NCT00921193

Brief Summary

The study aims to evaluate the safety and performance of the RTPS in patients with localized prostate cancer.The RTPS is an investigational device and requires permanent implantation of a small radioactive fiducial, called the Blip, in the prostate.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable prostate-cancer

Timeline
Completed

Started May 2009

Shorter than P25 for not_applicable prostate-cancer

Geographic Reach
2 countries

2 active sites

Status
completed

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

Study Start

First participant enrolled

May 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 15, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 16, 2009

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

March 30, 2011

Status Verified

March 1, 2011

Enrollment Period

1.7 years

First QC Date

June 15, 2009

Last Update Submit

March 29, 2011

Conditions

Prostate Cancer

Keywords

Prostatefiducialsradiation TherapyTrackingLocalization

Outcome Measures

Primary Outcomes (5)

  • Device related adverse events by evaluation of the type, frequency and severity of the device, implantation device and/or implantation procedure related adverse events

    6 months

  • International Prostate Symptom Score (IPSS) questionnaire at baseline, at CT planning and on first week of Radiation Therapy.

    3 weeks

  • Successful implantation of the Blip in the prostate

    1 wk

  • Non migration of the Blip as evaluated by measuring the average absolute change in inter-marker distances measured during and at the end of radiotherapy treatment

    10 weeks

  • Performance of the RTPS in at least five of approximately 40 radiation therapy sessions

    8 weeks

Secondary Outcomes (1)

  • Record target volume movement during at least 5 radiation therapy sessions

    8 weeks

Interventions

Radiation Therapy Positioning System (RTPS)DEVICE

Eligibility Criteria

Age45 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of adenocarcinoma of the prostate.
  • Male, age greater than or equal to 45 years.
  • Intact prostate of at least 30g, as estimated by physical estimation and/or ultrasound.
  • ECOG (Eastern Cooperative Oncology Group) performance status of 0 or 1.
  • Patients must be planned to have external beam radiation as the definitive treatment for their prostate cancer with treatment set-up verification according to a locally fixed protocol.
  • Patients must have anatomy that will allow an adequate pelvic imaging by CBCT as well as CT scanning.
  • Organ confined or locally advanced prostate cancer with clinical N category 0 or x, M category 0 or x.
  • Ability to comply with study visit schedule.
  • Patient (or legal guardian) understands the study requirements and the investigational procedure and provides written Informed Consent before any study-specific tests or procedures are performed.

You may not qualify if:

  • Past history of abdominoperineal (A-P) resection.
  • Planned course of treatment using brachytherapy (permanent brachytherapy seeds or high dose rate \[HDR\] brachytherapy).
  • Allergy to local anesthetics.
  • History of chronic prostatitis.
  • Patients with history of recent acute and/or chronic bleeding disorders.
  • Patients on therapeutic anti-coagulants or anti-platelet therapy, not including aspirin or dipyridamole.
  • Patients for which the maximum body width or the maximum anterior-posterior depth in the abdomino-pelvic region is greater than 40 cm. (Measurements will be made visually with a ruler.)
  • Patients with a body habitus that the CT bore of the CT/LINAC treatment machine cannot accommodate.
  • Patients with a prior history of pelvic or prostate radiotherapy.
  • Patients who have had prior prostate surgery other than a TUR.
  • Cognitively impaired patients who cannot give informed consent.
  • Patients with hip replacement by a metal prosthesis.
  • Patient has participated in, or is planned to participate in, any investigational drug or device study within the past or next 2 months.
  • Patient who has more than 1μCi of any injected or implanted radioactive material within his body.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Leuvens Kankerinstituut

Leuven, B - 3000, Belgium

Location

Dr. Bernard Verbeeten Institute

Tilburg, Netherlands

Location

Related Links

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

  • Philip MP Poortmans, MD, PhD

    Dr. Bernard Verbeeten Instituut

    PRINCIPAL INVESTIGATOR

  • Willy JM de Kruijf, PhD

    Dr. Bernard Verbeeten Instituut

    PRINCIPAL INVESTIGATOR

  • Karin Haustermans, MD

    Leuvens Kankerinstituut

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 15, 2009

First Posted

June 16, 2009

Study Start

May 1, 2009

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

March 30, 2011

Record last verified: 2011-03

Locations

BE(1)NL(1)