Prostate Adaptive Radiation Therapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Adaptive radiotherapy +/- Margin Reduction, Image guided radiotherapy.
- Who it may be relevant to
- Registry conditions: Prostatic Neoplasms. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Australia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Radiation Adaptive radiotherapy +/- Margin Reduction
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. - Radiation Image guided radiotherapy
Standard radiation treatment used in the department of radiation oncology for prostate cancer
Primary outcome measures
- Safety of Adaptive Radiation Therapy via Radiation Therapists-led* treatment delivery (CTV coverage) [Time frame: 12 months]
- Safety of Adaptive Radiation Therapy via Radiation Therapists-led* treatment delivery (OAR DVH constraints) [Time frame: 12 months]
- Feasibility of ART via RT-led* treatment delivery [Time frame: 12 months]
- Acute patient reported toxicity [Time frame: Within 90 days of patients completing treatment]
Secondary outcome measures (7)
- Acute clinician reported toxicity [Time frame: Within 90 days of patients completing treatment]
- Late clinician reported toxicity [Time frame: 5 years]
- Late patient reported toxicity [Time frame: 5 years]
- Biochemical progression Free Survival [Time frame: 3 and 5 years]
- Time differences between treatment arms [Time frame: 1 and 5 years]
- Radiation dosimetric differences between treatment arms [Time frame: 1 and 5 years]
- Patient reported attitudes and perceptions [Time frame: 1 and 5 years]
Eligibility criteria
Inclusion criteria
- \- Age > 18
- Biopsy proven prostate malignancy
- Definitive treatment is radiotherapy to the prostate alone
- ECOG performance status 0-2
- Ability to understand and the willingness to sign an informed consent
Exclusion criteria
- Hip prosthesis
- Patient separation from prostate centre to skin edge > 24cm, measured on diagnostic scan-
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Australia · 1 center
- Northern Sydney Cancer Centre, Royal North Shore Hospital — St Leonards
Identifiers
NCT: NCT06547398 · Prostate ART