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

NCT ID: NCT02408497

Last Updated: 2017-08-02

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2018-12-31

Brief 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.

Detailed 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.

Conditions

Prostate Cancer

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Centre, Singapore

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeffrey Kit Long Tuan, Dr

Role: PRINCIPAL_INVESTIGATOR

National Cancer Centre, Singapore

Locations

National Cancer Centre

Singapore, , Singapore

Countries

Singapore

Other Identifiers

NCC DRO 4D-us CS

Identifier Type: -

Identifier Source: org_study_id