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RecruitingLast updated: 4 June 2025

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

Trial purpose

Medical clipboardCancer treatment

Tumor type

Urinary System Cancers Genitourinary

Age

People18+

Trial acronym

TRUST

Clinical summary

Summary

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

Traditional radiotherapy for intermediate risk prostate cancer typically involves 4 weeks of daily treatment. Recent studies have shown that using fewer but larger doses of radiation, i.e. 5-treatment stereotactic ablative radiotherapy (SABR), is just as effective and safe, and this has now become one of the standard radiation schedule options 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 II trial of urethra-sparing prostate SABR, researchers aim to evaluate the efficacy, toxicity, and quality of life outcomes of this treatment.

Eligible participants will receive SABR to the prostate, delivered in 5 fractions, 2-3 fractions per week. 

Conditions

This trial is treating people with intermediate risk prostate cancer

Eligibility

Inclusion

- 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

- 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.

Inclusion

  • Your cancer has not spread to other parts of the body (localised).

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ANZCTR *. View further details about this trial on the registry via the links below:

Trial sponsor

Alfred Health

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.

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