RecruitingACTRN12625000198426

2-fraction Stereotactic ultra-HypOfractionated radiation Therapy of the proState (2SHOTS)

2-fraction Stereotactic ultra-HypOfractionated radiation Therapy of the proState, assessing toxicities and quality of life in patients with intermediate risk prostate cancer


Sponsor

Alfred Health

Enrollment

30 participants

Start Date

Mar 26, 2025

Study Type

Interventional

Conditions

Summary

This study aims to evaluate the toxicity and quality of life outcomes (QOL) associated with 2-fraction stereotactic ablative radiotherapy (SABR) for localized 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 localised prostate cancer. Study details: Traditional radiotherapy for prostate cancer typically involves four to eight 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 radiotherapy schedules. The question then is whether we can further reduce the number of treatments for prostate SABR while maintaining the cancer control rate and minimizing side effects. This is an appealing option from a patient convenience and healthcare cost-saving point of view. In this Australian phase 2 trial of 2-treatment prostate SABR, we aim to evaluate the efficacy, toxicity and quality of life outcomes of 2-treatment prostate SABR.


Eligibility

Sex: MalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Prostate cancer is one of the most common cancers in men. Traditional radiotherapy involves weeks of daily treatment sessions, which can be time-consuming and burdensome. Recent advances have shown that delivering radiation in fewer but larger doses — called stereotactic ablative radiotherapy (SABR) — is equally effective. Standard prostate SABR uses 5 treatments. This study asks: can we do it in just 2? This Australian Phase 2 trial is testing 2-fraction SABR for men with intermediate-risk localised prostate cancer. Researchers will carefully monitor side effects (especially urinary and bowel symptoms) and quality of life to make sure this ultra-short approach is safe and doesn't compromise outcomes. If successful, it would make treatment far more convenient for patients and reduce healthcare costs. You may be eligible if you are a man aged 18 or older with intermediate-risk prostate cancer (certain PSA levels, Grade Group 2–3, or clinical stage T2b/c) and no signs of spread to nodes or distant sites. Men with severe urinary symptoms, prior pelvic radiation, prostate over 100cc, or contraindications to MRI are not eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

Patients will receive Stereotactic Ablative Radiotherapy (SABR) to the prostate, 26Gy in 2 fractions, one week apart. Treatment will be prescribed by radiation oncologist. Adherence to the interventi

Patients will receive Stereotactic Ablative Radiotherapy (SABR) to the prostate, 26Gy in 2 fractions, one week apart. Treatment will be prescribed by radiation oncologist. Adherence to the intervention will be assessed by review of medical records.


Locations(1)

The Alfred - Melbourne

VIC, Australia

View Full Details on ANZCTR

For the most up-to-date information, visit the official listing.

Visit

ACTRN12625000198426