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RecruitingLast updated: 29 April 2026

STARWARS: A study recruiting people with locally recurrent prostate cancer to assess if salvage re-irradiation with SABR is a safe and feasible management optionSalvage sTereotactic Ablative radiotherapy for patients with Recurrent prostate cancer With Androgen suppression and Rectal Spacer, assessing toxicity and quality of life

Trial purpose

Medical clipboardCancer treatment

Tumor type

Urinary System Cancers Genitourinary

Age

People18+

Trial acronym

STARWARS

Clinical summary

Summary

This study aims to assess if salvage re-irradiation with stereotactic ablative body radiation therapy (SABR) is a safe and feasible management option for locally recurrent prostate cancer.

Who is it for?
You may be eligible to join this study if you are aged 18 years or above and have locally recurrent prostate cancer following prior radiation therapy to the prostate.

Study details
All participants in this study will receive prostate SABR re-irradiation (over 5 fractions) and 6 months of androgen deprivation therapy (ADT).

At baseline, participants will require imaging, blood tests, and questionnaire completion. Further blood tests will be required every 6 months up to 5 years post treatment, and at 2 years, some participants will require a further biopsy while all participants will require MRI scans.

The findings will help guide clinicians on whether prostate SABR re-irradiation is a safe and effective option for this group of patients who currently have limited evidence-based local salvage treatment options.

 

Conditions

This trial is treating people with locally recurrent prostate cancer

Eligibility

Inclusion

- Histologically confirmed locally recurrent prostate cancer
- Recurrence at least 2 years after completion 

- Histologically confirmed locally recurrent prostate cancer
- Recurrence at least 2 years after completion of previous curative intent definitive prostate radiation therapy (2 years from end date of androgen deprivation therapy if androgen deprivation therapy was given with prostate radiation therapy)
- Able to undergo pre-treatment multiparametric magnetic resonance imaging (mpMRI) and prostate specific membrane antigen positron emission tomography/ computed tomography
(PSMA-PET/CT)

- Capacity to consent to treatment and comply with follow-up schedule and completion of toxicity and QOL questionnairesof previous curative intent definitive prostate radiation therapy (2 years from end date of androgen deprivation therapy if androgen deprivation therapy was given with prostate radiation therapy)
- Able to undergo pre-treatment multiparametric magnetic resonance imaging (mpMRI) and prostate specific membrane antigen positron emission tomography/ computed tomography
(PSMA-PET/CT)
- Capacity to consent to treatment and comply with follow-up schedule and completion of toxicity and QOL questionnaires

Exclusion

- Poor baseline urinary function (IPSS>20)
- Contraindication to MRI or PSMA-PET/CT
- Poor baseline urinary function (IPSS>20)
- Contraindication to MRI or PSMA-PET/CT
- Contraindication to gold-fiducial insertion or rectal spacer insertion
- Anticoagulation medication use (that is unsafe to be discontinued for fiducial marker and rectal spacer insertion)
- Bleeding diathesis (that is unsafe for fiducial marker and rectal spacer insertion)
- Evidence of pelvic nodal disease or distant metastasis on PSMA-PET/CT
- Prior ultra-hypofractionated radiation therapy (>5 Gy/ fraction)
- Castrate resistant prostate cancer – defined as PSA >3 ng/ml while testosterone <0.7nmol/l)- Contraindication to gold-fiducial insertion or rectal spacer insertion
- Anticoagulation medication use (that is unsafe to be discontinued for fiducial marker and rectal spacer insertion)
- Bleeding diathesis (that is unsafe for fiducial marker and rectal spacer insertion)
- Evidence of pelvic nodal disease or distant metastasis on PSMA-PET/CT
- Prior ultra-hypofractionated radiation therapy (>5 Gy/ fraction)
- Castrate resistant prostate cancer – defined as PSA >3 ng/ml while testosterone <0.7nmol/l)

Inclusion

  • You have had treatment, but your cancer has come back (relapsed or recurrent).
  • Your cancer has not spread to other parts of the body (localised).
  • You have had a certain type of treatment or surgical procedure.

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

Salvage sTereotactic Ablative radiotherapy for patients with Recurrent prostate cancer With Androgen suppression and Rectal Spacer, assessing toxicity and quality of life

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