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Trial registered on ANZCTR


Registration number
ACTRN12618001774213p
Ethics application status
Submitted, not yet approved
Date submitted
13/08/2018
Date registered
29/10/2018
Date last updated
29/10/2018
Date data sharing statement initially provided
29/10/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Focal Laser treatment for localised Prostate Cancer.
Pilot study to evaluate the safety and effectiveness with ProFocal -Rx
Scientific title
Pilot study of ProFocal-RX a novel Focal Laser Therapy device for the treatment of localised prostate cancer.
Secondary ID [1] 295707 0
Nil Known
Universal Trial Number (UTN)
U1111-1218-3766
Trial acronym
FLT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 309099 0
Condition category
Condition code
Cancer 307969 307969 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In this study, we propose to evaluate the feasibility of a novel, thermal therapy and feedback system (ProFocal­Rx Laser Thermal Therapy System) for the treatment of biopsy confirmed and MR­ visible prostate cancers. The system’s real­time measurement system provides information on the thermal dose delivered to the target, resulting in a more precise and controlled delivery which has not been possible to date with other ablative therapies.
MR / ­US guided focal laser ablation will be performed using the ProFocal­-Rx Thermal Therapy System. The treatment require a general anaesthetic and approximate treatment time of under 1 hour. The Urologist will be performing the treatment. This system comprises a surgical diode laser, a fiberoptic laser applicator with diffusing tip and temperature feedback monitoring system.Focal targeted laser therapy for treating localised prostate cancer in men. The actual lasering of the tumour will take 10-20 minutes. Men 50 years and older who have been diagnosed with a positive MRI and intermediate risk prostate cancer will be eligible. They will undergo a general anaesthetic and MRI - US fusion targeted treatment of their prostate cancer in an outpatient setting. Immediate post treatment MRI will determine the extent of the laser ablation and a follow up targeted biopsy of the prostate in 6 weeks will confirm the success of the outcome of focal laser therapy.
Intervention code [1] 302029 0
Treatment: Devices
Comparator / control treatment
No Control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 307070 0
Absence of any residual cancer in the targeted area from laser ablation.
Timepoint [1] 307070 0
MRI following treatment to assess the treatment effect. The MRI allows for immediate treatment effect to be measured after focal laser ablation.
On going assessment of the prostate gland will also be performed with annual MRI scans to assess the whole and treated prostate site.
Secondary outcome [1] 350544 0
Following the focal ablation of the prostate tumour a MRI scan of the prostate will be performed to assess the ablation effect on the tumour site. Also the tumour will be assess by performing a biopsy of the prostate six weeks after the focal therapy was performed. This will be used to assess the absence or presence of tumour.
Timepoint [1] 350544 0
6 weeks post treatment a targeted and template biopsy of the prostate is performed to assess this.
Secondary outcome [2] 352582 0
No de novo cancer in the remainder ( non treated areas ) of the prostate to be evaluated
Timepoint [2] 352582 0
MRI scan immediately post treatment
6 weeks post treatment - prostate biopsy
PSA blood tests and questionnaires at 6 monthly intervals
Prostate MRI scan yearly
This will be done for a total of 5 years

Eligibility
Key inclusion criteria
•Male, 50 years of age or older.
•Diagnosis of prostate adenocarcinoma. ( intermediate risk )
•PSA <20
•Clinical stage T2c or less
•Gleason score of 7 or less.
•One, two, or three tumor suspicious regions identified on multiparametric MRI
•Negative radiographic indication of extra­capsular extent.
•A documented Karnofsky performance status of at least 70.
•Estimated survival of 5 years or greater, as determined by treating physician. •Tolerance for anesthesia/sedation.
•Ability to give informed consent.
Minimum age
50 Years
Maximum age
80 Years
Gender
Males
Can healthy volunteers participate?
No
Key exclusion criteria
•Presence of any condition (e.g., metal implant, shrapnel) not compatible with MRI.
•Severe lower urinary tract symptoms as measured by an International Prostate Symptom Score (IPSS) of 20 or greater.
•History of other significant primary non­skin malignancy within previous three years.
•Patients with renal insufficiency with an estimated glomerular filtration (EGF) < = 30 are excluded, as they will not be able to undergo gadolinium enhance MRI.

