Clinical trial NCT02408497: Use of Non-invasive 4D Ultrasound Clarity System in Prostate IMRT/RapidArc Therapy
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prostate Cancer
Lead sponsor: National Cancer Centre, Singapore
Sponsor class: OTHER
First posted: 2015-04-03
Enrollment: 60
Sex: MALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Prostate cancer patients who are going to receive IMRT/RapidArc therapy at site and are not participating any other clinical studies.

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.

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

Primary outcomes:
measure: The extent of intra-fraction prostate motion using an ultrasound system during IMRT and during RapidArc therapy
timeFrame: 2 years
Secondary outcomes:
measure: 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
timeFrame: 2 years
measure: The efficacy of full bladder protocol for patient undergoing prostate radiotherapy
timeFrame: 2 years
measure: The rate of acute GI and GU side effects within 3 months (<90 days) after radical radiotherapy
timeFrame: 2 years
measure: Patient comfort, compliance and tolerance of two setup techniques
timeFrame: 2 years
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National Cancer Centre
Study officials:
affiliation: National Cancer Centre, Singapore
name: Jeffrey Kit Long Tuan, Dr
role: PRINCIPAL_INVESTIGATOR
References: