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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
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

Full criteria on ClinicalTrials.gov

Sites (3)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Peter MacCallum Cancer Centre
Coordinator of this site? Confirm its status
MelbourneAustraliaRecruiting
Royal North Shore
Coordinator of this site? Confirm its status
St LeonardsAustraliaRecruiting
Sheba Medical Centre
Coordinator of this site? Confirm its status
Tel AvivIsraelRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.