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Trial registered on ANZCTR


Registration number
ACTRN12621000227897
Ethics application status
Approved
Date submitted
15/12/2020
Date registered
4/03/2021
Date last updated
11/03/2022
Date data sharing statement initially provided
4/03/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
A study assessing the feasibility, toxicity and efficacy of Magnetic Resonance Imaging guided stereotactic radiotherapy to locally recurrent prostate tumours after prior radiotherapy
Scientific title
Feasibility of Magnetic Resonance Imaging guided stereotactic reirradiation in patients who have previously received radiation for prostate cancer and have biochemical and local recurrence of cancer within the prostate
Secondary ID [1] 302921 0
none
Universal Trial Number (UTN)
Trial acronym
PRIUS-MR (Prostate Re-Irradiation Using SABR and MRI guidance) pilot
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate cancer 320087 0
Condition category
Condition code
Cancer 318017 318017 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Repeat irradiation (re-irradiation) to recurrent tumour within the prostate gland, after prior radiotherapy or brachytherapy.

Treatment will be delivered on the Elekta Unity MRI-guided linear accelerator (MR-linac) using a dose of 34Gy in 5 fractions for those previously treated with external beam radiotherapy, or with brachytherapy if the recurrence is confined to the seminal vesicles. Patients with local recurrence within the prostate after brachytherapy will be treated to a dose of 30Gy in 5 fractions.

Treatment will be delivered 2 or 3 times a week, and not on consecutive days. Overall treatment is anticipated to be completed within 2 weeks.

Patients may be eligible for treatment if more than 2 years have elapsed between initial radiotherapy or brachytherapy and the detection of biochemical failure, provided other eligibility criteria are met.

Treatment will be administered by radiation therapists, with daily plan adaptation under the supervision of the treating radiation oncologist, who will also be defining the target volume and surrounding normal organs at risk.

Adherence to treatment will be monitored by review of daily radiotherapy treatment plans and the medical records at the completion of treatment.
Intervention code [1] 319310 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 326013 0
Feasibility, as determined by the ability to complete treatment in under 90 minutes in 90% of treatments. Time taken to deliver individual treatments will be recorded with time stamps at multiple steps of the treatment pathway and logged on a database.
Timepoint [1] 326013 0
Feasibility will be assessed immediately after each treatment (and defined as successful if treatment was completed in under 90 minutes) until all patients have completed their treatment.
Secondary outcome [1] 389857 0
Toxicity will be assessed using Common Toxicity Criteria for Adverse Events (CTCAE) v5.0, the International Prostate Symptom Score (IPSS), and the International Index of Erectile Dysfunction (IIEF-5). These will be completed by the patient and clinician at multiple time points at baseline and during the follow up period. The toxicity assessment will be performed as a composite of the results of these tools.
Timepoint [1] 389857 0
Toxicity data will be collected at baseline, 4-6 weeks after treatment, every 3 months until the end of 12 months, every 6 months until 24 months and then annually. Toxicity will be reported at the end of 36 months.
Secondary outcome [2] 389858 0
Time to second biochemical failure, defined as a further rise of 2 ug/L above the PSA taken at commencement of reirradiation.
Timepoint [2] 389858 0
PSA will be collected at baseline, 4-6 weeks after treatment, every 3 months until the end of 12 months, every 6 months until 24 months and then annually.
Secondary outcome [3] 392300 0
Quality of Life will be a composite assessment, using the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 and QLQ-PR25, and Euroqol EQ-5D-5L questionnaires.
Timepoint [3] 392300 0
Quality of life data will be collected at baseline, 4-6 weeks after treatment, 6 and 12 months after treatment and then annually.

Eligibility
Key inclusion criteria
- Histologically confirmed recurrent prostate cancer, previously treated with external beam radiotherapy or low dose rate (LDR) brachytherapy
- At least 2 years between completion of primary radiotherapy course and detection of biochemical failure as per by Phoenix definition (PSA nadir + 2)
- Prostate Specific Antigen (PSA) doubling time > 6 months
- Life expectancy > 5 years
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Magnetic Resonance Imaging (MRI) and/or Prostate Specific Membrane Antigen Positron Emission Tomography (PSMA PET) demonstrating locally recurrent disease involving a single focus within the prostate or seminal vesicles (i.e. multifocal recurrence not permitted)
- Patients with metastatic disease may be enrolled provided they have oligometastases to no more than 5 sites (lymph node or bone), and all sites are amenable to surgery or Stereotactic Ablative Body Radiotherapy (SABR)
- Concomitant use of androgen deprivation therapy (ADT) is permissible, but only patients who are not on ADT at the time of enrolment will be analysed for time to second biochemical failure
- Able to provide written informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
- Prior prostatectomy
- Inability to undergo MRI (per department MRI safety protocol)
- Any Grade 2 or higher late genitourinary toxicity believed to be directly related to prior radiotherapy (except in sexual function domain)
- Any Grade 2 or higher late gastrointestinal toxicity believed to be directly related to prior radiotherapy
- PSA greater than 20ug/L at time of relapse

