Lu-PSMA for Oligometastatic Prostate Cancer Treated With STereotactic Ablative Radiotherapy, a Randomised Phase II Parallel Cohort Trial

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Australia
Peter MacCallum Cancer Centre
RECRUITING
Melbourne
Royal North Shore
RECRUITING
St Leonards
Israel
Sheba Medical Centre
RECRUITING
Tel Aviv
Contact Information
Primary
Gaurav Sharma
Gaurav.Sharma@petermac.org
+61 3 8559 6830
Backup
Annette VanDerHeyden
Annette.VanDerHeyden@petermac.org
+61488048792
Time Frame
Start Date: 2023-12-14
Estimated Completion Date: 2027-05
Participants
Target number of participants: 92
Treatments
No_intervention: Stereotactic ablative body radiotherapy (SABR) alone
1-3 fractions of SABR to all sites of disease
Experimental: SABR plus 2 cycles of 177Lu-PSMA
cycles of 177Lu-PSMA with 1-3 fractions of SABR to all sites of disease between cycle 1 and 2
Related Therapeutic Areas
Sponsors
Leads: Peter MacCallum Cancer Centre, Australia
Collaborators: Varian Medical Systems

This content was sourced from clinicaltrials.gov