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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001131347
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
3/08/2026
Date registered
Help: Date registered
11/09/2026
Date last updated
Help: Date last updated
11/09/2026
Date data sharing statement initially provided
Help: Data sharing statement date
11/09/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
TUT-CIP-002: A Pivotal, Multicenter, Open-label, Randomized Controlled Trial to Evaluate the Effectiveness and Safety of Tutelix™ TL150 (IOP40), a Thermoresponsive Hydrogel Spacer for Prostate Radiotherapy
Scientific title
TUT-CIP-002: A Pivotal, Multicenter, Open-label, Randomized Controlled Trial to Evaluate the Effectiveness and Safety of Tutelix™ TL150 (IOP40), a Thermoresponsive Hydrogel Spacer for Prostate Radiotherapy
Additional trial identifiers [1] 318076 0
Nil
Universal Trial Number (UTN)
Trial acronym
TUT-CIP-002
Related trial records

Health condition
Health condition(s) studied:
Prostate Cancer 343098 0
Condition category
Condition code
Cancer 339187 339187 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Tutelix™ is a water-based solution of a proprietary synthetic polymer with rheological characteristics similar to water. It is radiologically opaque, ensuring safe, simple, and effective administration.
Tutelix™ is intended to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer and, in creating this space, it is the intent to reduce the radiation dose delivered to the anterior rectum.
The Tutelix™ injection will be performed transperineally by a credentialed proceduralist using a fine-gauge needle, and the solution will polymerize into a cohesive gel within approximately 1 to 2 minutes upon contact with body temperature. A credential proceduralist is either a Urologist or Radiation Oncologist who is experienced in placement of fiducials and spacing devices and has been assessed and approved by the trial sponsor to complete this procedure. Approximately 15 to 20 mL of spacer material will be injected (exact volume per clinician discretion based on participant anatomy) to achieve a target separation of about 0.7 to 1.5 cm between the prostate capsule and anterior rectal wall. The procedure will take approximately 20-30 minutes and will be completed under an anaesthetic.
Approximately 7 days following the Index procedure, participants will commence standard of care Radiotherapy (RT) course which may include:
External Beam Radiotherapy (EBRT) - Conventional fractionation, e.g. ~78-82 Gy in 39-42 fractions over ~8 weeks OR Moderately hypofractionated RT, e.g. 60-70 Gy in 20-28 fractions over 4-5 weeks.
Stereotactic Body Radiotherapy (SBRT): 36 - 40 Gy in 5 fractions over 1-2 weeks.
Tutelix™ will be predominantly resorbed within 12 months post-insertion.
Intervention code [1] 334957 0
Treatment: Devices
Intervention code [2] 335022 0
Treatment: Other
Description of the comparator or control
Eligible participants randomized to the control arm (n= ~75) will undergo a fiducial marker insertion procedure approximately 7 days prior to the commencement of standard of care RT . During this procedure, placement of intraprostatic fiducial markers will be performed, unless contraindicated, to enable the same level of position verification as the Tutelix™ group. The procedure will be done under appropriate anesthesia (general, local, or conscious sedation per operator preference) and the procedure will take approximately 15-20 mins.
Approximately 7 days following the Index procedure, participants will commence standard of care RT course which may include:
EBRT - Conventional fractionation, e.g. ~78-82 Gy in 39-42 fractions over ~8 weeks OR Moderately hypofractionated RT, e.g. 60-70 Gy in 20-28 fractions over 4-5 weeks.
SBRT: 36 - 40 Gy in 5 fractions over 1-2 weeks.
Control group
Active

