Efficacy of Toxicity Reduction with Urethra Sparing radiation Therapy for prostate cancer (TRUST)

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.

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12625000487415

Acronym

TRUST

Enrollment

Registered

2025-05-20

Start date

2025-05-26

Completion date

2027-12-31

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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

Interventions

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.

Study design

Allocation

Non-randomised trial

Primary purpose

Treatment

Eligibility

Sex/Gender

Male

Age

18 Weeks to No maximum

Healthy volunteers

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

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.

Outcome results