Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001358932
Ethics application status
Approved
Date submitted
9/11/2020
Date registered
17/12/2020
Date last updated
19/10/2024
Date data sharing statement initially provided
17/12/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Emerging digital imaging-guided theranostic therapy for newly diagnosed high risk prostate cancer patients: A feasibility study
Scientific title
Emerging digital prostate specific membrane antigen positron emission tomography/computed tomography (PSMA PET/CT) guided Lutetium-177-PSMA therapy pre- and post-prostatectomy in newly diagnosed high risk prostate cancer patients: A feasibility study
Secondary ID [1] 302738 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 319671 0
Condition category
Condition code
Cancer 317600 317600 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will involve performing Lutetium-177 (177Lu)-prostate-specific membrane antigen (LuPSMA) treatment as an adjunct to standard care (prostatectomy) in patients with newly diagnosed high-risk PSMA-expressing prostate cancer.
LuPSMA is a novel and highly targeted systemic radioligand therapy for progressive metastatic castration-resistant prostate cancer.
Patients will undergo one LuPSMA treatment 8.0–9.0 +/- 10% GBq activity administered
via a dedicated radionuclide therapy pump (RadInject, Tema Sinergie, Italy) over 10 minutes under the supervision of a Nuclear Medicine Radiologist and a Technologist.
This is followed by prostatectomy surgery within 1-2 weeks after LuPSMA treatment.
Patients will undergo a second dose of LuPSMA treatment 8-10 weeks after prostatectomy.
Patients will undergo two, single doses of LuPSMA in total by intravenous infusion.
Intervention code [1] 319018 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 325647 0
Progression-free survival as assessed by recurrence of prostate cancer observed on digital PSMA positron emission tomography/computed tomography.
Timepoint [1] 325647 0
Up to 10 years following first LuPSMA treatment as per routine standard care under the care of their treating specialist.
Primary outcome [2] 325648 0
Progression-free survival as assessed by change in serum prostate specific antigen level.
Timepoint [2] 325648 0
Up to 10 years following first LuPSMA treatment as per routine standard care under the care of their treating specialist.
Primary outcome [3] 325650 0
Overall survival as determined by time lapsed between first LuPSMA treatment and date of death.
Timepoint [3] 325650 0
Up to 10 years following first LuPSMA treatment as per routine standard care under the care of their treating specialist.
Secondary outcome [1] 388672 0
Safety of LuPSMA treatment as assessed by monitoring adverse events as per the Common Terminology Criteria for Adverse Events (CTCAE) v5.
Timepoint [1] 388672 0
During and following LuPSMA treatment for a maximum of 4 weeks post-treatment.

Eligibility
Key inclusion criteria
Newly diagnosed high-risk prostate-specific membrane antigen (PSMA)-expressing prostate cancer defined as International Society of Urological Pathologists grade of 5 or Gleason score of 9 or 10, and a minimum standard uptake value of 10 on digital Gallium-68 (Ga68)-PSMA positron emission tomography/computed tomography (PET/CT).
Patient must be scheduled for a prostatectomy with a Wesley surgeon.

Other inclusion criteria is standard for this treatment at our site.
Inclusive of:
• Referrals for LuPSMA therapy are accepted from Medical Oncologists, Radiation Oncologists or Urologists. On referral, each patient is discussed at a multi-disciplinary team meeting to ensure that there is consensus on the appropriateness of LuPSMA therapy.
• To confirm suitability for treatment, a Ga68-PSMA PET/CT with diagnostic-quality CT demonstrating PSMA-avid disease is required.
• Laboratory tests are required to demonstrate; (i) baseline serum prostate-specific antigen (PSA) level, (ii) a full blood count showing acceptable haemoglobin (at least 90 g/L), neutrophil (at least 1.5 x 10^9/L) and platelet (at least 75 x 10^9/L) values, (iii) renal function without impairment (estimated glomerular filtration rate (eGFR) at least 40 mL/min), and (iv) liver function without impairment (albumin at least 25 g/L). Laboratory test results are used as a guide only, with exceptions made on a case-by-case basis.
• A nuclear medicine renal scan with technetium-99 m mercaptoacetyltriglycine (99mTc-MAG3) is required if there is evidence of renal obstruction or impairment on the diagnostic-CT component of the Ga68-PSMA PET/CT or eGFR test.
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Any disease outside the prostate on digital PSMA PET/CT.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
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
Phase 1 / Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
1/08/2022
Actual
Date of last participant enrolment
Anticipated
1/12/2022
Actual
Date of last data collection
Anticipated
28/06/2030
Actual
Sample size
Target
5
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 17978 0
The Wesley Hospital - Auchenflower
Recruitment postcode(s) [1] 31934 0
4066 - Auchenflower

Funding & Sponsors
Funding source category [1] 307163 0
Commercial sector/Industry
Name [1] 307163 0
I-MED Radiology Network
Country [1] 307163 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
I-MED Radiology Network
Address
Level 1
Wesley Specialist Centre
87 Lang Pde
Auchenflower 4066 QLD
Country
Australia
Secondary sponsor category [1] 307755 0
None
Name [1] 307755 0
Address [1] 307755 0
Country [1] 307755 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307276 0
UnitingCare Human Research Ethics Committee
Ethics committee address [1] 307276 0
Ethics committee country [1] 307276 0
Australia
Date submitted for ethics approval [1] 307276 0
24/08/2020
Approval date [1] 307276 0
20/10/2020
Ethics approval number [1] 307276 0
2011

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

Contacts
Principal investigator
Name 106650 0
Dr David Wong
Address 106650 0
I-MED Radiology
The Wesley Hospital
40 Chasely St
Auchenflower 4066 QLD
Country 106650 0
Australia
Phone 106650 0
+61 07 3371 9588
Fax 106650 0
Email 106650 0
research@i-med.com.au
Contact person for public queries
Name 106651 0
Sepinoud Firouzmand
Address 106651 0
Level 1
Wesley Specialist Centre
87 Lang Pde
Auchenflower 4066 QLD
Country 106651 0
Australia
Phone 106651 0
+61 07 3371 9588
Fax 106651 0
Email 106651 0
research@i-med.com.au
Contact person for scientific queries
Name 106652 0
Sepinoud Firouzmand
Address 106652 0
Level 1
Wesley Specialist Centre
87 Lang Pde
Auchenflower 4066 QLD
Country 106652 0
Australia
Phone 106652 0
+61 07 3371 9588
Fax 106652 0
Email 106652 0
research@i-med.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Participant data will be shared with the respective individuals in the study and publishing/sharing via conference presentations or journal articles is planned to share the cohort data publicly.


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.