TUTELA: Evaluating whether a gel inserted prior to radiation therapy for prostate cancer effectively reduces the radiation to the rectum to reduce unwanted side effects and improve quality of lifeA Prospective, First-In-Human, Single Arm Study to Evaluate the SafeTy, Dosimetry, and Clinical Effects of a Perirectal Thermoresponsive Spacer Device in Patients Undergoing CuraTive Intent ProstatE Modulated Radiotherapy

Exclusion

Subjects who meet the exclusion criteria are not eligible for the Insertion of the IP:
1. Any patient with high-risk prostate cancer (T3a/b or T4, Gleason Score 8 or above, PSA greater than 20.)
2. Metastatic disease including regional nodal metastasis
3. Patients requiring radiation to pelvis
4. Previous high dose radiation to the pelvis defined as any patient receiving more than 30Gy to below bottom of L5.
5. Inadequate urinary and bowel function for trial treatment.
6. Radio sensitising medications (e.g. methotrexate) excluding medications involved in hormonal manipulation as part of treatment for prostate cancer.
7. Inflammatory bowel disease and/or history of adhesions/bowel obstruction.
8. Bilateral hip replacement.
9. Cardiac implanted electronic device (CIED) unless radiation dose to CIED approved by treating cardiologist/electrophysiologist
10. Estimated prostate volume >80cm3
11. Androgen deprivation therapy unless started or investigator intends to start less than 45 days prior to Injection and will continue for a total planned duration of 3-6 months.
12. Allergy to anaesthetic.
13. Known rectal perforation or pre-existing active prostatitis.
14. Ongoing inflammation or infection, in or near the intended treatment site.
15. Any patient with known bleeding disorder or concomitant medication that increases risk of bleeding that cannot safely be withheld for surgery, as deemed by investigator and proceduralist.
16. Subjects with known iodine allergies.