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.
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
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
Any visceral (AJCCC M1c) metastases
Symptomatic cord compression, or clinical or imaging findings concerning for impending cord compression
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
Parallel
177Lu-PSMA
DrugLutetium-177 (177Lu)-PSMA is a radiopharmaceutical comprised of a small molecule inhibitor of PSMA that binds with high affinity to PSMA, labelled with 177Lu. 177Lu has favourable characteristics for radionuclide therapy emitting both a short-range (1-2mm) cytotoxic beta-particle, minimising irradiation of non-targeted normal tissues, alongside gamma emission that allows imaging. Numerous retrospective series initially demonstrated high clinical activity and limited normal tissue toxicity using PSMA-617 and PSMA-I\&T, which are the most advanced small molecule inhibitors of PSMA, radiolabelled with 177Lu
Evaluate the (bPFS) of SABR alone and SABR + 177Lu-PSMA
The biochemical progression free survival (bPFS) of SABR alone and SABR + 177Lu-prostate-specific membrane antigen (PSMA) in patients with oligometastatic prostate cancer undergoing PSMA positron emission tomography (PET) staging.
The AEs according to CTCAE v5.0
The type, grade and relationship to treatment of AEs will be assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v 5.0
The PSA-response rate
PSA response will be defined as a 50% or greater decrease in PSA from baseline to the lowest post-baseline PSA result
The ADT-free survival
ADT-FS is defined as the time from randomisation to the date of initiation of androgen deprivation therapy or date of death due to any cause
The pattern of recurrence on PSMA PET
Pattern of relapse will be evaluated on the PSMA PET at progression in relation to baseline PSMA PET, including: a) number of new sites of disease; b) location of new disease of disease (pelvic nodes, extra-pelvic nodes, bone, viscera); c) progression at prior sites (yes or no)
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Peter MacCallum Cancer Centre, Australia
Lead sponsor
Varian Medical Systems
Collaborator
