Rectal spacer for Prostate Cancer Radiotherapy

Not Applicable

Suspended

• Conditions: Health Condition 1: C61- Malignant neoplasm of prostate

• Registration Number: CTRI/2020/07/026761
• Lead Sponsor: Tata Memorial Centre Department of Atomic Energy Clinical Trial Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 January 2023

Recruitment & Eligibility

• Status: Suspended
• Sex: Not specified
• Target Recruitment: 0

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To develop standard procedures for recto-prostatic spacer during prostate cancer radiotherapy treatment using blood or hyaluronic acid.Timepoint: 2 years