Phase 2 study for people with Prostate Cancer

Recruiting Phase 2

Sources: ClinicalTrials.gov Checked: 11 October 2026 Not medical advice

This trial at a glance

Status Recruiting
Phase Phase 2
Sponsor Peter MacCallum Cancer Centre, Australia
Registry number NCT05560659
Started 14 December 2023 Today 16 October 2026 Estimated completion 1 May 2026

Past estimated completion. The registry still lists this trial as open, and the date it gave for finishing has been and gone. Confirm with the official record before you act on it.

Where this trial is running

Trial sites and the status recorded for each
SiteCityState or countryStatus at this site
Royal North Shore St Leonards NSW Recruiting
Peter MacCallum Cancer Centre Melbourne VIC Recruiting

voxsanity.com.au · trial sites from public registries · registry record synced 11 October 2026 · not medical advice

Who can join

Age 18 Years and over
Sex Male participants only
Healthy volunteers Not accepted
Enrolment target 92

The official eligibility criteria

Registry text, reproduced exactly. These are the words the trial's sponsor published on ClinicalTrials.gov. They have not been edited, shortened or rewritten, and they are written for researchers rather than for patients.

Inclusion Criteria:

1. Male aged 18 years or older at screening

2. Patient has provided written informed consent

3. Histologically confirmed prostate adenocarcinoma w

4. Prior definitive treatment of the primary with either curative intent radiotherapy and/or surgery

5. Patient has 1-5 sites of nodal or bony metastases on 68Ga-PSMA or 18F-DCFPyL PET/CT

6. Adequate haematological function as defined by:

* Absolute neutrophil count (ANC) ≥1.5 x 109/L

* Platelet count \>150x 109/L

* Haemoglobin ≥100 g/L

* Creatinine Clearance ≥ 40mL/min (Cockcroft-Gault formula)

7. Assessed as suitable for SABR by a radiation oncologist

8. Patients must agree to use an adequate method of contraception

9. Have a performance status of 0-1 on the ECOG Performance Scale

Exclusion Criteria:

1. Prior systemic therapy for metastatic prostate cancer. Prior ADT is allowed but ADT within 6 months of screening for the study is not allowed. If patients have received prior ADT, serum testosterone levels must be above the lower limit of normal

2. Any visceral (AJCCC M1c) metastases

3. Symptomatic cord compression, or clinical or imaging findings concerning for impending cord compression

4. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating Investigator

5. Has a known additional malignancy that is progressing or required active treatment in the last 2 years Note: Basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer or carcinoma in situ such as breast cancer in situ that has undergone potentially curative therapy are not excluded.

Dates on the record

Started 14 December 2023
Estimated completion 1 May 2026
Registry last updated 11 July 2025
Checked by Voxsanity 11 October 2026

Results, publications and the official record

Sources and dates

  • ClinicalTrials.gov – the record this page reformats
  • ClinicalTrials.gov processing date: 11 July 2025.
  • This page last checked by Voxsanity: 11 October 2026.

Voxsanity reformats data from public registries into this layout. It does not edit, interpret or add to what the registry published.

Not medical advice.

Individual trial records are refreshed on a rolling basis rather than all at once, so a record may be up to several weeks old. Each trial page and trial card shows the date its own record was last synced. Where a record has lagged, its status, sites and enrolment can differ from the current registry state in either direction, so check the registry link on the trial page before acting on them.

Letter for your doctor

A one-page summary of this trial to print or email to your GP. It carries the registry's own record of the trial and its eligibility criteria, and nothing Voxsanity has written about whether it suits you.