Actively Recruiting

Phase 2
Age: 18Years +
MALE
NCT05560659

Lu-PSMA for Oligometastatic Prostate Cancer Treated With STereotactic Ablative Radiotherapy

Led by Peter MacCallum Cancer Centre, Australia · Updated on 2025-07-11

92

Participants Needed

3

Research Sites

176 weeks

Total Duration

On this page

Sponsors

P

Peter MacCallum Cancer Centre, Australia

Lead Sponsor

V

Varian Medical Systems

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Lu-PSMA for Oligometastatic Prostate Cancer Treated With STereotactic Ablative Radiotherapy

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Male aged 18 years or older at screening
  • Patient has provided written informed consent
  • Histologically confirmed prostate adenocarcinoma
  • Prior definitive treatment of the primary tumor with curative intent radiotherapy and/or surgery
  • 1 to 5 sites of nodal or bone metastases on 68Ga-PSMA or 18F-DCFPyL PET/CT
  • Adequate blood counts: neutrophils 21.5 x 10^9/L, platelets >150 x 10^9/L, hemoglobin 100 g/L
  • Creatinine clearance 60 mL/min (Cockcroft-Gault formula)
  • Assessed as suitable for SABR by a radiation oncologist
  • Agreement to use effective contraception
  • ECOG performance status of 0 or 1
Not Eligible

You will not qualify if you...

  • Prior systemic therapy for metastatic prostate cancer, except androgen deprivation therapy (ADT) if not given within 6 months before screening and testosterone levels are normal
  • Presence of any visceral metastases (AJCCC M1c)
  • Symptomatic spinal cord compression or findings suggesting impending cord compression
  • Any condition, therapy, or lab abnormality that might interfere with trial participation or results, as judged by the investigator
  • Known additional malignancy progressing or requiring active treatment in the last 2 years, except certain treated skin or bladder cancers and breast cancer in situ

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

Royal North Shore

St Leonards, New South Wales, Australia, 2065

Actively Recruiting

2

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia, 3000

Actively Recruiting

3

Sheba Medical Centre

Tel Aviv, Israel

Actively Recruiting

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Research Team

G

Gaurav Sharma

CONTACT

A

Annette VanDerHeyden

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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