Prostate Adaptive Radiation Therapy

Not Applicable

Not yet recruiting

• Conditions: Prostatic Neoplasms
• Interventions: Radiation: Adaptive radiotherapy +/- Margin Reduction; Radiation: Image guided radiotherapy

• Registration Number: NCT06547398
• Lead Sponsor: Royal North Shore Hospital

Brief 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.

Study Timeline

• Study First Submitted: 2024-07-25
• Study First Submitted QC: 2024-08-07
• Study First Posted: 2024-08-09
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-01
• Last Update Posted: 2024-10-03
• Study Start: 2024-10-31
• Primary Completion: 2029-10-31
• Study Completion: 2031-10-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 130

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-

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Adaptive radiotherapy +/- margin reduction	Adaptive radiotherapy +/- Margin Reduction	Phase 1 and 2: Treating Radiation Therapists (RTs) on the treatment machine will review the treatment target and organs at risk contours that are automatically generated on the plan of the day. They will modify these safely, as required, and then also approve the computer generated re-plan of the day, within the bounds of departmental protocols and decision guides (RT led). Phase 2 only: Margin reduction facilitated by adaptive radiotherapy.
Standard radiotherapy	Image guided radiotherapy	Patients will receive standard image guided radiotherapy

Primary Outcome Measures

Name	Time	Method
Safety of Adaptive Radiation Therapy via Radiation Therapists-led* treatment delivery (CTV coverage)	12 months	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).
Safety of Adaptive Radiation Therapy via Radiation Therapists-led* treatment delivery (OAR DVH constraints)	12 months	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.
Feasibility of ART via RT-led* treatment delivery	12 months	At least 90% of patients must have 90% of planned adaptive treatments successfully delivered in phase 1 of the study.
Acute patient reported toxicity	Within 90 days of patients completing treatment	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.

Secondary Outcome Measures

Name	Time	Method
Late patient reported toxicity	5 years	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.
Time differences between treatment arms	1 and 5 years	The study will assess the average absolute treatment time difference per fraction for adaptive radiation therapy compared to prostate IGRT.
Acute clinician reported toxicity	Within 90 days of patients completing treatment	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
Late clinician reported toxicity	5 years	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
Biochemical progression Free Survival	3 and 5 years	The rate of biochemical failure as defined as Nadir+2.0, commencement of ADT for relapse or evidence of disease recurrence on imaging
Radiation dosimetric differences between treatment arms	1 and 5 years	The study will evaluate the radiation dosimetric differences between treatment using ART and treatment using standard prostate IGRT
Patient reported attitudes and perceptions	1 and 5 years	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.

Trial Locations

Locations (1)

Northern Sydney Cancer Centre, Royal North Shore Hospital; 🇦🇺 St Leonards, New South Wales, Australia