Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000830392
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
18/06/2026
Date registered
Help: Date registered
10/07/2026
Date last updated
Help: Date last updated
20/07/2026
Date data sharing statement initially provided
Help: Data sharing statement date
10/07/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
sTereOtactic Radiotherapy aNd Androgen suppression for De novo Oligometastatic prostate cancer
Scientific title
Assessing toxicity and quality of life in patients treated with stereotactic ablative radiation therapy to all metastatic sites for de novo oligometastatic prostate cancer
Additional trial identifiers [1] 317629 0
Nil
Universal Trial Number (UTN)
Trial acronym
TORNADO
Related trial records

Health condition
Health condition(s) studied:
De novo metastatic prostate cancer 342399 0
Condition category
Condition code
Cancer 338531 338531 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Patients will receive stereotactic ablative body radiotherapy (SABR) to the prostate and metastatic sites delivered in two fractions, one fraction per week. Each SABR session will take approximately 30 minutes, This study will aim to deliver 2-fraction SABR 24 Gy in 2 fractions to the prostate and metastatic sites.

SABR will be prescribed by treating radiation oncologist. Adherence to the intervention will be assessed by review of medical records..
All participants will be on standard care systemic therapy which is an eligibility criteria for the trial, which typically includes androgen deprivation therapy and androgen receptor pathway inhibitor. The systemic therapy agent, dose, frequency and administration is dependent on that prescribed by the clinician. SABR treatment needs to be started within 90 days of commencement of systemic therapy
Intervention code [1] 334448 0
Treatment: Other
Description of the comparator or control
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 345809 0
Acute (<=3 months) grade 2+ adverse events This will be assessed as a composite outcome.
Timepoint [1] 345809 0
During treatment (week 2), and 4 weeks and 3 months post completion of SABR treatment
Secondary outcome [1] 463392 0
Late (>=6 months to 5 years) grade 2+ adverse events This will be assessed as a composite outcome.
Timepoint [1] 463392 0
At 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 months post- completion SABR treatment.
Secondary outcome [2] 463393 0
Acute (<=3 months) effects on bowel quality of life
Timepoint [2] 463393 0
4 weeks and 3 months post completion of SABR treatment (cumulative)
Secondary outcome [3] 463394 0
Acute (<=3 months) effects on sexual quality of life
Timepoint [3] 463394 0
4 weeks and 3 months post completion of SABR treatment (cumulative)
Secondary outcome [4] 463395 0
Acute (<=3 months) effects on urinary quality of life
Timepoint [4] 463395 0
4 weeks and 3 months post completion of SABR treatment (cumulative)
Secondary outcome [5] 463396 0
Late (>=6 months to 5 years) urinary quality of life
Timepoint [5] 463396 0
At 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 months post- completion SABR treatment (cumulative)
Secondary outcome [6] 463397 0
Late (>=6 months to 5 years) bowel quality of life
Timepoint [6] 463397 0
At 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 months post- completion SABR treatment (cumulative)
Secondary outcome [7] 463400 0
Late (>=6 months to 5 years) sexual quality of life
Timepoint [7] 463400 0
At 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 months post- completion SABR treatment (cumulative)
Secondary outcome [8] 463401 0
3-month PSMA PET response of the SABR treated primary and metastatic sites. This will be assessed as a composite outcome.
Timepoint [8] 463401 0
At 3 months post SABR
Secondary outcome [9] 463402 0
Proportion of patients with 12 month PSA response (i.e. PSA< 0.2ng/mL at the end of trial-specified treatment)
Timepoint [9] 463402 0
At 12 months post SABR-treatment
Secondary outcome [10] 463403 0
Progression free survival (PFS)
Timepoint [10] 463403 0
Determined during follow-up at 3, 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 months post- completion SABR treatment
Secondary outcome [11] 464419 0
Acute (<=3 months) effects on urinary quality of life
Timepoint [11] 464419 0
4 weeks and 3 months post completion of SABR treatment (cumulative)
Secondary outcome [12] 464420 0
Late (>=6 months to 5 years) urinary quality of life
Timepoint [12] 464420 0
At 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 months post- completion SABR treatment (cumulative)

Eligibility
Key inclusion criteria
- Histologically confirmed prostate adenocarcinoma
- Evidence of oligo-metastases (>10 nodal or bone metastases) on prostate specific membrane antigen positron emission tomography (PSMA PET) (M1a/ M1b), with no evidence of visceral metastases (M1c)
- ECOG 0-2
- Life expectancy >12 months
- Capacity to consent to treatment and comply with follow-up schedule and completion of QOL questionnaires
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Healthy volunteers
No
Key exclusion criteria
- Serum PSA at diagnosis >100 ng/mL
- Rare histological variant e.g. small cell carcinoma of prostate
- Prostate volume >100cc (on diagnostic MRI)
- cT4 disease (i.e. tumour fixed or invades adjacent structures other than seminal vesicles, such as external sphincter, rectum, bladder, levator muscle and/ or pelvic wall), or locally advanced primary disease deemed not amenable to SABR by the treating clinicians
- Presence of visceral metastases (M1c)
- Metastatic sites deemed not amenable to SABR by treating clinicians (e.g. unable to meet organs-at-risk dose constraints)
- Contraindications for magnetic resonance imaging (MRI)
- Prior pelvic radiation therapy
- Severe obstructive lower urinary tract symptoms (International Prostate Symptom Score >20)
- Bleeding diathesis or use of anti-coagulation that is unsafe to discontinue for fiducial marker
- Comorbidities which predispose to significant radiation therapy adverse events (e.g., inflammatory bowel disease)
- Pelvic metalwork (e.g. hip replacement) that may cause artefact on diffusion-weighted magnetic resonance imaging.
- Contraindication for androgen deprivation therapy and androgen receptor pathway inhibitors (ARPI)

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/07/2026
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
19
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 322171 0
Hospital
Name [1] 322171 0
Alfred Hospital
Country [1] 322171 0
Australia
Primary sponsor type
Hospital
Name
Alfred Hospital
Address
Country
Australia
Secondary sponsor category [1] 325071 0
None
Name [1] 325071 0
Address [1] 325071 0
Country [1] 325071 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 320703 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 320703 0
Ethics committee country [1] 320703 0
Australia
Date submitted for ethics approval [1] 320703 0
07/05/2026
Approval date [1] 320703 0
08/07/2026
Ethics approval number [1] 320703 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 151338 0
Prof Wee Loon Ong
Address 151338 0
Alfred Hospital, 55 Commercial Road, Melbourne 3002, VIC
Country 151338 0
Australia
Phone 151338 0
+61 3 90762360
Fax 151338 0
Email 151338 0
[email protected]
Contact person for public queries
Name 151339 0
Wee Loon Ong
Address 151339 0
Alfred Hospital, 55 Commercial Road, Melbourne 3002, VIC
Country 151339 0
Australia
Phone 151339 0
+61 3 90762360
Fax 151339 0
Email 151339 0
[email protected]
Contact person for scientific queries
Name 151340 0
Wee Loon Ong
Address 151340 0
Alfred Hospital, 55 Commercial Road, Melbourne 3002, VIC
Country 151340 0
Australia
Phone 151340 0
+61 3 90762360
Fax 151340 0
Email 151340 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


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.