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RecruitingLast updated: 3 April 2025

2SHOTS: This study is recruiting people with localised prostate cancer to see if fewer radiation therapy sessions work as well as the standard treatment2-fraction Stereotactic ultra-HypOfractionated radiation Therapy of the proState, 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

2SHOTS

Clinical summary

Summary

This study aims to evaluate the toxicity and outcomes associated with a type of radiotherapy (SABR) in participants with localised prostate cancer.

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. 

Researchers want to know whether they can further reduce the number of treatments for prostate SABR while maintaining the cancer control rate and minimising side effects.

You may be eligible to join this study if you are aged 18 years or above, and have intermediate risk localised prostate cancer with no histological evidence of nodal or distant metastatic disease. Participants will recieve radiotherapy in 2 fractions, one week apart. 

Conditions

This trial is treating people with localised prostate cancer.

Eligibility

Inclusion

  • Males 18 years or over. 
  • 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 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 quality of life (QOL) questionnaires

Exclusion

  • Any National Comprehensive Cancer Network (NCCN) high risk features (i.e., ISUP Grade Group >/=4, serum PSA >/=20 ng/mL, clinical T3/4), or evidence of nodal or distant metastatic disease on staging prostate-specific membrane antigen (PSMA) positron emission tomography (PET)
    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 and rectal-spacing gel 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

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

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