Outcomes
Primary outcome [1] 346433 0
To demonstrate any change to the radiation dose to the rectum by the insertion of the Tutelix™ spacer between the prostate and rectum.
Timepoint [1] 346433 0
End of Radiotherapy course which is completed 2-9 weeks following the index procedure (either insertion of fiducials or insertion of fiducials and Tutelix.
Secondary outcome [1] 465827 0
To assess doses of radiation received by the Clinical target volume (CTV) and Planning target volume (PTV) of the rectum in participants with and without insertion of the Tutelix™ spacer by assessment of the difference in coverage of CTV and PTV between RT planning #1 (planning before the index procedure) and RT planning #2 (planning after the index procedure) for the interventional group. The CTV and PTV of the rectum will be assessed as a composite outcome.
Timepoint [1] 465827 0
End of Radiotherapy course which is completed 2-9 weeks following the index procedure (either insertion of fiducials or insertion of fiducials and Tutelix)
Secondary outcome [2] 465828 0
Proportion of participants with Grade greater than or equal to 2 rectal toxicities following completion of radiotherapy.
Timepoint [2] 465828 0
This will be assessed from the time of insertion of fiducials or fiducials and Tutelix at the end of radiation treatment, 3 months, 6 months, 12 months and 18 months after the insertion.
Secondary outcome [3] 465829 0
The maximum gap distance (mm) between the posterior surface of the prostate and the anterior rectal wall following Tutelix™ placement, assessed on imaging during the radiotherapy course.
Timepoint [3] 465829 0
End of Radiotherapy course which is completed 2-9 weeks following the index procedure (either insertion of fiducials or insertion of fiducials and Tutelix)
Secondary outcome [4] 465830 0
Tutelix™ volume following insertion
Timepoint [4] 465830 0
End of Index procedure
Secondary outcome [5] 465831 0
Change from baseline in EPIC-26 SF Quality of Life
Timepoint [5] 465831 0
Baseline, end of treatment,3,6,12 (and 18 months if applicable).
Secondary outcome [6] 466567 0
To assess doses of radiation received by comparing the CTV and PTV the bladder in participants with and without insertion of the Tutelix™ spacer. The CTV and PTV of the bladder will be assessed as a composite outcome.
Timepoint [6] 466567 0
End of Radiotherapy course which is completed 2-9 weeks following the index procedure (either insertion of fiducials or insertion of fiducials and Tutelix)
Secondary outcome [7] 466574 0
To assess doses of radiation received by comparing the CTV and PTV the penile bulb in participants with and without insertion of the Tutelix™ spacer. The CTV and PTV of the penile bulb will be assessed as a composite outcome.
Timepoint [7] 466574 0
End of Radiotherapy course which is completed 2-9 weeks following the index procedure (either insertion of fiducials or insertion of fiducials and Tutelix)
Secondary outcome [8] 467041 0
The mean gap distance (mm) between the posterior surface of the prostate and the anterior rectal wall following Tutelix™ placement, assessed on imaging during the radiotherapy course.
Timepoint [8] 467041 0
End of Radiotherapy course which is completed 2-9 weeks following the index procedure (either insertion of fiducials or insertion of fiducials and Tutelix)

