NCT05560659RecruitingPhase 2
Lu-PSMA for Oligometastatic Prostate Cancer Treated With STereotactic Ablative Radiotherapy
Lu-PSMA for Oligometastatic Prostate Cancer Treated With STereotactic Ablative Radiotherapy, a Randomised Phase II Parallel Cohort Trial
Source: ClinicalTrials.gov · Last updated 11 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The aim of this study is to assess the progression free survival (PFS) of SABR alone and SABR + 177Lu-prostate-specific membrane antigen (PSMA) in patients with oligometastatic prostate cancer undergoing PSMA positron emission tomography (PET) staging.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 92 (estimated)
- First submitted
- 17 Feb 2022
- Start date
- 14 Dec 2023
- Primary completion date
- May 2026
- Lead sponsor
- Peter MacCallum Cancer Centre, Australia
- Diseases
- Prostate cancer
- NCT number
- NCT05560659
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 92
- From 14 Dec 2023 to the primary completion date, May 2026
- 3 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Lab values
- 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
- 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
Other
- Any visceral (AJCCC M1c) metastases
- Symptomatic cord compression, or clinical or imaging findings concerning for impending cord compression
Who the study is looking for
- Male aged 18 years or older at screening
- Patient has provided written informed consent
- Histologically confirmed prostate adenocarcinoma w
- Prior definitive treatment of the primary with either curative intent radiotherapy and/or surgery
- Patient has 1-5 sites of nodal or bony metastases on 68Ga-PSMA or 18F-DCFPyL PET/CT
- 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)
- Assessed as suitable for SABR by a radiation oncologist
- Patients must agree to use an adequate method of contraception
- Have a performance status of 0-1 on the ECOG Performance Scale
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peter MacCallum Cancer Centre Coordinator of this site? Confirm its status | Melbourne | Australia | Recruiting |
| Royal North Shore Coordinator of this site? Confirm its status | St Leonards | Australia | Recruiting |
| Sheba Medical Centre Coordinator of this site? Confirm its status | Tel Aviv | Israel | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.