Clinical trial NCT06547398: Prostate Adaptive Radiation Therapy
Official title: Prostate Adaptive Radiation Therapy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Prostatic Neoplasms
Lead sponsor: Royal North Shore Hospital
Sponsor class: OTHER
Collaborators: name: Northern Sydney and Central Coast Area Health Service
First posted: 2024-08-09
Enrollment: 130
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomised to Adaptive radiotherapy or standard radiotherapy, 2:1 randomisation.
Primary purpose: TREATMENT

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.

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-

Primary outcomes:
measure: Safety of Adaptive Radiation Therapy via Radiation Therapists-led* treatment delivery (CTV coverage)
timeFrame: 12 months
measure: Safety of Adaptive Radiation Therapy via Radiation Therapists-led* treatment delivery (OAR DVH constraints)
timeFrame: 12 months
measure: Feasibility of ART via RT-led* treatment delivery
timeFrame: 12 months
measure: Acute patient reported toxicity
timeFrame: Within 90 days of patients completing treatment
Secondary outcomes:
measure: Acute clinician reported toxicity
timeFrame: Within 90 days of patients completing treatment
measure: Late clinician reported toxicity
timeFrame: 5 years
measure: Late patient reported toxicity
timeFrame: 5 years
measure: Biochemical progression Free Survival
timeFrame: 3 and 5 years
measure: Time differences between treatment arms
timeFrame: 1 and 5 years
measure: Radiation dosimetric differences between treatment arms
timeFrame: 1 and 5 years
measure: Patient reported attitudes and perceptions
timeFrame: 1 and 5 years
Other outcomes:
Locations:
city: St Leonards
country: Australia
facility: Northern Sydney Cancer Centre, Royal North Shore Hospital
state: New South Wales
Study officials:
affiliation: Northern Sydney Local Health District
name: Andrew Prof Kneebone, MBBS
role: PRINCIPAL_INVESTIGATOR
References: