Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000981325
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
20/05/2026
Date registered
Help: Date registered
11/08/2026
Date last updated
Help: Date last updated
11/08/2026
Date data sharing statement initially provided
Help: Data sharing statement date
11/08/2026
Type of registration
Help: Type of registration
Retrospectively registered

Titles & IDs
Public title
Focal therapy using the Pro-Focal laser system for men with prostate cancer recurrence after previous radiotherapy
Scientific title
ProFocal Laser Therapy for Prostate Tissue Ablation in Radiotherapy Recurrent Disease in men
Additional trial identifiers [1] 317346 0
Nil
Universal Trial Number (UTN)
Trial acronym
PROFIRE (PROFOCAL Focal Laser Therapy for Radiorecurrent Disease)
Related trial records

Health condition
Health condition(s) studied:
Prostate Cancer 342008 0
Condition category
Condition code
Cancer 338088 338088 0 0
Prostate
Surgery 339112 339112 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
PROFOCAL Laser focal therapy device will be used to treat prostate cancer lesions within the prostate. Treatment will be delivered by surgeons who have (Therapeutic Goods Administration (TGA) Authorised Prescriber approval to use the device. The treatment is delivered under General Anaesthesia at Nepean Public Hospital in one session typically lasting 90-120 minutes.
Treatment is delivered via a transperineal (percutaneously) approach (with transrectal ultrasound guidance) in a very similar manner to transperineal prostate biopsy.
Post-treatment monitoring includes prostate specific antigen (PSA) blood test at 3 months then 12 months, quality of life questionnaires at 3 and 12 months, and MRI +/- biopsy within the first 12 months.
Intervention code [1] 334138 0
Treatment: Devices
Intervention code [2] 334139 0
Treatment: Surgery
Description of the comparator or control
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 345486 0
Adverse Events
Timepoint [1] 345486 0
30 days, 3 months, 12 months post laser focal therapy
Secondary outcome [1] 461866 0
Cancer ablation
Timepoint [1] 461866 0
One MRI will be obtained approximately 1-3 months post focal laser therapy
Secondary outcome [2] 461867 0
Patient related quality of life outcomes (assessed as composite outcome)
Timepoint [2] 461867 0
3 months and 12 months post focal laser therapy
Secondary outcome [3] 465505 0
Post-treatment prostate biopsy
Timepoint [3] 465505 0
3 months post focal laser therap
Secondary outcome [4] 465506 0
PSA
Timepoint [4] 465506 0
3 months and 12 months post-focal laser therapy

Eligibility
Key inclusion criteria
• Confirmed diagnosis of prostate adenocarcinoma and for whom prostate tissue ablation is clinically warranted (less than 6 months prior to enrolment)
• Radiologically targetable lesion
• Biopsy concordant cancer distribution
• PSA less than or equal to 20ng/mL (performed less than 3 months prior to enrolment)
• Clinical Stage – localised to prostate gland
• Failed primary radiation therapy
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Healthy volunteers
No
Key exclusion criteria
• Known metastatic disease or use of hormone deprivation therapy
• Bleeding disorders
• History of ulcerative colitis or other chronic inflammatory conditions affecting rectum (including fistula and stenosis)
• Active untreated urinary tract infection
• Presence of extra-prostatic spread of the cancer based on CT or PET scan
• Other sever, acute or chronic medical or psychiatric condition or laboratory abnormalities that might increase the risks associated with study participation

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)
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
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
27/07/2026
Date of last participant enrolment
Anticipated
24/11/2027
Actual
Date of last data collection
Anticipated
24/11/2028
Actual
Sample size
Target
40
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 321918 0
Hospital
Name [1] 321918 0
Nepean Hospital
Country [1] 321918 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Medlogical Innovations
Address
Country
Australia
Secondary sponsor category [1] 324783 0
None
Name [1] 324783 0
Address [1] 324783 0
Country [1] 324783 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 320454 0
Nepean Blue Mountains Local Health District
Ethics committee address [1] 320454 0
Ethics committee country [1] 320454 0
Australia
Date submitted for ethics approval [1] 320454 0
24/09/2025
Approval date [1] 320454 0
01/02/2026
Ethics approval number [1] 320454 0
2025/ETH00371

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

Contacts
Principal investigator
Name 150534 0
Dr Isaac Thangasamy
Address 150534 0
Total Care Urology - Suite 203, 13 Barber Avenue, Kingswood NSW 2747
Country 150534 0
Australia
Phone 150534 0
+61 400994387
Fax 150534 0
Email 150534 0
[email protected]
Contact person for public queries
Name 150535 0
Isaac Thangasamy
Address 150535 0
Total Care Urology - Suite 203, 13 Barber Avenue, Kingswood NSW 2747
Country 150535 0
Australia
Phone 150535 0
+61 400994387
Fax 150535 0
Email 150535 0
[email protected]
Contact person for scientific queries
Name 150536 0
Isaac Thangasamy
Address 150536 0
Total Care Urology - Suite 203, 13 Barber Avenue, Kingswood NSW 2747
Country 150536 0
Australia
Phone 150536 0
+61 400994387
Fax 150536 0
Email 150536 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.