Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000651886
Ethics application status
Approved
Date submitted
11/12/2020
Date registered
31/05/2021
Date last updated
13/05/2022
Date data sharing statement initially provided
31/05/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
68Gallium-Prostate Specific Membrane Antigen (68Ga-PSMA) Positron Emission Tomography (PET) as a potential Imaging biomarker post tyrosine kinase inhibition of metastatic clear cell Renal cell Carcinoma (PIRC) – a pilot study
Scientific title
68Ga-PSMA PET as a potential Imaging biomarker post tyrosine kinase inhibition of metastatic clear cell Renal cell Carcinoma (PIRC) – a pilot study
Secondary ID [1] 303008 0
ONJ2021-001
Universal Trial Number (UTN)
Trial acronym
The PIRC study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
clear cell renal cell carcinoma 320066 0
Condition category
Condition code
Cancer 317995 317995 0 0
Kidney

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Following enrollment on study, 68 Gallium radiolabelled PSMA ligand will be administered by intravenous infusion followed by a Positron Emission Tomography (PET) scan at baseline (prior to standard of care TKI treatment), at 4 weeks and 12 weeks. 68Ga-PSMA (200MBq) will be administered by a nuclear medicine physician, PET images will be acquired by nuclear medicine technicians at the site. Total administered dose will be quantified and recorded by subtraction of residual dose (in infusion equipment). PET images will be reviewed to confirm target lesion uptake. Standard of care activities include: computed tomography (CT) scans at baseline and approx. 12 weeks (+/- 7 days), haematology/biochemistry (up to 28 days before starting on study), physical exam and analysis of performance status.
Intervention code [1] 319295 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 325997 0
Baseline individual tumour uptake of 68Ga-PSMA in patients with metastatic ccRCC as assessed by Standardised Uptake Value (SUV) during PET scans.
Timepoint [1] 325997 0
Baseline.
Secondary outcome [1] 389809 0
Concordance of early (4 week) and standard (12 week) 68Ga-PSMA PET scan responses (in accordance with PERCIST 1.0 criteria) with conventional CT restaging at 12 weeks (in accordance with RECIST 1.1 criteria)..
Timepoint [1] 389809 0
Baseline, week 4 and 12 weeks post enrolment.
Secondary outcome [2] 391037 0
International Metastatic RCC Database Consortium (IMDC) risk score using blood samples and medical record information.
Timepoint [2] 391037 0
From enrollment on study to 12 months followup.

Eligibility
Key inclusion criteria
-18 years of age or older

- histologically confirmed unresectable/metastatic clear-cell renal cell carcinoma; variant-histology allowed as long as a clear-cell component comprises >50% of the tumour.

- previous treatment with at least one anti-VEGF TKI, with radiographic disease progression (by RECIST 1.1) confirmed whilst on or within 6 months of this treatment. Previous treatment(s) with an ICI, chemotherapy or, cytokine therapy, allare permitted.

- planned for commencement of a subsequent anti-VEGF TKI treatment as monotherapy.

- at least one measurable lesion by RECIST 1.1, not treated or planned for treatment by external beam radiation therapy.

- adequate kidney/liver function: bilirubin < 1.5 x ULN, AST/ALT < 2.5 x ULN, Creatinine < 1.5 x ULN

- able to tolerate PET scan procedures

- life expectancy > 3 months as estimated by the investigator

- no history of other active malignancies in prior 2 years
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- not eligible for a subsequent anti-VEGF TKI therapy in the opinion of the treating clinician, due to any reason

- about to commence treatment with anti-VEGF TKI therapy in combination with another therapy (e.g. other pathway inhibitor or ICI)

- previous adverse reaction to 68Ga-PSMA

- not able to provide informed consent

- pregnant or currently lactating

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised 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
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The primary outcome of the PIRC study is to assess the baseline PSMA positivity in the target population.

These results will be summarised descriptively with:

-Maximum target lesion SUVmax (range, median, interquartile range)

-Mean SUVmax of top 5 target lesions (range, median, interquartile range)

-% SUVmax >5 and >10 (with 95% confidence intervals)

The secondary outcome of the PIRC study is to assess the degree of (dis)agreement between PSMA response assessment (at week 4 and at week 12) and RECIST 1.1 radiographic restaging criteria.

Cohen’s kappa test will be used to measure inter-modality agreement between PSMA and RECIST 1.1 response.



The tertiary outcome relates to whether baseline PSMA positivity is associated with a) IMDC risk score and b) subsequent response by RECIST 1.1, or vice versa.

This association will be compared using appropriate non-parametric tests for comparison of two medians (Mann Whitney U test), comparison of three medians (Kruskal Wallis test) comparison of two binary variables (Chi square or Fisher’s exact test) or three binary variables (Pearson Chi square test).

This is an exploratory measure and any result will be treated as hypothesis-generating only.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
4/10/2021
Actual
31/01/2022
Date of last participant enrolment
Anticipated
1/03/2023
Actual
Date of last data collection
Anticipated
30/05/2024
Actual
Sample size
Target
20
Accrual to date
20
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 18189 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment hospital [2] 18190 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 32246 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 32247 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 307416 0
Other Collaborative groups
Name [1] 307416 0
Australian and New Zealand Urogenital and Prostate Cancer Trials Group
Country [1] 307416 0
Australia
Primary sponsor type
Other
Name
Olivia Newton-John Cancer Research Institute
Address
Level 5, ONJCWRC
145 Studley Road
Heidelberg 3084
VICTORIA
Country
Australia
Secondary sponsor category [1] 308085 0
None
Name [1] 308085 0
Address [1] 308085 0
Country [1] 308085 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307501 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 307501 0
Ethics committee country [1] 307501 0
Australia
Date submitted for ethics approval [1] 307501 0
27/01/2021
Approval date [1] 307501 0
09/06/2021
Ethics approval number [1] 307501 0
HREC/72257/Austin-2021

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

Contacts
Principal investigator
Name 107458 0
A/Prof Andrew Weickhardt
Address 107458 0
Medical Oncology
Austin Health
145 Studley Road
Heidelberg VIC 3084
Country 107458 0
Australia
Phone 107458 0
+61 394969923
Fax 107458 0
NA
Email 107458 0
andrew.weickhardt@austin.org.au
Contact person for public queries
Name 107459 0
Jodie Palmer
Address 107459 0
Olivia Newton-John Cancer Research Institute
Level 5, ONJWRC
145 Studley Road
Heidelberg VIC 3084
Country 107459 0
Australia
Phone 107459 0
+61 3 94963573
Fax 107459 0
NA
Email 107459 0
trials@onjcri.org.au
Contact person for scientific queries
Name 107460 0
Jodie Palmer
Address 107460 0
Olivia Newton-John Cancer Research Institute
Level 5, ONJWRC
145 Studley Road
Heidelberg VIC 3084
Country 107460 0
Australia
Phone 107460 0
+61 3 94963573
Fax 107460 0
NA
Email 107460 0
trials@onjcri.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Consent to share has not been requested from the participants. This is a small pilot study and there is limited reason for data sharing/release outside of publications.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.