Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000695505
Ethics application status
Approved
Date submitted
6/05/2024
Date registered
31/05/2024
Date last updated
31/05/2024
Date data sharing statement initially provided
31/05/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
A clinical study to investigate the infusion of an amino acids solution to protect the kidneys during radiotheranostics for patients diagnosed with metastatic prostate cancer.
Scientific title
A prospective, open-label, single center, two arms study of amino acids infusion as renal protection during Lutetium-177 PSMA-I&T therapy: renal dosimetry assessment in patients with metastatic castrate-resistant prostate cancer.
Secondary ID [1] 311879 0
TBA
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic renal injuries 333440 0
Metastatic castrate-resistant prostate cancer 333441 0
Condition category
Condition code
Cancer 330112 330112 0 0
Kidney
Cancer 330113 330113 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
a) 1000 mL of SYNTHAMIN 17 (Amino acids 10%) without electrolytes solution will be administered intravenously at a rate of 250 mL/h over a four-hour period.
b) The infusion will commence 30–60 minutes prior to Lutetium-177 PSMA-I&T therapy.
c) The infusion will be administered by a registered nurse.
d) Adherence will be monitored via patient observation, as well as recording the administration details in the Investigational Drug
e) There will be a 6-week interval between treatment cycles.
Intervention code [1] 328339 0
Prevention
Intervention code [2] 328340 0
Treatment: Drugs
Comparator / control treatment
The comparator will be Lutetium-177 PSMA-I&T treatment without amino acid infusion, assessing renal dosimetry using 3D SPECT CT imaging during treatment cycles 3, 4, or 5.
Control group
Active

Outcomes
Primary outcome [1] 337870 0
The primary endpoint is the comparative analysis of renal dosimetry, as quantified by 3D SPECT/CT imaging, following a cycle of Lutetium-177 PSMA-I&T therapy with a standard amino acid infusion (intervention cycle) versus the renal dosimetry obtained from the immediate preceding cycle without amino acid infusion (control cycle) in patients with metastatic castration-resistant prostate cancer.
Timepoint [1] 337870 0
The primary outcome (renal dosimetry) will be assessed at three specific time points post each Lutetium-177 PSMA-I&T therapy cycle (4 ±1 hour, 24 ±2 hours, and 120 ±24 hours), using planar imaging and 3D SPECT/CT.
Secondary outcome [1] 433543 0
Changes in serum creatinine and estimated glomerular filtration rate (eGFR) will be assessed as a composite outcome.
Timepoint [1] 433543 0
baseline and 6 weeks after each cycle

Eligibility
Key inclusion criteria
1. Male patients aged >18 yrs
2. History of histologically confirmed prostate cancer
3. Metastatic patients who are considered for ongoing treatment with 177Lu–PSMA-617
4. Ability to understand and the willingness to sign a written informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
1. Life expectancy less than 6 months
2. Unable to give informed consent
3. Unable to comply with required scanning schedule.
4. Other malignant tumors that are likely to express PSMA, such as salivary gland, renal or hepatocellular carcinoma

Study design
Purpose of the study
Prevention
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
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
This study will employ paired comparative analysis methods. A paired t-test (or non-parametric equivalent, such as the Wilcoxon signed-rank test for non-normally distributed variables) will be used to analyze the difference in renal dosimetry as measured by 3D SPECT/CT imaging between intervention (with amino acid infusion) and control (previous cycle without amino acid infusion) measurements. The primary endpoint will be the difference in renal dosimetry between these paired cycles. Secondary endpoints will include the incidence of renal toxicity and occurrence of TMA, which will be analyzed using appropriate statistical tests based on the data distribution.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/06/2024
Actual
Date of last participant enrolment
Anticipated
6/12/2024
Actual
Date of last data collection
Anticipated
15/06/2025
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 26357 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 42329 0
6150 - Murdoch

Funding & Sponsors
Funding source category [1] 316226 0
Hospital
Name [1] 316226 0
Fiona Stanley Hospital
Country [1] 316226 0
Australia
Primary sponsor type
Hospital
Name
Fiona Stanley Hospital
Address
Country
Australia
Secondary sponsor category [1] 318409 0
Government body
Name [1] 318409 0
Western Australia
Address [1] 318409 0
Country [1] 318409 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315040 0
South Metropolitan Health Service Human Research Ethics Committee
Ethics committee address [1] 315040 0
Ethics committee country [1] 315040 0
Australia
Date submitted for ethics approval [1] 315040 0
22/12/2023
Approval date [1] 315040 0
14/02/2024
Ethics approval number [1] 315040 0

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

Contacts
Principal investigator
Name 133510 0
Dr Zeyad Al-Ogaili
Address 133510 0
Fiona Stanley Hospital, 11 Robin Warren Drive, Murdoch, Western Australia 6150
Country 133510 0
Australia
Phone 133510 0
+61 8 61525067
Fax 133510 0
Email 133510 0
zeyad.al-ogaili@health.wa.gov.au
Contact person for public queries
Name 133511 0
Dr Luis Vitetta
Address 133511 0
Fiona Stanley Hospital. 11 Robin Warren Drive MURDOCH Western Australia 6150
Country 133511 0
Australia
Phone 133511 0
+61 8 61521875
Fax 133511 0
Email 133511 0
luis-vitetta@health.wa.gov.au
Contact person for scientific queries
Name 133512 0
Dr Luis Vitetta
Address 133512 0
Fiona Stanley Hospital. 11 Robin Warren Drive MURDOCH Western Australia 6150
Country 133512 0
Australia
Phone 133512 0
+61 8 61521875
Fax 133512 0
Email 133512 0
luis-vitetta@health.wa.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
The de-identified participant data to be shared includes all individual participant data collected during the trial.
When will data be available (start and end dates)?
Start date: June 2024
End date: May 2025
Available to whom?
Clinical trial consented participants that have adhered to all inclusion and exclusion criteria. This is subject to approval by Principal Investigator Dr Al-Ogaili, Zeyad
EMAIL: Zeyad.Al-Ogaili@health.wa.gov.au
Available for what types of analyses?
1. Renal function tests (e.g., serum creatinine, creatinine clearance) and
2. 3D SPECT/CT imaging for renal dosimetry
How or where can data be obtained?
By email from the principal investigator Dr Al-Ogaili, Zeyad
EMAIL: Zeyad.Al-Ogaili@health.wa.gov.au


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
22073Study protocol  Zeyad.Al-Ogaili@health.wa.gov.au 387613-(Uploaded-03-04-2024-13-34-48)-Study-related document.docx



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.