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A Prospective Quantification of Patient-Reported Adverse Events Following Trans-Rectal Ultrasound-Guided Intra-Prostatic Marker Insertion


N/A
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

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Trial Information

A Prospective Quantification of Patient-Reported Adverse Events Following Trans-Rectal Ultrasound-Guided Intra-Prostatic Marker Insertion


Precise localisation of target organs has become increasingly important with the routine use
of steep dose gradients from conformal and intensity modulated radiotherapy. This is
particularly challenging when soft tissue target organs, such as the prostate, displace
relative to bony anatomy. Although novel imaging techniques are being developed for the
direct visualisation of such soft tissue structures, contrast and image quality is currently
limited. However, the use of radio-opaque intra-prostatic fiducial markers(IPM) during high
dose radiotherapy has proven very effective in terms of improving accuracy, and decreasing
toxicity.


Inclusion Criteria:



- Have biopsy confirmed prostate cancer (any risk category)

- Have 3 intra-prostatic markers inserted at PMH prior to radiotherapy

- Be willing to provide written informed consent

- Be willing to complete the adverse event questionnaires

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Quantify adverse events reported by prostate patients following trans-rectal ultrasound-guided implantation of intra-prostatic markers for RT

Outcome Time Frame:

1.5 years

Safety Issue:

No

Principal Investigator

Tara Rosewall

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Health Network, Princess Margaret Hospital

Authority:

Canada: Ethics Review Committee

Study ID:

UHN REB 08-0136-CE

NCT ID:

NCT00923416

Start Date:

September 2008

Completion Date:

November 2010

Related Keywords:

  • Prostate Cancer
  • Intra-Prostate Markers
  • Transrectal Ultrasound
  • Prostate Cancer Patients
  • Prostatic Neoplasms

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