Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001030763
Ethics application status
Approved
Date submitted
4/07/2022
Date registered
22/07/2022
Date last updated
22/07/2022
Date data sharing statement initially provided
22/07/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
The accuracy of 99mTc-PSMA imaging in the re-staging and response monitoring in patients with metastatic prostate cancer
Scientific title
A prospective, open-label, single center, single arm study of 99mTc- Hynic PSMA (TLX 599) SPECT/CT in disease staging and response monitoring in patients with progressive PSMA-positive metastatic prostate cancer
Secondary ID [1] 307489 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic prostate cancer 326895 0
Condition category
Condition code
Cancer 324097 324097 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Concurrent 99mTc-HYNIC-PSMA-SPECT/CT and PSMA-PET baseline studies will be performed. Follow up studies will be performed at the time of standard of care restaging or whenever deemed necessary by the investigator. Standard clinical monitoring will continue during the study, as per the supervising medical oncologist direction. Routine tests would include PSA level at baseline and follow up visit at 12-14 weeks post study enrolment. Results obtained from both radiologic assessments would be compared for concordance and overall accuracy in determining treatment response. This will be compared against the overall clinical impression by the treating clinician based on all available data (including serum PSA).

This is a pilot, single arm, comparative trial. Twenty men with prostate carcinoma who will be referred to our center for PSMA imaging will be included in the study. The indications for imaging will be recurrence evaluation or restaging.

All patients will be fully informed about the procedures and probable use of data for research project and will sign a written consent. The study will be approved by local ethics committee. All patients will undergo 18F-DCFPyL PET/CT and 99mTc-HYNIC-PSMA SPECT/CT scans in a reasonably short time interval (< 1 week, whenever possible).

In the day of the SPECT/CT scan a single administration of 740 +/- 111 MBq 99mTc(CO3)-HYNIC-PSMA will be given intravenously. Introduction of radiotracer may be followed by IV saline to flush the line and ensure complete dose is administered to patient. Three to four hours post-injection a SPECT/CT scan of the chest, abdomen and pelvis will be acquired. In the day of the PET/CT scan participants will be injected intravenously with 18F-DCFPyL and a scan will be perfomed 120-min following uptake period.

Images will be reviewed separately and anonymously by two experienced nuclear physicians and will be categorized as normal or abnormal. Any non-physiologic uptake will be considered as abnormal finding. Any suspicious finding will be further evaluated by delayed imaging and post void images. In case of discrepancy between readers, consensus will be obtained by consulting with a third expert. Furthermore, the locations of abnormal uptake will be fully described in both sets of images with special attention on prostate bed, local or regional lymph nodes and skeletal system. Patients will remain in the trial from the time of the baseline 18F-DCFPyL PET/CT and 99mTc-HYNIC-PSMA SPECT/CT scans and until the time of restaging after 12-14 weeks from baseline

Response assessment of 99mTc-HYNIC-PSMA SPECT/CT will be compared to F18-DCFPyL PET/CT, PSA levels and clinical assessment

Clinical assessment, if appropriate, will be undertaken at baseline and over the entire study period as per standard of care follow-up by treating physicians. This will include checking for any signs of allergic reaction in addition to basic vital signs (blood pressure, heart rate, respiratory rate and temperature). Physical examinations may include the examination of the following: general appearance, eyes, ears, nose, throat, chest/cardiovascular/respiratory, gastrointestinal, musculoskeletal, thyroid/neck, lymph nodes, and neurological

The trial investigators will permit trial-related monitoring, audits, and regulatory inspections, providing direct access to source data/documents. This may include, but not limited to, Human Research Ethics Committees and Institutional Governance Review Bodies.

External monitoring will not be planned. However, the researchers will assess the data quality after 2 months from study start, to ensure that any major deficiencies are identified early in the study and rectified so as not to compromise the outcome of the study.

The trial will be conducted in compliance with the protocol, Good Clinical Practice and regulatory requirements.
Intervention code [1] 323946 0
Diagnosis / Prognosis
Comparator / control treatment
Concordance of 99mTc-HYNIC-PSMA SPECT/CT and of 18F-DCFPyL PET/CT scans will be assessed.

18F-DCFPyL PET/CT scan is considered the reference comparator
Control group
Active

Outcomes
Primary outcome [1] 331899 0
To assess the imaging concordance of 99mTc-HYNIC-PSMA SPECT/CT with 18F-DCFPyL PET/CT assessments in metastatic prostate cancer.

Qualitative Image Analysis Images will be interpreted by experienced nuclear medicine physicians for both 18F-DCFPyL PET/CT and 99mTc-HYNIC-PSMA SPECT/CT scans. Physicians will complete a qualitative interpretation case report form recording the number of positive lesions (0, 1, 2, 3, 4, 5, 6–10, or .10) and the site of recurrence (local, regional nodes, distant nodes, bone, liver, lung, or other). Regional nodes will be considered pelvic, hypogastric, obturator, iliac (internal or external), or sacral; other nodal locations will be considered distant. Physicians will have access to all clinical data; they will record scans as positive or negative and rate their confidence in the diagnosis for a total of 6 possible qualitative results (negative: high, moderate, or low; positive: high, moderate, or low).

