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RecruitingLast updated: 23 September 2025

SNIPER: This study is recruiting people with high risk and/or node positive prostate cancer to evaluate the effectiveness, toxicity and quality of life outcomes of 5-fraction stereotactic ablative radiotherapyStereotactic ablative body radiation therapy with nodal irradiation of prostate cancer, assessing toxicities and quality of life in patients with high risk and/or node positive prostate cancer

Trial purpose

Medical clipboardCancer treatment; Side effect and wellbeing

Tumor type

Urinary System Cancers Genitourinary

Age

People18+

Trial acronym

SNIPER

Clinical summary

Summary

Traditional radiation therapy for high risk and/or node positive prostate cancer typically involves 4-8 weeks of daily treatment with androgen deprivation therapy. 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 radiotherapy schedules for intermediate risk prostate cancer.

The question then is whether we can further reduce the number of treatments for prostate SABR while maintaining the cancer control rate and minimising side effects for high risk and/or node positive prostate cancer. This is an appealing option from a patient convenience and healthcare cost-saving point of view.

In this Australian Phase II trial of 5-treatment prostate and pelvic SABR, we aim to evaluate the efficacy, toxicity and quality of life outcomes of this treatment.

Participants will receive SABR to the prostate and pelvic lymph nodes, delivered in five fractions, one fraction per week. 

The study will recruit two cohorts of participants:

  • Cohort A: high-risk node negative prostate cancer
  • Cohort B: node-positive non-metastatic prostate cancer.

Conditions

This trial is treating people with prostate cancer that is either intermediate risk or pelvic node positive

Eligibility

Inclusion

Either
- Cohort A: Histologically confirmed intermediate risk prostate cancer (at least one high risk feature i.e. International Society of Urological Pathology (ISUP) Grade group >/= 4, serum PSA >/= 20ng/mL, clinical stage T3/4.
- Cohort B: PSMA PET confirmed pelvic node positive prostate cancer, up to 5 involved nodes.
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) questionnaire

Exclusion

- Metastatic disease outside of pelvis (i.e. M1a, M1b, or M1c) on PSMA PET staging
- Contraindications to Magnetic Resonance Imaging (MRI)
- Prior pelvic radiotherapy or prior radical prostatectomy
- Prior pharmacologic androgen ablation for prostate cancer
- Prostate volume >100cc
- >5 pelvic lymph nodal involvement on PSMA-PET
- Severe obstructive lower urinary tract symptoms (International Prostate Symptom Score >/=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)
- Hip replacement or other pelvic metalwork that may cause artefact on diffusion-weighted magnetic resonance imaging.

Inclusion

  • Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
  • 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

Stereotactic ablative body radiation therapy with nodal irradiation of prostate cancer, assessing toxicities and quality of life in patients with high risk and/or node positive prostate cancer

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