Actively Recruiting
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
Eligibility Criteria
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
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
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
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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