Health Condition 1: C61- Malignant neoplasm of prostate
Conditions
Interventions
Intervention1: insertion of rectal seperator for prostate radiotherapy: Either blood or hyaluronic acid will be inserted as spacer under local anaesthesia prior to ratiotherapy for prostate cancer pat
Sponsors
Tata Memorial Centre Department of Atomic Energy Clinical Trial Centre
Eligibility
Inclusion criteria
Inclusion criteria: 1.Age above 18 years 2.Histologically proven adenocarcinoma prostate 3.Any patient suitable and considered for local radical radiotherapy treatment for prostate cancer. 4.No prior pelvic radiotherapy or proctocolitis or inflammatory bowel disease. 5.No contra-indication for prostate radiotherapy. 6.Informed Consent signed for the procedure. 7.Participant in any other clinical trial is not an exclusion criterion.
Exclusion criteria
Exclusion criteria: 1.Unreliable to follow up or poor logistic or social support 2.Involvement of rectal wall on diagnostic MRI scan (standard investigation). 3.Allergic to lignocaine or other local anaesthetic agents. 4.Too anxious to undergo the procedure under local anaesthesia. 5.No bleeding disorder and normal INR, platelet counts, Clotting time, bleeding time 6.Patients on any blood thinners/anticoagulation therapy for systemic conditions which alters platelet count/PTT/INR beyond normal range. 7.MRI is contraindicated for any reason. 8.Not willing to participate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To develop standard procedures for recto-prostatic spacer during prostate cancer radiotherapy treatment using blood or hyaluronic acid.Timepoint: 2 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Functional success in creating 5 â?? 10 mm space between rectal wall and prostate (at mid gland level) To assess procedure related Adverse Events (AEs) To study the impact on dose to the rectum with and without recto-prostatic spacer (blood or hyaluronic acid) when planning radical radiotherapy for prostate cancer. Timepoint: 2 years;To evaluate the impact of recto-prostatic spacer on doses to the target coverage and other organs at risk like bladder, femoral heads and bowel. Stability of space created and identification of space, during the course of radiotherapy. To assess early (at radiotherapy conclusion and 3 months) and late rectal toxicity (at 6, 12, 18 and 24 months) as per Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Timepoint: 2 years;To see if CT and CBCT is as good as MRI to identify volume and dimensions of recto-prostatic space created using blood or hyaluronic acid. Cost analysis for using two types of spacers (blood and hyaluronic acid). Timepoint: 2 years | — |
Countries
India
Contacts
Public ContactDrRahul Krishnatry
Tata Memorial Hospital
Outcome results
None listed