Prostate Adaptive Radiation Therapy
NCT Number: NCT06547398
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Prostatic Neoplasms
Interventions: RADIATION: Adaptive radiotherapy +/- Margin Reduction|RADIATION: Image guided radiotherapy
Sponsor: Royal North Shore Hospital
Collaborators: Northern Sydney and Central Coast Area Health Service
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 130
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-31
Completion Date: 2031-08-31
Locations: Northern Sydney Cancer Centre, Royal North Shore Hospital, St Leonards, New South Wales, 2065, Australia

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.

Primary Outcome Measures: Safety of Adaptive Radiation Therapy via Radiation Therapists-led* treatment delivery (CTV coverage), A comparison of Clinical Target Volume (CTV) dose coverage will be performed.

The CTV dose coverage must be equal or better in 90% of fractions for 90% of patients compared with the virtual image guided radiotherapy (IGRT) fraction. Dose coverage will be calculated as the percent of CTV receiving at least 95% of the prescribed dose (TD)., 12 months|Safety of Adaptive Radiation Therapy via Radiation Therapists-led* treatment delivery (OAR DVH constraints), A comparison of organ at risk (OAR) dose-volume histogram (DVH) constraints will be performed.

The OAR DVH dose constraints must be equal or better in 90% of fractions for 90% of patients compared with the virtual image guided radiotherapy (IGRT) fraction., 12 months|Feasibility of ART via RT-led* treatment delivery, At least 90% of patients must have 90% of planned adaptive treatments successfully delivered in phase 1 of the study., 12 months|Acute patient reported toxicity, The study will measure the difference in patient reported combined maximum GU and GI toxicity (Grade 2 or higher) as per PRO-CTCAE between the two treatment arms., Within 90 days of patients completing treatment
Secondary Outcome Measures: Acute clinician reported toxicity, The study will measure the difference in acute combined maximum GU and GI toxicity (Grade 2 or higher) grading between the two treatment arms as reported by clinicians using CTCAE v5.0, Within 90 days of patients completing treatment|Late clinician reported toxicity, The study will measure the difference in late GU and GI toxicity (Grade 2 or higher) between the two treatment arms as reported by clinicians using CTCAE v5.0, 5 years|Late patient reported toxicity, The study will measure the difference in patient reported late GU and GI toxicity (Grade 2 or higher) between the two treatment arms as per PRO-CTCAE., 5 years|Biochemical progression Free Survival, The rate of biochemical failure as defined as Nadir+2.0, commencement of ADT for relapse or evidence of disease recurrence on imaging, 3 and 5 years|Time differences between treatment arms, The study will assess the average absolute treatment time difference per fraction for adaptive radiation therapy compared to prostate IGRT., 1 and 5 years|Radiation dosimetric differences between treatment arms, The study will evaluate the radiation dosimetric differences between treatment using ART and treatment using standard prostate IGRT, 1 and 5 years|Patient reported attitudes and perceptions, The study will assess the patient experience with radiotherapy on a five item questionnaire that uses a five-point Likert-scale (ranging from strongly disagree to strongly agree). Differences in responses for each question between the arms will be reported., 1 and 5 years