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
5/04/2021
Actual
14/07/2021
Date of last participant enrolment
Anticipated
30/12/2022
Actual
Date of last data collection
Anticipated
30/12/2024
Actual
Sample size
Target
25
Accrual to date
4
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 18819 0
The Townsville Hospital - Douglas
Recruitment postcode(s) [1] 32268 0
4810 - Townsville
Recruitment postcode(s) [2] 33270 0
4814 - Douglas

Funding & Sponsors
Funding source category [1] 307341 0
Charities/Societies/Foundations
Name [1] 307341 0
Australia and New Zealand Urogenital and Prostate trials group (ANZUP), Below the Belt fund
Country [1] 307341 0
Australia
Funding source category [2] 307431 0
Hospital
Name [2] 307431 0
Tropical Australian Academic and Health Centre (TAAHC)
Country [2] 307431 0
Australia
Primary sponsor type
Individual
Name
Christopher Rumley
Address
Townsville Cancer Centre
IMB 56 Townsville University Hospital
PO Box 670
Townsville
QLD 4810
Country
Australia
Secondary sponsor category [1] 308102 0
None
Name [1] 308102 0
Address [1] 308102 0
Country [1] 308102 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307428 0
Human Research Ethics Committee, Townsville Hospital and Health Service
Ethics committee address [1] 307428 0
Townsville University Hospital
PO Box 670
Townsville
QLD 4810
Ethics committee country [1] 307428 0
Australia
Date submitted for ethics approval [1] 307428 0
27/10/2020
Approval date [1] 307428 0
08/12/2020
Ethics approval number [1] 307428 0
HREC/QTHS/66869

Summary
Brief summary
This study is investigating the feasibility of delivering salvage re-irradiation to the prostate gland in men who have previously received radiation.

Who is it for?
You may be eligible for this trial if you are a male aged 18 years or over, have previously treated been treated for prostate cancer with external beam radiotherapy or brachytherapy and have a local recurrence within the prostate, with no more than 5 distant metastases.

Study details
Participants will receive radiation to the prostate gland using Magnetic Guided adaptive radiotherapy on the MRI linear accelerator. The intervention is intended to be delivered as 5 radiotherapy sessions over 2 weeks. Participants will be asked to provide 9 blood samples throughout the study to assess the response to treatment. Data on toxicity and prostate specific antigen (PSA) response to treatment will be collected.

Information from this study will be used to determine whether a MRI-guided approach to radiotherapy is a feasible clinical approach for the treatment of recurrent prostate cancer.
Trial website
Trial related presentations / publications
Public notes
This study aims primarily to investigate the feasibility of delivering salvage re-irradiation to the prostate gland in men who have previously received radiation (external beam or brachytherapy) to the prostate gland using Magnetic Guided adaptive radiotherapy on the MRI linear accelerator. Treatment will be considered feasible if a treatment can be delivered successfully in under 90 minutes, in 90% of treatments. To our knowledge, it will be the first study of its kind looking at re-irradiation using MR-guided radiotherapy. We will also collect data on toxicity to compare with contemporary studies delivering this treatment without MRI guidance, and collect data on PSA response to determine if treatment effectively delays PSA progression.

Contacts
Principal investigator
Name 107210 0
Dr Christopher Rumley
Address 107210 0
Townsville Cancer Centre
Townsville University Hospital, IMB 56
PO Box 670
Townsville QLD 4810
Country 107210 0
Australia
Phone 107210 0
+61 744331622
Fax 107210 0
+61744331621
Email 107210 0
[email protected]
Contact person for public queries
Name 107211 0
Christopher Rumley
Address 107211 0
Townsville Cancer Centre
Townsville University Hospital, IMB 56
PO Box 670
Townsville QLD 4810
Country 107211 0
Australia
Phone 107211 0
+61 744331622
Fax 107211 0
+61744331621
Email 107211 0
[email protected]
Contact person for scientific queries
Name 107212 0
Christopher Rumley
Address 107212 0
Townsville Cancer Centre
Townsville University Hospital, IMB 56
PO Box 670
Townsville QLD 4810
Country 107212 0
Australia
Phone 107212 0
+61 744331622
Fax 107212 0
+61744331621
Email 107212 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
10040Ethical approval    381038-(Uploaded-15-12-2020-11-45-41)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.