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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
17/12/2020
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
Gender
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
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
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] 307161 0
Other Collaborative groups
Name [1] 307161 0
Wesley Medical Research
Address [1] 307161 0
Level 8
The Wesley Hospital
451 Coronation Dr,
Auchenflower QLD 4066
Country [1] 307161 0
Australia
Funding source category [2] 307163 0
Commercial sector/Industry
Name [2] 307163 0
I-MED Radiology Network
Address [2] 307163 0
Level 1
Wesley Specialist Centre
87 Lang Pde
Auchenflower 4066 QLD
Country [2] 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
HREC Coordinator
UnitingCare Health Human Research Ethics Committee
The Wesley Hospital
PO Box 499
Auchenflower Qld 4066
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
This study is investigating the safety, progression-free survival and overall survival of Lutetium-177 (Lu) prostate-specific membrane antigen (PSMA) radioligand therapy for the treatment of newly diagnosed high-risk prostate cancer patients.

Who is it for?
You may be eligible to participate in this study if you are aged 18 years or older, have been recently diagnosed with prostate cancer (localised to the prostate) and are scheduled to be treated with surgery (prostatectomy).

Study details
Participants enrolled in this study will undergo a digital Gallium-68 PSMA positron emission tomography/computed tomography (PET/CT), imaging of the body to ensure cancer is localised to the prostate. Participants will then receive one dose of LuPSMA by intravenous infusion 1-2 weeks prior to scheduled prostatectomy. Then 7-9 weeks following surgery, patients will undergo another LuPSMA treatment.

It is hoped that this research will determine that LuPSMA is safe and effective as an adjunct to surgery in treatment of patients with high-risk prostate cancer and can improve outcomes for future patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 106650 0
Dr Nicholas Brown
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
Dr Rhiannon McBean
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
Dr Rhiannon McBean
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 other documents available
Summary results
No Results