Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000487415
Ethics application status
Approved
Date submitted
28/04/2025
Date registered
20/05/2025
Date last updated
20/05/2025
Date data sharing statement initially provided
20/05/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of Toxicity Reduction with Urethra Sparing radiation Therapy for prostate cancer (TRUST)
Scientific title
Efficacy of toxicity reduction with urethra sparing stereotactic ablative body radiation therapy for prostate cancer, assessing toxicities and quality of life in patients with intermediate risk prostate cancer.
Secondary ID [1] 314302 0
None
Universal Trial Number (UTN)
Trial acronym
TRUST
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Biopsy proven intermediate risk prostate cancer 337247 0
Condition category
Condition code
Cancer 333654 333654 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will receive stereotactic ablative radiotherapy (SABR) to the prostate, delivered in five fractions, two to the three fractions per week. This study will aim to deliver 5-fraction prostate SABR 36.25 Gy in 5 fractions to the prostate, with simultaneous dose reduction to the urethra to 32.5 Gy in 5 fractions.

SABR will be prescribed by the treating radiation oncologist. Adherence to the intervention will be assessed by review of medical records.
Intervention code [1] 330916 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 341238 0
Acute (<3 months) effects on urinary quality of life. This will be assessed as a composite outcome.
Timepoint [1] 341238 0
4 weeks and 3 months post completion of SABR treatment (cumulative)
Secondary outcome [1] 446876 0
Late (>6 months to 5 years) effects on urinary quality of life
Timepoint [1] 446876 0
At 6, 9, 12, 18, 24, 36, 48 and 60 months post- completion SABR treatment (cumulative)
Secondary outcome [2] 446877 0
Acute (<3 months) genitourinary (GU) toxicity
Timepoint [2] 446877 0
End of treatment, and 4 weeks and 3 months post-completion of SABR treatment (cumulative)
Secondary outcome [3] 446880 0
Late (>6 months to 5 years) GU toxicity
Timepoint [3] 446880 0
At 6, 9, 12, 18, 24, 36, 48 and 60 months post- completion SABR treatment (cumulative)
Secondary outcome [4] 446881 0
Acute (<3 months) bowel quality of life. This will be assessed as a composite outcome
Timepoint [4] 446881 0
4 weeks and 3 months post-completion of SABR treatment (cumulative)
Secondary outcome [5] 446882 0
Late (>6 months to 5 years) effects on bowel quality of life
Timepoint [5] 446882 0
At 6, 9, 12, 18, 24, 36, 48 and 60 months post- completion SABR treatment (cumulative)
Secondary outcome [6] 446883 0
Acute (< 3 months) sexual quality of life. This will be assessed as a composite outcome
Timepoint [6] 446883 0
4 weeks and 3 months post-completion of SABR treatment (cumulative)
Secondary outcome [7] 446884 0
Late (>6 months to 5 years) effects on sexual quality of life
Timepoint [7] 446884 0
At 6, 9, 12, 18, 24, 36, 48 and 60 months post- completion SABR treatment (cumulative)
Secondary outcome [8] 446885 0
Acute (<3 months) gastrointestinal (GI) toxicity
Timepoint [8] 446885 0
End of treatment, and 4 weeks and 3 months post-completion of SABR treatment (cumulative)
Secondary outcome [9] 446886 0
Late (>6 months to 5 years) GI toxicity
Timepoint [9] 446886 0
At 6, 9, 12, 18, 24, 36, 48 and 60 months post- completion SABR treatment (cumulative)
Secondary outcome [10] 446887 0
Acute (<3 months) toxicity on sexual function
Timepoint [10] 446887 0
End of treatment, and 4 weeks and 3 months post-completion of SABR treatment (cumulative)
Secondary outcome [11] 446888 0
Late (>6 months to 5 years) toxicity on sexual function
Timepoint [11] 446888 0
At 6, 9, 12, 18, 24, 36, 48 and 60 months post- completion SABR treatment (cumulative)
Secondary outcome [12] 446889 0
Prostate Specific Antigen (PSA) response
Timepoint [12] 446889 0
At 48 months post SABR treatment
Secondary outcome [13] 446890 0
Biochemical disease free survival
Timepoint [13] 446890 0
Baseline and 3, 6, 9, 12, 18. 24, 36, 48, and 60 months post-completion of SABR treatment
Secondary outcome [14] 446891 0
Use of subsequent salvage androgen deprivation therapy (ADT)
Timepoint [14] 446891 0
Determined during follow-up at 3, 6, 9, 12, 18. 24, 36, 48, and 60 months post-completion of SABR treatment
Secondary outcome [15] 447221 0
Late (>6 months to 5 years) effects on urinary quality of life
Timepoint [15] 447221 0
At 6, 9, 12, 18, 24, 36, 48 and 60 months post- completion SABR treatment (cumulative)
Secondary outcome [16] 447226 0
Late (>6 months to 5 years) effects on bowel quality of life
Timepoint [16] 447226 0
At 6, 9, 12, 18, 24, 36, 48 and 60 months post- completion SABR treatment (cumulative)
Secondary outcome [17] 447227 0
Late (>6 months to 5 years) effects on sexual quality of life
Timepoint [17] 447227 0
At 6, 9, 12, 18, 24, 36, 48 and 60 months post- completion SABR treatment (cumulative)

Eligibility
Key inclusion criteria
- Histologically confirmed intermediate risk prostate cancer (at least one intermediate risk features i.e., International Society of Urological Pathology (ISUP) Grade Group 2-3, serum PSA 10-20 ng/mL, or clinical T2b/c; and no high-risk features i.e., ISUP Grade Group >/=4, serum PSA >/=20 ng/mL, clinical stage T3/4)
Eastern Cooperative Oncology Group (ECOG) 0-2
Capacity to consent to treatment and comply with follow-up schedule and completion of toxicity and QOL questionnaires
Minimum age
18 Weeks
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
- Any NCCN high risk features (i.e., ISUP Grade Group >/=4, serum PSA >/=20 ng/mL, clinical stage T3/4), or evidence of nodal or distant metastatic disease on staging PSMA PET scan
- Peri-urethral disease
- Contraindications to Magnetic Resonance Imaging (MRI)
- Prior pelvic radiotherapy
- Prostate volume >100cc
- Severe obstructive lower urinary tract symptoms (IPSS >/=20)
- Bleeding diathesis or use of anti-coagulation that is unsafe to discontinue for fiducial marker insertion.
- Comorbidities which predispose to significant radiation therapy toxicities (e.g., inflammatory bowel disease)
- Unilateral or bilateral hip replacement or other pelvic metalwork that may cause artefact on diffusion-weighted magnetic resonance imaging.

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
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
26/05/2025
Actual
Date of last participant enrolment
Anticipated
31/12/2027
Actual
Date of last data collection
Anticipated
31/12/2032
Actual
Sample size
Target
38
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 318823 0
Hospital
Name [1] 318823 0
Alfred Health Radiation Oncology Centre
Country [1] 318823 0
Australia
Primary sponsor type
Hospital
Name
Alfred Health
Address
Country
Australia
Secondary sponsor category [1] 321271 0
None
Name [1] 321271 0
Address [1] 321271 0
Country [1] 321271 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317440 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 317440 0
Ethics committee country [1] 317440 0
Australia
Date submitted for ethics approval [1] 317440 0
02/04/2025
Approval date [1] 317440 0
07/05/2025
Ethics approval number [1] 317440 0

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

Contacts
Principal investigator
Name 141034 0
Prof Wee Loon Ong
Address 141034 0
Alfred Health Radiation Oncology, 55 Commercial Road, Melbourne 3002, VIC
Country 141034 0
Australia
Phone 141034 0
+61 3 90762360
Fax 141034 0
Email 141034 0
[email protected]
Contact person for public queries
Name 141035 0
Wee Loon Ong
Address 141035 0
Alfred Health Radiation Oncology, 55 Commercial Road, Melbourne 3002, VIC
Country 141035 0
Australia
Phone 141035 0
+61 3 90762360
Fax 141035 0
Email 141035 0
[email protected]
Contact person for scientific queries
Name 141036 0
Wee Loon Ong
Address 141036 0
Alfred Health Radiation Oncology, 55 Commercial Road, Melbourne 3002, VIC
Country 141036 0
Australia
Phone 141036 0
+61 3 90762360
Fax 141036 0
Email 141036 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.