Rectal spacer for Prostate Cancer Radiotherapy

Suspended

Lead Sponsor: Tata Memorial Centre Department of Atomic Energy Clinical Trial Centre

Brief Summary: Radiotherapy is one of the established treatments for prostate cancer. Modern radiotherapy techniques have been helpful in decreasing dose to adjacent normal structures like bladder and rectum when prostate is being irradiated. However, some significant dose is still received by these organs which can lead to late side effects. Recently, some inert or body similar materials have been used to create space between rectum and prostate and have gained standard of care status through randomized trials for ability to decrease rectal toxicity. These materials are not available off label in India. In this study we are trying to standardize the workflow and testing two of the such materials. One is Hyaluronic acid which is easily available and other is patientâ€™s own blood which can be very cost effective for our patient population. These will help in decreasing the side effects as well as guide more economical solution for Indian patient population.

Recruitment & Eligibility

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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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 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 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).

Locations (1): Tata Memorial Centre
🇮🇳
(Suburban), MAHARASHTRA, India
Tata Memorial Centre
🇮🇳(Suburban), MAHARASHTRA, India
Dr Rahul Krishnatry
Principal investigator
02224177028
krishnatry@gmail.com