Use of Non-invasive 4D Ultrasound Clarity System in Prostate IMRT/RapidArc Therapy

Prostate Cancer Clinical Trial

Official title:

Evaluation of the Use of Non-invasive 4D Ultrasound Clarity System in Real-time Tracking of the Target Volume in Prostate IMRT/RapidArc Therapy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02408497
• Other study ID #: NCC DRO 4D-us CS
• Status: Active, not recruiting
• Phase: N/A
• First received: March 31, 2015
• Last updated: August 1, 2017
• Start date: April 2015
• Est. completion date: December 2018

Study information

• Verified date: August 2017
• Source: National Cancer Centre, Singapore
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

A single arm phase II study of prostate motion for prostate cancer to primarily compare prostate motion between different treatment duration for IMRT and VMAT.

Description:

Primarily, this is a single arm phase I study of prostate motion for prostate cancer to primarily compare prostate motion between different treatment duration for IMRT and VMAT. The radiation therapy is to be delivered using intensity modulated radiotherapy (IMRT) or Volumetric Modulated Arc therapy (VMAT) with the aid of volumetric image guidance to ensure accuracy and real-time 3D ultrasound images as observational record of the prostate motion. All the recruited patients are prescribed and treated with either VMAT or IMRT treatment. In order to simulate the behaviour of prostate motion in an IMRT scenario, the group of VMAT patients will be required to remain in treatment position for an additional 7 minutes depending on techniques used (once a week).

In order to assess the level of acceptance of the treatment position, responses to the same comfort survey for the current treatment position (i.e. using leg immobiliser) by a cohort of 60 patients treated in another IGRT treatment room will be used as the baseline. In addition, RTT satisfaction questionnaire will also be administered to assess the handling of the new immobilizer.

Acute toxicity will be measured at preset intervals using CTCAE version 3.0 and as will International prostate symptom score (IPSS) questionnaire which focuses on urinary symptoms. Symptoms or toxicities reported from this study is relevant for patients treated with IMRT or VMAT with full bladder protocol.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Patient must be able to provide study-specific informed consent prior to study entry.

Exclusion Criteria:

• Patient who cannot abide to the departmental hydration protocol

• Prostatectomy cases

• Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatment involved in this protocol requires contact of ultrasound probe to the perineum area.

• Patient enrolled in other clinical trials

Related Conditions & MeSH terms

• Prostate Cancer

Locations

Country	Name	City	State
Singapore	National Cancer Centre	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Centre, Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The extent of intra-fraction prostate motion using an ultrasound system during IMRT and during RapidArc therapy		2 years
Secondary	The 3D ultrasound capability of the Clarity® system (from Elekta AB Stockholm, Sweden) in providing real-time information of the prostate movement during the treatment delivery		2 years
Secondary	The efficacy of full bladder protocol for patient undergoing prostate radiotherapy		2 years
Secondary	The rate of acute GI and GU side effects within 3 months (<90 days) after radical radiotherapy		2 years
Secondary	Patient comfort, compliance and tolerance of two setup techniques		2 years