TUTELA / TUT-001A
TUTELA / TUT-001A: To evaluate the feasibility of inserting Tutelix™ to reduce the dose of radiation to the rectum in men undergoing radiotherapy
Trial summary:
This study aims to evaluate the feasibility of inserting Tutelix (perirectal spacer) to reduce the dose of radiation to the rectum during radiotherapy for prostate cancer.
Who is it for?
You may be eligible for this study if you are a male with histologically proven low to intermediate risk prostate cancer, life expectancy greater than 10 years, and fit for Tutelix insertion as determined by radiation. For participants in cohort 1, you must be suitable for LDR brachytherapy for cohort 2 you must be suitable for EBRT.
Participants will receive Tutelix solution injected through a fine gauge needle and forms a cohesive hydrogel matrix upon administration. In cohort 1, participants will receive LDR brachytherapy 145Gy with lodine 125 permanent seeds as part of definitive RT for prostate cancer. For Cohort 2, participants will receive 60Gy in 20 fractions as part of definitive RT for prostate cancer.
Post Tutelix insertion participants will be assessed for dose of radiation, dosimetry, toxicity, and product performance.
It is hoped the findings from the study will show the reduction in radiation exposure will decrease bowel-related side effects of gastrointestinal symptoms, as well as an improvement in patients’ bowel-related quality of life.
Receptor status / problem studied:
Inclusion criteria
Cohort 1:
1) Subject must sign an Informed Consent Form (ICF) indicating that he understands the purpose of, and procedures required for the study and is willing to participate for the entire duration.
2) Willing and able to complete all requested study follow up. Patients not suitable for MRI can still be registered on trial (and will not have day 28, 3, 6 and 12 month MRI).
3) Histologically proven low to intermediate risk prostate cancer (ISUP 1-3) suitable for LDR brachytherapy and Tutelix™ insertion as determined by radiation oncologist and proceduralist.
4) Clinical stage T1c-T2N0 or N0M0.
5) Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2.
6) Gleason score < /= 7.
7) Fit for general, spinal or local anaesthetic.
8) Life expectancy > 10 years.
9) PSA < 20ng/mL.
Cohort 2:
1) Subject must sign an Informed Consent Form (ICF) indicating that he understands the purpose of, and procedures required for the study and is willing to participate for the entire duration.
2) Willing and able to complete all requested study follow up. Patients not suitable for MRI can still be registered on trial (and will not have baseline, 3 month, 6 and 12 month MRI).
3) Histologically proven low to intermediate risk prostate cancer (ISUP 1-3) suitable for EBRT and Tutelix™ insertion as determined by radiation oncologist and proceduralist.
4) Clinical stage T1c-T2N0M0.
5) Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2.
6) Gleason score < / =7.
7) Fit for general, spinal or local anaesthetic.
8) Life expectancy > 10 years.
Exclusion criteria
Cohort 1:
1) Metastatic disease including regional nodal metastasis.
2) Patients requiring radiation to pelvis.
3) Patients with poor urinary function (peak urinary flow rate <10 mL/sec or postvoid residual > 100 mL) have a higher risk of post-implant urinary obstruction and require urological assessment prior to considering implant.
4) Obstruction resulting from a large median lobe or high bladder neck may be managed.
5) Non-rheumatoid collagen vascular disorders.
6) Inflammatory bowel disease and/or history of adhesions/bowel obstruction.
7) Previous high dose RT to pelvis defined as any patient receiving more than 30Gy to below bottom of the 5th lumbar vertebrae (L5).
8) Extracapsular extension of prostate cancer.
9) Prostate volume in relation to pubic arch interference.
10) Large TURP defect which precludes seed placement and acceptable dosimetry.
11) Estimated Prostate volume >80cm3.
12) 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.
13) Allergy to anaesthetic or iodine.
14) Known rectal perforation or pre-existing prostatitis.
15) Ongoing inflammation or infection, in or near the intended treatment site.
16) Subjects with known iodine allergies.
Cohort 2:
1) Any patient with high risk prostate cancer (T3a/b or T4, node positive).
2) Planned treatment to the pelvic region.
3) Metastatic disease including regional nodal metastasis.
4) Patients requiring radiation to pelvis.
5) Previous high dose radiation to the pelvis defined as any patient receiving more than 30Gy to below bottom of L5.
6) Poor urinary and bowel function.
7) Radio sensitising medications (e.g. methotrexate).
8) Inflammatory bowel disease and/or history of adhesions/bowel obstruction.
9) Bilateral hip replacement.
10) Cardiac implanted electronic device (CIED) unless radiation dose to CIED approved by treating cardiologist/electrophysiologist.
11) Estimated prostate volume >80cm3.
12) 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.
13) Allergy to anaesthetic.
14) Known rectal perforation or pre-existing prostatitis.
15) Ongoing inflammation or infection, in or near the intended treatment site.
16) Subjects with known iodine allergies.
Trial Title
TUTELA / TUT-001A
Diagnosis
Prostate cancer
Type of trial
Collaborative
Type of treatement
Radiation Oncology
Phase
N/A