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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06547398




Registration number
NCT06547398
Ethics application status
Date submitted
25/07/2024
Date registered
9/08/2024

Titles & IDs
Public title
Prostate Adaptive Radiation Therapy
Scientific title
Prostate Adaptive Radiation Therapy
Secondary ID [1] 0 0
Prostate ART
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostatic Neoplasms 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Adaptive radiotherapy +/- Margin Reduction
Treatment: Other - Image guided radiotherapy

Active comparator: 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.

Active comparator: Standard radiotherapy - Patients will receive standard image guided radiotherapy


Treatment: Other: 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.

Treatment: Other: Image guided radiotherapy
Standard radiation treatment used in the department of radiation oncology for prostate cancer
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety of Adaptive Radiation Therapy via Radiation Therapists-led* treatment delivery (CTV coverage)
Assessment method [1] 0 0
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).
Timepoint [1] 0 0
12 months
Primary outcome [2] 0 0
Safety of Adaptive Radiation Therapy via Radiation Therapists-led* treatment delivery (OAR DVH constraints)
Assessment method [2] 0 0
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.
Timepoint [2] 0 0
12 months
Primary outcome [3] 0 0
Feasibility of ART via RT-led* treatment delivery
Assessment method [3] 0 0
At least 90% of patients must have 90% of planned adaptive treatments successfully delivered in phase 1 of the study.
Timepoint [3] 0 0
12 months
Primary outcome [4] 0 0
Acute patient reported toxicity
Assessment method [4] 0 0
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.
Timepoint [4] 0 0
Within 90 days of patients completing treatment
Secondary outcome [1] 0 0
Acute clinician reported toxicity
Assessment method [1] 0 0
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
Timepoint [1] 0 0
Within 90 days of patients completing treatment
Secondary outcome [2] 0 0
Late clinician reported toxicity
Assessment method [2] 0 0
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
Timepoint [2] 0 0
5 years
Secondary outcome [3] 0 0
Late patient reported toxicity
Assessment method [3] 0 0
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.
Timepoint [3] 0 0
5 years
Secondary outcome [4] 0 0
Biochemical progression Free Survival
Assessment method [4] 0 0
The rate of biochemical failure as defined as Nadir+2.0, commencement of ADT for relapse or evidence of disease recurrence on imaging
Timepoint [4] 0 0
3 and 5 years
Secondary outcome [5] 0 0
Time differences between treatment arms
Assessment method [5] 0 0
The study will assess the average absolute treatment time difference per fraction for adaptive radiation therapy compared to prostate IGRT.
Timepoint [5] 0 0
1 and 5 years
Secondary outcome [6] 0 0
Radiation dosimetric differences between treatment arms
Assessment method [6] 0 0
The study will evaluate the radiation dosimetric differences between treatment using ART and treatment using standard prostate IGRT
Timepoint [6] 0 0
1 and 5 years
Secondary outcome [7] 0 0
Patient reported attitudes and perceptions
Assessment method [7] 0 0
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.
Timepoint [7] 0 0
1 and 5 years

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
1. Hip prosthesis
2. Patient separation from prostate centre to skin edge > 24cm, measured on diagnostic scan-

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
31/10/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/10/2031
Actual
Sample size
Target
130
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Northern Sydney Cancer Centre, Royal North Shore Hospital - St Leonards
Recruitment postcode(s) [1] 0 0
2065 - St Leonards

Funding & Sponsors
Primary sponsor type
Other
Name
Royal North Shore Hospital
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Northern Sydney and Central Coast Area Health Service
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Andrew Prof Kneebone, MBBS
Address 0 0
Northern Sydney Local Health District
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Carol Kwong
Address 0 0
Country 0 0
Phone 0 0
+61294631339
Email 0 0
carolyn.kwong@health.nsw.gov.au
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06547398