Timepoint [1] 331899 0
Baseline and a single time point 12-14 weeks post commencement depending on clinician and scan availability
Secondary outcome [1] 411550 0
• Response assessment of 99mTc-HYNIC-PSMA SPECT/CT as compared to PSA levels and clinical assessment

Imaging response assessment will be determined qualitatively (visual assessment) by the experienced nuclear medicine specialist readers
Timepoint [1] 411550 0
Baseline and a single time point 12-14 weeks post commencement depending on clinician and scan availability
Secondary outcome [2] 412090 0
• Imaging characteristics of 99mTc-HYNIC-PSMA SPECT/CT compared to 18F-DCFPyL PET/CT or Ga – PSMA – 11 PET/CT (intensity of the lesions)

Qualitative Image Analysis Images will be interpreted by experienced nuclear medicine physicians for both 18F-DCFPyL PET/CT and 99mTc-HYNIC-PSMA SPECT/CT scans. Physicians will complete a qualitative interpretation case report form recording the number of positive lesions (0, 1, 2, 3, 4, 5, 6–10, or .10) and the site of recurrence (local, regional nodes, distant nodes, bone, liver, lung, or other). Regional nodes will be considered pelvic, hypogastric, obturator, iliac (internal or external), or sacral; other nodal locations will be considered distant. Physicians will have access to all clinical data; they will record scans as positive or negative and rate their confidence in the diagnosis for a total of 6 possible qualitative results (negative: high, moderate, or low; positive: high, moderate, or low).
Timepoint [2] 412090 0
Baseline and a single time point 12-14 weeks post commencement depending on clinician and scan availability
Secondary outcome [3] 412091 0
• Any adverse events (AEs) of 99mTc-HYNIC-PSMA and 18F-DCFPyL administration

Safety monitoring and reporting will be conducted according to NHMRC Guidance.

Common adverse events that can occur at site of injection are bleeding, bruising, swelling, and redness at the injection site, itching and infection (This is very uncommon). Some claustrophobic patients may feel uncomfortable and may require minor sedatives.

AEs following 99mTc-HYNIC-PSMA SPECT/CT and of 18F-DCFPyL PET/CT assessments must be recorded. Hypersensitivity reactions to 99mTc-Hynic PSMA or 18F-DCFPyL injections will be promptly managed, as per department policies, and the scan might need to be interrupted. The Investigator will probe, via discussion with the subject, for the occurrence of AEs and record the information in the site’s source documents. Adverse events will be described by duration (start and stop dates and times), severity, outcome, treatment and relation to the radiotracers injection and/or to the SPECT/CT or PET/CT will be assessed.

All AEs following 99mTc-HYNIC-PSMA SPECT/CT and of 18F-DCFPyL PET/CT assessments must be recorded.
Timepoint [3] 412091 0
Baseline and a single time point 12-14 weeks post commencement depending on clinician and scan availability

Eligibility
Key inclusion criteria
1. Male patients aged> 18 yrs
2. History of histologically confirmed prostate cancer
3. Metastatic patients who are considered for treatment with 177 Lu – PSMA
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
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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
5/09/2022
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 22693 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 37971 0
6150 - Murdoch

Funding & Sponsors
Funding source category [1] 311769 0
Hospital
Name [1] 311769 0
Fiona Stanley Hospital
Country [1] 311769 0
Australia
Primary sponsor type
Hospital
Name
Fiona Stanley Hospital
Address
11 Robin Warren Dr, Murdoch WA 6150
Country
Australia
Secondary sponsor category [1] 313230 0
None
Name [1] 313230 0
Address [1] 313230 0
Country [1] 313230 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311211 0
South Metropolitan Health Service Human Research Ethics Committee (SMHS HREC)
Ethics committee address [1] 311211 0
Ethics committee country [1] 311211 0
Australia
Date submitted for ethics approval [1] 311211 0
Approval date [1] 311211 0
08/06/2022
Ethics approval number [1] 311211 0

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

Contacts
Principal investigator
Name 120342 0
Dr Zeyad Al-Ogaili
Address 120342 0
Fiona Stanley Hospital
Molecular Imaging and Radionuclide Therapy Service
11 Robin Warren Dr, Murdoch WA 6150
Country 120342 0
Australia
Phone 120342 0
+61 08 6152 2222
Fax 120342 0
Email 120342 0
zeyad.al-ogaili@health.wa.gov.au
Contact person for public queries
Name 120343 0
Zeyad Al-Ogaili
Address 120343 0
Fiona Stanley Hospital
Molecular Imaging and Radionuclide Therapy Service
11 Robin Warren Dr, Murdoch WA 6150
Country 120343 0
Australia
Phone 120343 0
+61 08 6152 2222
Fax 120343 0
Email 120343 0
zeyad.al-ogaili@health.wa.gov.au
Contact person for scientific queries
Name 120344 0
Zeyad Al-Ogaili
Address 120344 0
Fiona Stanley Hospital
Molecular Imaging and Radionuclide Therapy Service
11 Robin Warren Dr, Murdoch WA 6150
Country 120344 0
Australia
Phone 120344 0
+61 08 6152 2222
Fax 120344 0
Email 120344 0
zeyad.al-ogaili@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?
All de-identified individual line-by-line data
When will data be available (start and end dates)?
Immediately following publication, no end date determined
Available to whom?
Researchers who provide a sound proposal
Available for what types of analyses?
IPD meta-analyses
How or where can data be obtained?
Contact PI via email zeyad.al-ogaili@health.wa.gov.au


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
16528Study protocol  zeyad.al-ogaili@health.wa.gov.au
16529Informed consent form  zeyad.al-ogaili@health.wa.gov.au



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.