Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
MY TRIALS
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Register a trial
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05560659
Registration number
NCT05560659
Ethics application status
Date submitted
17/02/2022
Date registered
29/09/2022
Titles & IDs
Public title
Lu-PSMA for Oligometastatic Prostate Cancer Treated With STereotactic Ablative Radiotherapy
Query!
Scientific title
Lu-PSMA for Oligometastatic Prostate Cancer Treated With STereotactic Ablative Radiotherapy, a Randomised Phase II Parallel Cohort Trial
Query!
Secondary ID [1]
0
0
20/033
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
POPSTAR II
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Oligometastatic Prostate Cancer
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Prostate
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - 177Lu-PSMA
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
Treatment: Drugs: 177Lu-PSMA
Lutetium-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
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Evaluate the (bPFS) of SABR alone and SABR + 177Lu-PSMA
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
Through study completion, up until 12 months after the last patient commences treatment
Query!
Secondary outcome [1]
0
0
The AEs according to CTCAE v5.0
Query!
Assessment method [1]
0
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
Query!
Timepoint [1]
0
0
Through study completion, up until 4 months ± 10 days from the commencement of ADT following progression
Query!
Secondary outcome [2]
0
0
The PSA-response rate
Query!
Assessment method [2]
0
0
PSA response will be defined as a 50% or greater decrease in PSA from baseline to the lowest post-baseline PSA result
Query!
Timepoint [2]
0
0
Through study completion, up until time of biochemical progression +/- 10 days
Query!
Secondary outcome [3]
0
0
The ADT-free survival
Query!
Assessment method [3]
0
0
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
Query!
Timepoint [3]
0
0
Through study completion, up until biochemical progression +/- 10 days
Query!
Secondary outcome [4]
0
0
The pattern of recurrence on PSMA PET
Query!
Assessment method [4]
0
0
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)
Query!
Timepoint [4]
0
0
Time of biochemical progression +/-10 days
Query!
Secondary outcome [5]
0
0
The patient reported quality of life
Query!
Assessment method [5]
0
0
QoL will be assessed using the EORTC QLQC-30 and EQ-5D-5L questionnaires
Query!
Timepoint [5]
0
0
From the date of randomisation to the date of progression
Query!
Secondary outcome [6]
0
0
The MDT PFS
Query!
Assessment method [6]
0
0
MDT PFS is defined as the time from first MDT after initial treatment to first documented subsequent disease progression (biochemical, or clinical using the same definition as the primary endpoint) or date of death, whichever comes first. Only patients who received MDT as the only treatment modality after initial treatment will be included.
Query!
Timepoint [6]
0
0
Time point after Cycle 2 (28 days follow up post Cycle 2) until biochemical progression
Query!
Secondary outcome [7]
0
0
The overall survival
Query!
Assessment method [7]
0
0
OS is defined as the time from randomisation to the date of death from any cause
Query!
Timepoint [7]
0
0
Time point post randomisation to the date of death from any cause
Query!
Secondary outcome [8]
0
0
Healthcare costs associated with delivering the intervention and management of AEs
Query!
Assessment method [8]
0
0
Health economic analysis is planned to assess the real-world cost-effectiveness and broader economic impact of using 177Lu-PSMA + SABR compared to SABR alone (if an effect is observed). Costs included in the analysis will focus on those relevant to the intervention (177Lu-PSMA) including treatment-related hospitalisations, clinic visits, PSMA PET scans, and associated medical service utilisation. Additionally, healthcare resource used and their associated costs including those associated with the complications arising from each study arm will be extracted from hospital administrative records and data collected during the trial (e.g., CTCAE v 5.0 Toxicity Record) and compared to provide an understanding of overall costs.
Query!
Timepoint [8]
0
0
Through study completion, an average of 3 years
Query!
Secondary outcome [9]
0
0
The PET-PFS
Query!
Assessment method [9]
0
0
PET-PFS is defined as the time from randomisation to the date of radiological progression on PSMA PET/CT scan or death due to any cause, whichever comes first. Patients alive without a rise in PSA will be censored at last PSA assessment
Query!
Timepoint [9]
0
0
Through study completion, from the date of randomisation to the date of radiological progression or death from any cause, whichever comes first.
Query!
Eligibility
Key inclusion criteria
1. Male aged 18 years or older at screening
2. Patient has provided written informed consent
3. Histologically confirmed prostate adenocarcinoma w
4. Prior definitive treatment of the primary with either curative intent radiotherapy and/or surgery
5. Patient has 1-5 sites of nodal or bony metastases on 68Ga-PSMA or 18F-DCFPyL PET/CT with a score of 4 or 5 as defined by the E-PSMA criteria
6. At least one site of disease with SUVmax twice the SUVmax of liver on PSMA PET (Ga-68 PSMA 11 or F-18 DCFPYL tracers only)
7. 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)
8. Assessed as suitable for SABR by a radiation oncologist
9. Patients must agree to use an adequate method of contraception
10. Have a performance status of 0-1 on the ECOG Performance Scale
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Males
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
1. 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
2. No sites of PSMA negative metastatic disease evident on CT/bone scan
3. Any visceral (AJCCC M1c) metastases
4. Symptomatic cord compression, or clinical or imaging findings concerning for impending cord compression
5. 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
6. 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.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 2
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
14/12/2023
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
1/05/2026
Query!
Actual
Query!
Sample size
Target
92
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
VIC
Query!
Recruitment hospital [1]
0
0
Peter MacCallum Cancer Centre - Melbourne
Query!
Recruitment postcode(s) [1]
0
0
3000 - Melbourne
Query!
Funding & Sponsors
Primary sponsor type
Other
Query!
Name
Peter MacCallum Cancer Centre, Australia
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Commercial sector/industry
Query!
Name [1]
0
0
Varian Medical Systems
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief 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.
Query!
Trial website
https://clinicaltrials.gov/study/NCT05560659
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
A/Prof. Shankar Siva
Query!
Address
0
0
Peter MacCallum Cancer Centre, Australia
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Gaurav Sharma
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
+61 3 8559 6830
Query!
Fax
0
0
Query!
Email
0
0
[email protected]
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
Query!
No/undecided IPD sharing reason/comment
Individual requests for data sharing must be accompanied by ethical approval and will be considered at request
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05560659