None listed
Conditions
Brief summary
This study is testing a new gel product called Tutelix™ TL150, which is injected between the prostate and the rectum in men with prostate cancer to act as a physical cushion ("spacer") during radiotherapy. Who is it for? You may be eligible to join this study if you are aged 18 years or above, have histologically confirmed adenocarcinoma of the prostate who is a candidate for external beam radiotherapy and have not had the prostate removed. Study details Participants will be randomly allocated (by chance) to one of two groups to receive either 1) Tutelix spacer and fiducial markers a week before radiotherapy or 2) fiducial marker insertion a week before radiotherapy. Fiducial markers are considered standard of care. Participants will undergo assessments to record medical history and current medications, PSA blood test results and radiotherapy planning MRI and CT scans and questionnaires. During the follow up period all participants will complete questionnaires, have visits with the study doctor to assess any adverse events and the patients who received the Tutelix spacer will also have MRI scans. These visits will occur at the end of radiotherapy treatment, 3 months, 6 months, 12 months and 18 months to determine the radiation dose received during radiotherapy, incidence of adverse events and quality of life. This study will assess the effectiveness and safety of the Tutelix spacer to improve outcomes for patients requiring radiotherapy for prostate cancer.
Interventions
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 transperineal
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.
Sponsors
Tutelix Pty Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Healthy volunteers
No
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.
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.
Outcome results
None listed