Eligibility
Key inclusion criteria
Histologically confirmed adenocarcinoma of the prostate who is a candidate for external beam RT (including intensity-modulated or image-guided RT) and Tutelix™ insertion, as determined by radiation oncologist and proceduralist.
Meets one of the following disease risk categories if they are planned for definitive treatment of the primary tumor (e.g. as part of a multimodal therapy approach):
a. Localised prostate cancer: N0, M0;
b. Low-volume mCSPC, e.g. less than or equal to 4 bone metastases with none outside the vertebral column or pelvis, and no visceral metastasis.
Participants must have an intact prostate (no prior prostatectomy) and baseline MRI demonstrating a clean tissue plane between prostate and rectum (no tumor invasion of rectal wall).
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2 at Screening.
Life expectancy greater than 5 years.
In the opinion of the proceduralist, the participant must be fit for anesthesia (general, local, or conscious sedation, per operator preference) and the Index procedure.
Has prostate gland volume acceptable for safe spacer placement, e.g. prostate volume greater than or equal to 80 cc.
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Healthy volunteers
No
Key exclusion criteria
Has posterior extracapsular extension as determined by MRI (at any timepoint).
Participants not suitable for MRI (due to pacemakers, severe claustrophobia, metallic implants, inability to access).
Has metastatic disease classified as high volume.
Has metastatic disease with castrate resistance.
Has received previous high dose radiation to the pelvis, defined as more than 30 Gy to below bottom of L5.
Has inadequate urinary and bowel function for study treatment, in the opinion of the investigator.
Has inflammatory bowel disease and/or history of adhesions or bowel obstruction and/or history of rectal adhesions.
Has known rectal perforation.
Has ongoing inflammation or infection in or near the intended treatment site.
Has a cardiac implanted electronic device (CIED), unless radiation dose to the CIED is approved by the treating cardiologist/electrophysiologist.
Has a known or suspected allergy to anesthetic required for procedure.
Has a known or suspected allergy to any of the components of Tutelix™ including iohexol/iodine allergy.
Has a known or suspected bleeding disorder or concomitant medication that increases risk of bleeding that cannot safely be withheld for surgery, in the opinion of the investigator and proceduralist.
History of transurethral prostate surgery (e.g., Transurethral Needle Ablation (TUNA), Transurethral Microwave Therapy (TUMT), Transurethral Resection of the Prostate [TURP]) if performed within 1 year prior to screening.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomization will be performed according to a randomization schedule and the Randomization Plan. Randomisation list(s) will be created electronically using the statistical analysis software package SAS, with the randomization list(s) exported in .xlsx, .csv and .sas7bdat formats for dissemination to the required recipients and upload to the EDC platform.
Treatment allocations will be open-label; there will be no blinding for this study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A randomisation block design will be implemented with a block size of 3 (within each stratification group combination) with Tutelix TL150 (IOP40)-to-Control ratio of 2:1 for each block.
Randomization will be stratified by clinical staging (grouped as either localized prostate cancer or low volume metastatic disease) and RT schedule (grouped as either EBRT [conventional fractionation or moderately hypofractionated] or SBRT).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
In the randomized portion, approximately 225 participants will be enrolled into the study, with approximately 150 participants randomized to the Tutelix™ arm and approximately 75 participants randomized to the control arm. This sample size yields robust overall study statistical power (>90%) to detect a significant difference in the primary effectiveness endpoint and demonstrate non-inferiority for the key safety endpoint accounting for 10% loss to follow-up. The 2:1 (Tutelix™: control) randomization enriches data on the Tutelix™ arm (useful for safety exposure and subgroup analyses) while maintaining a sufficient control group for comparison, consistent with predicate devices.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
14/09/2026
Actual
Date of last participant enrolment
Anticipated
1/06/2028
Actual
Date of last data collection
Anticipated
31/12/2029
Actual
Sample size
Target
225
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA,VIC
Recruitment hospital [1] 29939 0
GenesisCare - Ringwood - Ringwood East
Recruitment hospital [2] 29940 0
GenesisCare - St Leonards - St Leonards
Recruitment hospital [3] 29941 0
GenesisCare - Bundaberg - Bundaberg West
Recruitment hospital [4] 29942 0
GenesisCare - Hurstville - Hurstville
Recruitment hospital [5] 29943 0
Icon Cancer Centre Gold Coast University Hospital - Southport
Recruitment hospital [6] 29944 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 46302 0
3135 - Ringwood East
Recruitment postcode(s) [2] 46303 0
2065 - St Leonards
Recruitment postcode(s) [3] 46304 0
4670 - Bundaberg West
Recruitment postcode(s) [4] 46305 0
2220 - Hurstville
Recruitment postcode(s) [5] 46306 0
4215 - Southport
Recruitment postcode(s) [6] 46307 0
3000 - Melbourne
Recruitment outside Australia
Country [1] 28400 0
United States of America
State/province [1] 28400 0

Funding & Sponsors
Funding source category [1] 322631 0
Commercial sector/Industry
Name [1] 322631 0
Tutelix Pty Ltd
Country [1] 322631 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Tutelix Pty Ltd
Address
Country
Australia
Secondary sponsor category [1] 325563 0
None
Name [1] 325563 0
Address [1] 325563 0
Country [1] 325563 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 321090 0
St Vincent's Hospital Melbourne Human Research Ethics Committee
Ethics committee address [1] 321090 0
Ethics committee country [1] 321090 0
Australia
Date submitted for ethics approval [1] 321090 0
15/12/2025
Approval date [1] 321090 0
03/06/2026
Ethics approval number [1] 321090 0

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

Contacts
Principal investigator
Name 152626 0
Dr Andrew Oar
Address 152626 0
ICON Gold Coast University Hospital, Block C, Lower Ground, 1 Hospital Blvd, Southport QLD 4215
Country 152626 0
Australia
Phone 152626 0
+61 439 094 448
Fax 152626 0
Email 152626 0
[email protected]
Contact person for public queries
Name 152627 0
Vicki Sproule
Address 152627 0
Tutelix Pty Ltd Unit 29, 34-36 Ralph Street, Alexandria, NSW 2015
Country 152627 0
Australia
Phone 152627 0
+61 400 480 315
Fax 152627 0
Email 152627 0
[email protected]
Contact person for scientific queries
Name 152628 0
Vicki Sproule
Address 152628 0
Tutelix Pty Ltd, Unit 29, 34-36 Ralph Street, Alexandria, NSW 2015
Country 152628 0
Australia
Phone 152628 0
+61 400 480 315
Fax 152628 0
Email 152628 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.