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NCT Number: NCT00188799

Xray Volume Imaging (Cone Beam CT) - Prostate Cancer

Conformal dose escalated radiotherapy was adopted as the standard treatment technique at PMH for intermediate risk patients with localised disease in 1997. This technique provides a much smaller margin of error for treatment set-up and delivery than with conventional techniques. One way to ensure the accuracy of treatment delivery is to image the prostate position daily, prior to therapy, to allow for appropriate set-up corrections. To do so, imaging markers are implanted into the prostate under guided ultrasound (a standard procedure at PMH). However, there are disadvantages in using imaging markers which include added time to the treatment planning process, and an invasive procedure with a potential for discomfort, bleeding and infection. This study will investigate and compare X-ray volume imaging to the gold standard imaging markers.

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Key information

Conditions

Prostatic Neoplasms Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of adenocarcinoma of the prostate
  • Patient undergoing escalated dose conformal external beam radiotherapy.
  • Patient has low or intermediate risk prognostic factors: all of PSA <21, Gleason score <8, clinical T category <T3, clinical N category 0 or X, M category 0 or X.
  • Informed consent

Exclusion criteria

  • No diagnosis of adenocarcinoma of the prostate
  • Patient not undergoing escalated dose conformal radiotherapy
  • Patient does not have low or intermediate risk prognostic factors

Treatment and study plan

daily Xray volume imaging for planning radiotherapy

Procedure

Primary outcomes

  1. To evaluate he feasibility of daily X-ray volume imaging during conformal radiotherapy.

Secondary outcomes

  1. To provide preliminary data concerning the relative utility of daily X-ray volume image matching compared to fiducial marker image matching.

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Collaborators

  • Canadian Association of Radiation Oncology
  • Princess Margaret Hospital, Canada

Registry information

Official study title

A Clinical Study of X-ray Volume Imaging to Evaluate the Daily Set-up Accuracy of Conformal Prostate Radiotherapy

Important dates

Study start
2003
Study completion
2004
First posted
Sep 16, 2005
Registry last updated
Jul 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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