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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
Scientific title
Lu-PSMA for Oligometastatic Prostate Cancer Treated With STereotactic Ablative Radiotherapy, a Randomised Phase II Parallel Cohort Trial
Secondary ID [1] 0 0
20/033
Universal Trial Number (UTN)
Trial acronym
POPSTAR II
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Oligometastatic Prostate Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Evaluate the (bPFS) of SABR alone and SABR + 177Lu-PSMA
Timepoint [1] 0 0
Through study completion, up until 12 months after the last patient commences treatment
Secondary outcome [1] 0 0
The AEs according to CTCAE v5.0
Timepoint [1] 0 0
Through study completion, up until 4 months ± 10 days from the commencement of ADT following progression
Secondary outcome [2] 0 0
The PSA-response rate
Timepoint [2] 0 0
Through study completion, up until time of biochemical progression +/- 10 days
Secondary outcome [3] 0 0
The ADT-free survival
Timepoint [3] 0 0
Through study completion, up until biochemical progression +/- 10 days
Secondary outcome [4] 0 0
The pattern of recurrence on PSMA PET
Timepoint [4] 0 0
Time of biochemical progression +/-10 days
Secondary outcome [5] 0 0
The patient reported quality of life
Timepoint [5] 0 0
From the date of randomisation to the date of progression
Secondary outcome [6] 0 0
The MDT PFS
Timepoint [6] 0 0
Time point after Cycle 2 (28 days follow up post Cycle 2) until biochemical progression
Secondary outcome [7] 0 0
The overall survival
Timepoint [7] 0 0
Time point post randomisation to the date of death from any cause
Secondary outcome [8] 0 0
Healthcare costs associated with delivering the intervention and management of AEs
Timepoint [8] 0 0
Through study completion, an average of 3 years
Secondary outcome [9] 0 0
The PET-PFS
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.

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
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/12/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/05/2026
Actual
Sample size
Target
92
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 0 0
3000 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Peter MacCallum Cancer Centre, Australia
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Varian Medical Systems
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
A/Prof. Shankar Siva
Address 0 0
Peter MacCallum Cancer Centre, Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Gaurav Sharma
Address 0 0
Country 0 0
Phone 0 0
+61 3 8559 6830
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Individual requests for data sharing must be accompanied by ethical approval and will be considered at request


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