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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)
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)
Timepoint [2] 0 0
12 months
Primary outcome [3] 0 0
Feasibility of ART via RT-led* treatment delivery
Timepoint [3] 0 0
12 months
Primary outcome [4] 0 0
Acute patient reported toxicity
Timepoint [4] 0 0
Within 90 days of patients completing treatment
Secondary outcome [1] 0 0
Acute clinician reported toxicity
Timepoint [1] 0 0
Within 90 days of patients completing treatment
Secondary outcome [2] 0 0
Late clinician reported toxicity
Timepoint [2] 0 0
5 years
Secondary outcome [3] 0 0
Late patient reported toxicity
Timepoint [3] 0 0
5 years
Secondary outcome [4] 0 0
Biochemical progression Free Survival
Timepoint [4] 0 0
3 and 5 years
Secondary outcome [5] 0 0
Time differences between treatment arms
Timepoint [5] 0 0
1 and 5 years
Secondary outcome [6] 0 0
Radiation dosimetric differences between treatment arms
Timepoint [6] 0 0
1 and 5 years
Secondary outcome [7] 0 0
Patient reported attitudes and perceptions
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
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Northern Sydney and Central Coast Area Health Service
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
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
Fax 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
Fax 0 0
Email 0 0
carolyn.kwong@health.nsw.gov.au
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No IPD will be shared with other researchers. Only group data will be published.


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