Prostate Adaptive Radiation Therapy

NCT06547398 | Recruiting DMC

• 1 other identifier: Prostate ART
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostatic Neoplasms

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (7)

• Acute clinician reported toxicity

  Within 90 days of patients completing treatment

• Late clinician reported toxicity

  5 years

• Late patient reported toxicity

  5 years

• Biochemical progression Free Survival

  3 and 5 years

• Time differences between treatment arms

  1 and 5 years

Study Arms (2)

Adaptive radiotherapy +/- margin reduction

ACTIVE COMPARATOR

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.

Radiation: Adaptive radiotherapy +/- Margin Reduction

Standard radiotherapy

ACTIVE COMPARATOR

Patients will receive standard image guided radiotherapy

Radiation: Image guided radiotherapy

Interventions

Adaptive radiotherapy +/- Margin Reduction 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.

Also known as: ART

Adaptive radiotherapy +/- margin reduction

Image guided radiotherapy RADIATION

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

Also known as: IGRT

Standard radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Male over 18 years old
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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

You may not qualify if:

• Hip prosthesis
• Patient separation from prostate centre to skin edge \> 24cm, measured on diagnostic scan-

Sponsors & Collaborators

• Royal North Shore Hospital: lead
• Northern Sydney and Central Coast Area Health Service: collaborator

Study Sites (1)

Northern Sydney Cancer Centre, Royal North Shore Hospital

St Leonards, New South Wales, 2065, Australia

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Radiotherapy, Image-Guided

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics

Study Officials

• Andrew Prof Kneebone, MBBS

  Northern Sydney Local Health District

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nada Cheikh-Ali

CONTACT

+61294631345; nada.cheikhali@health.nsw.gov.au

Heidi Tsang

CONTACT

+61294631340; heidi.tsang@health.nsw.gov.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be randomised to Adaptive radiotherapy or standard radiotherapy, 2:1 randomisation.

Study Record Dates

• First Submitted: July 25, 2024
• First Posted: August 9, 2024
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 31, 2029
• Study Completion (Estimated): October 31, 2031
• Last Updated: February 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)