None listed
Conditions
Brief summary
The purpose of this study is to assess the efficacy of the use of TraceIT for radiotherapy in prostate cancer when compared to SpaceOAR. Who is it for? You may be eligible for this study if you are an adult who has been diagnosed with prostate cancer and is scheduled for primary curative prostate cancer radiotherapy. Study details All participants who are undergoing radiation therapy with the insertion of TraceIT as part of standard care. Using an MRI scan, we will follow up on the reabsorption of the TraceIT hydrogel over the 12 month period. This is in addition to the standard of care treatment. Participants will also be asked to complete questionnaires to assess quality of life and overall experiences. This study will assess the efficacy of the TraceIT product and further support and validate its use in our clinical practice.
Interventions
Patients who are eligible for this trial will consent to Radiation Therapy and the insertion of TraceIT hydrogel injection.
This appointment will involve both the Radiation Oncologist and the Urologist. A probe will be placed in your rectum and a numbing solution will be injected in the region between the anus and the genitals (known as the “perineum”). 10mL of the TraceIT® gel material will be introduced into the perineum using a long fine needle. The needle placement and injection will be guid
Patients who are eligible for this trial will consent to Radiation Therapy and the insertion of TraceIT hydrogel injection. This appointment will involve both the Radiation Oncologist and the Urologist. A probe will be placed in your rectum and a numbing solution will be injected in the region between the anus and the genitals (known as the “perineum”). 10mL of the TraceIT® gel material will be introduced into the perineum using a long fine needle. The needle placement and injection will be guided by use of sound waves from the rectal probe, which is used to create a picture of the pelvic organs as the needle is advanced and the spacer material is deposited between the prostate and the rectum. Following injection, the needle and probe will be removed An MRI and planning CT is performed 3-5 days post procedure. Treatment planning and radiotherapy are delivered per departmental standards and include image guidance during radiation therapy, weekly review during treatment and regular follow-up post treatment. The resorption of the gel will be assessed using MRI scans at the planning stage, 3 and 12 months post treatment.
Sponsors
Genesis Cancer Care
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients with stage cT1-2N0M0 prostate cancer scheduled for primary curative prostate cancer radiotherapy 2. Able to provide written consent
Exclusion criteria
1. Women 2. Patient ineligible or unwilling to consent to radiation therapy to the prostate 3. Patients ineligible or unwilling to consent to the insertion of a Spacer, specifically TraceIT® a. Patients allergic to iodine or shellfish
Outcome results
None listed