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 not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
The profile and the number of projected participants (100) are appropriate to answer the research question of this pilot study. A similar study was recently performed to assess the safety and efficacy of focal laser therapy at Macquarie University Hospital to answer this question.
The recruitment strategy is fair with clear outline of inclusion and exclusion criteria. Patients are fully informed of the procedure before written consent is obtained.

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)
NSW,SA
Recruitment hospital [1] 11639 0
Nepean Hospital - Kingswood
Recruitment hospital [2] 11640 0
Calvary North Adelaide Hospital - North Adelaide
Recruitment hospital [3] 11654 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [4] 11655 0
Nepean Private Hospital - Kingswood
Recruitment postcode(s) [1] 23686 0
2747 - Kingswood
Recruitment postcode(s) [2] 23687 0
5006 - North Adelaide
Recruitment postcode(s) [3] 23701 0
5000 - Adelaide
Recruitment outside Australia
Country [1] 20748 0
Singapore
State/province [1] 20748 0
Country [2] 20749 0
Switzerland
State/province [2] 20749 0
Country [3] 20750 0
Israel
State/province [3] 20750 0

Funding & Sponsors
Funding source category [1] 300297 0
Commercial sector/Industry
Name [1] 300297 0
Medlogical Innovations Pty Ltd
Address [1] 300297 0
PO Box 307, Penrith 2751
NSW / Australia
Country [1] 300297 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Medlogical Innovations Pty Ltd
Address
PO Box 307, Penrith 2751
NSW / Australia
Country
Australia
Secondary sponsor category [1] 300141 0
None
Name [1] 300141 0
Address [1] 300141 0
Country [1] 300141 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 301109 0
Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 301109 0
Nepean Public Hospital
Derby Street, Kingswood 2747
NSW
Ethics committee country [1] 301109 0
Australia
Date submitted for ethics approval [1] 301109 0
19/03/2018
Approval date [1] 301109 0
Ethics approval number [1] 301109 0

Summary
Brief summary
The purpose of this study is to evaluate the feasibility of a new laser therapy system (called ProFocal­-Rx Laser Therapy System) for the treatment of certain prostate cancers.

Who is it for?
You may be eligible for this study if you are aged 50 or older and have a diagnosis of prostate cancer.

Study details
All participants in this study will undergo a general anaesthetic and targeted treatment (called ‘ablation’) of their prostate cancer in an outpatient setting. Immediate following the procedure, an MRI scan will be performed to determine the extent of the laser ablation. Six weeks after the procedure participants will have a targeted biopsy of the prostate to assess the outcome of the laser therapy.

It is hoped this research will demonstrate the feasibility of this technology to treat prostate tumours, reduce discomfort and improve patients quality of life.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 85894 0
A/Prof Celi Varol
Address 85894 0
Medlogical Innovations Pty Lts

PO Box 307,
Kingswood 2747
NSW / Australia
Country 85894 0
Australia
Phone 85894 0
+61 2 47218383
Fax 85894 0
+61 2 47212575
Email 85894 0
celi.varol@medlogicalinnovations.com
Contact person for public queries
Name 85895 0
A/Prof Celi Varol
Address 85895 0
Medlogical Innovations Pty Lts

PO Box 307,
Kingswood 2747
NSW / Australia
Country 85895 0
Australia
Phone 85895 0
+61
Fax 85895 0
+61 2 47212574
Email 85895 0
celi.varol@medlogicalinnovations.com
Contact person for scientific queries
Name 85896 0
A/Prof Celi Varol
Address 85896 0
Medlogical Innovations Pty Lts

PO Box 307,
Kingswood 2747
NSW / Australia
Country 85896 0
Australia
Phone 85896 0
+61 2 47128383
Fax 85896 0
+61 2 47212575
Email 85896 0
celi.varol@medlogicalinnovations.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
All individual data will be de identified and all data will be accumulated and analysed as a whole in the study protocol.
What supporting documents are/will be available?
Study protocol
Informed consent form
Ethical approval
Summary results
No Results