Intervention name:
Image guided radiotherapy
Description:
Standard radiation treatment used in the department of radiation oncology for prostate
cancer
Arm group label:
Standard radiotherapy
Other name:
IGRT
Summary:
Prostate ART is a two phase study looking at using adaptive radiotherapy to help reduce
toxicity for prostate cancer patients.
Adaptive radiotherapy is a new technology that provides the ability to account for daily
changes in anatomy. Adaptive radiotherapy also provides a foundation for which
radiotherapy margins might be safely reduced.
Phase 1 of this study is looking to see if a radiation therapist centred adaptive
workflow can be implemented. If phase 1 of this study is safe and feasible, the study
will proceed to phase 2.
Part 2 of the study looks at using adaptive technology to reduce radiation treatment
margins. The primary aim of this study is to see whether margin reduced treatment using
adaptive radiotherapy can reduce side effects for prostate cancer patients.
Detailed description:
Despite major technological advancements in the delivery of pelvic radiation therapy
including the use of dynamic therapy, image guidance, integrated boosting and
stereotactic techniques, toxicity from pelvic radiation remains a significant issue
impacting on patient's quality of life and preventing the delivery of higher (and more
curative) doses of radiation. Although evidence showed that adaptive radiotherapy
demonstrating promising reduction of acute toxicity, the uptake of adaptive radiotherapy
remains poor as adaptive radiation therapy is very labour intensive, time consuming and
usually requires a radiation oncologist (RO) and Medical Physicist in attendance to
review/modify target contours. These practices of daily multi-disciplinary team (MDT) in
person attendance is not sustainable in the long term.
Since 2021, Royal North Shore Hospital has been treating patients with cancer in the
pelvic with Adaptive Radiation Therapy (ART) and Radiation Therapists (RT) at the site
have undergone a rigorous University based Advanced Practitioner training programme.
This study aims to evaluate RT-led ART in a randomised trial to assess the safety and
feasibility of ART in a two stage phase 3 randomised controlled trial. If this study can
prove safety and feasibility in the first phase, it will proceed to the second phase of
the study which will look at using adaptive radiotherapy to safely reduce CTV and PTV
margins.
The primary aim of the study will be to measure the difference in combined acute patient
reported gastrointestinal (GI) and genitourinary (GU) toxicity between ART with margin
reduction versus standard radiotherapy. Secondary aims will be to look at differences in
biochemical failure, the time efficiency of ART, the radiation dosimetric differences
between the treatment arms and patients' perception of ART.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1.
- Age > 18
2. Biopsy proven prostate malignancy
3. Definitive treatment is radiotherapy to the prostate alone
4. ECOG performance status 0-2
5. Ability to understand and the willingness to sign an informed consent
Exclusion Criteria:
1. Hip prosthesis
2. Patient separation from prostate centre to skin edge > 24cm, measured on diagnostic
scan-
Gender:
Male
Gender based:
Yes
Gender description:
Male over 18 years old
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Northern Sydney Cancer Centre, Royal North Shore Hospital
Address:
City:
St Leonards
Zip:
2065
Country:
Australia
Contact:
Last name:
Andrew Kneebone, MBBS
Phone:
+61294631300
Email:
Andrew.Kneebone@health.nsw.gov.au
Contact backup:
Last name:
Carol Kwong
Phone:
+61294631339
Email:
Carolyn.kwong@health.nsw.gov.au
Investigator:
Last name:
Thomas Eade, MBBS
Email:
Sub-Investigator
Investigator:
Last name:
George Hruby, MBBS
Email:
Sub-Investigator
Investigator:
Last name:
Sarah Bergamin, MBBS
Email:
Sub-Investigator
Investigator:
Last name:
Joseph Chan, MBBS
Email:
Sub-Investigator
Start date:
October 31, 2024
Completion date:
October 31, 2031
Lead sponsor:
Agency:
Royal North Shore Hospital
Agency class:
Other
Collaborator:
Agency:
Northern Sydney and Central Coast Area Health Service
Agency class:
Other
Source:
Royal North Shore Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06547398
