NCT02408497

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 31, 2015

Completed
1 day until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 3, 2015

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

August 2, 2017

Status Verified

August 1, 2017

Enrollment Period

3.7 years

First QC Date

March 31, 2015

Last Update Submit

August 1, 2017

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

  • The extent of intra-fraction prostate motion using an ultrasound system during IMRT and during RapidArc therapy

    2 years

Secondary Outcomes (4)

  • 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

  • The efficacy of full bladder protocol for patient undergoing prostate radiotherapy

    2 years

  • The rate of acute GI and GU side effects within 3 months (<90 days) after radical radiotherapy

    2 years

  • Patient comfort, compliance and tolerance of two setup techniques

    2 years

Eligibility Criteria

Age21 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cancer Centre

Singapore, 169610, Singapore

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Jeffrey Kit Long Tuan, Dr

    National Cancer Centre, Singapore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2015

First Posted

April 3, 2015

Study Start

April 1, 2015

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

August 2, 2017

Record last verified: 2017-08

Locations

SG(1)