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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]

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

Condition category

Condition code

Cancer

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]

Treatment: Other

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Acute (<3 months) effects on urinary quality of life. This will be assessed as a composite outcome.

Timepoint [1]

4 weeks and 3 months post completion of SABR treatment (cumulative)

Secondary outcome [1]

Late (>6 months to 5 years) effects on urinary quality of life

Timepoint [1]

At 6, 9, 12, 18, 24, 36, 48 and 60 months post- completion SABR treatment (cumulative)

Secondary outcome [2]

Acute (<3 months) genitourinary (GU) toxicity

Timepoint [2]

End of treatment, and 4 weeks and 3 months post-completion of SABR treatment (cumulative)

Secondary outcome [3]

Late (>6 months to 5 years) GU toxicity

Timepoint [3]

At 6, 9, 12, 18, 24, 36, 48 and 60 months post- completion SABR treatment (cumulative)

Secondary outcome [4]

Acute (<3 months) bowel quality of life. This will be assessed as a composite outcome

Timepoint [4]

4 weeks and 3 months post-completion of SABR treatment (cumulative)

Secondary outcome [5]

Late (>6 months to 5 years) effects on bowel quality of life

Timepoint [5]

At 6, 9, 12, 18, 24, 36, 48 and 60 months post- completion SABR treatment (cumulative)

Secondary outcome [6]

Acute (< 3 months) sexual quality of life. This will be assessed as a composite outcome

Timepoint [6]

4 weeks and 3 months post-completion of SABR treatment (cumulative)

Secondary outcome [7]

Late (>6 months to 5 years) effects on sexual quality of life

Timepoint [7]

At 6, 9, 12, 18, 24, 36, 48 and 60 months post- completion SABR treatment (cumulative)

Secondary outcome [8]

Acute (<3 months) gastrointestinal (GI) toxicity

Timepoint [8]

End of treatment, and 4 weeks and 3 months post-completion of SABR treatment (cumulative)

Secondary outcome [9]

Late (>6 months to 5 years) GI toxicity

Timepoint [9]

At 6, 9, 12, 18, 24, 36, 48 and 60 months post- completion SABR treatment (cumulative)

Secondary outcome [10]

Acute (<3 months) toxicity on sexual function

Timepoint [10]

End of treatment, and 4 weeks and 3 months post-completion of SABR treatment (cumulative)

Secondary outcome [11]

Late (>6 months to 5 years) toxicity on sexual function

Timepoint [11]

At 6, 9, 12, 18, 24, 36, 48 and 60 months post- completion SABR treatment (cumulative)

Secondary outcome [12]

Prostate Specific Antigen (PSA) response

Timepoint [12]

At 48 months post SABR treatment

Secondary outcome [13]

Biochemical disease free survival

Timepoint [13]

Baseline and 3, 6, 9, 12, 18. 24, 36, 48, and 60 months post-completion of SABR treatment

Secondary outcome [14]

Use of subsequent salvage androgen deprivation therapy (ADT)

Timepoint [14]

Determined during follow-up at 3, 6, 9, 12, 18. 24, 36, 48, and 60 months post-completion of SABR treatment

Secondary outcome [15]

Late (>6 months to 5 years) effects on urinary quality of life

Timepoint [15]

At 6, 9, 12, 18, 24, 36, 48 and 60 months post- completion SABR treatment (cumulative)

Secondary outcome [16]

Late (>6 months to 5 years) effects on bowel quality of life

Timepoint [16]

At 6, 9, 12, 18, 24, 36, 48 and 60 months post- completion SABR treatment (cumulative)

Secondary outcome [17]

Late (>6 months to 5 years) effects on sexual quality of life

Timepoint [17]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Alfred Health Radiation Oncology Centre

Address [1]

Country [1]

Australia

Primary sponsor type

Hospital

Name

Alfred Health

Address

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Alfred Hospital Ethics Committee

Ethics committee address [1]

https://www.alfredhealth.org.au/research/ethics-research-governance

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

02/04/2025

Approval date [1]

07/05/2025

Ethics approval number [1]

Summary

Brief summary

The study aims to evaluate the toxicity and quality of life outcomes associated with urethra-sparing prostate stereotactic ablative radiotherapy (SABR) for intermediate risk prostate cancer.

Who is it for?
You may be eligible to join this study if you are aged 18 years or above and have intermediate risk prostate cancer.

Study details:
Traditional radiotherapy for intermediate risk prostate cancer typically involves four weeks of daily treatment. Recent studies have shown that using fewer but larger doses of radiation, i.e. 5-treatment SABR, is just as effective and safe, and this has now become one of the standard radiation schedule option for men with intermediate risk prostate cancer. The question then is whether we can further reduce treatment-related toxicities while maintaining cancer control. In this Australian phase 2 trial of urethra-sparing prostate SABR, we aim to evaluate the efficacy, toxicity, quality of life outcomes of this treatment

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Wee Loon Ong

Address

Alfred Health Radiation Oncology, 55 Commercial Road, Melbourne 3002, VIC

Country

Australia

Phone

+61 3 90762360

Fax

[email protected]

Contact person for public queries

Name

Wee Loon Ong

Address

Alfred Health Radiation Oncology, 55 Commercial Road, Melbourne 3002, VIC

Country

Australia

Phone

+61 3 90762360

Fax

[email protected]

Contact person for scientific queries

Name

Wee Loon Ong

Address

Alfred Health Radiation Oncology, 55 Commercial Road, Melbourne 3002, VIC

Country

Australia

Phone

+61 3 90762360

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

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.

Trial Review

Documents added manually

Documents added automatically