Prostate Adaptive Radiation Therapy

NCT ID: NCT06547398

Last Updated: 2024-10-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-31
• Study Completion Date: 2031-10-31

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.

Conditions

Prostatic Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Adaptive radiotherapy +/- Margin Reduction

Intervention Type: RADIATION

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.

Standard radiotherapy

Patients will receive standard image guided radiotherapy

Group Type: ACTIVE_COMPARATOR

Image guided radiotherapy

Intervention Type: RADIATION

Standard radiation treatment used in the department of radiation oncology for prostate cancer

Interventions

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.

Intervention Type: RADIATION

Image guided radiotherapy

Standard radiation treatment used in the department of radiation oncology for prostate cancer

Intervention Type: RADIATION

Other Intervention Names

ART; IGRT

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-

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Northern Sydney and Central Coast Area Health Service

OTHER

Sponsor Role: collaborator

Royal North Shore Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrew Prof Kneebone, MBBS

Role: PRINCIPAL_INVESTIGATOR

Northern Sydney Local Health District

Locations

Northern Sydney Cancer Centre, Royal North Shore Hospital

St Leonards, New South Wales, Australia

Countries

Australia

Central Contacts

Carol Kwong

Role: CONTACT

carolyn.kwong@health.nsw.gov.au

+61294631339

Heidi Tsang

Role: CONTACT

heidi.tsang@health.nsw.gov.au

+61294631340

Facility Contacts

Andrew Kneebone, MBBS

Role: primary

Andrew.Kneebone@health.nsw.gov.au

+61294631300

Carol Kwong

Role: backup

Carolyn.kwong@health.nsw.gov.au

+61294631339

Other Identifiers

Prostate ART

Identifier Type: -

Identifier Source: org_study_id