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CompletedNCT00188786Updated Feb 15, 2011

Cone Beam CT for Daily Image Guidance - Prostate Cancer

A Phase 2 interventional study of daily Cone Beam CT for imaging guidance for radiotherapy in Prostatic Neoplasms, sponsored by University Health Network, Toronto. Completed at 1 site in Canada. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-02-15.

Sponsored by University Health Network, Toronto · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
30
Allocation
Non-randomized
Ages
18 Years and older
Sex
Male
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Study summary

Conformal dose escalated radiation therapy (CRT) is standard treatment for patients with low and intermediate risk prostate cancer. CRT requires accurate daily localization of the prostate prior to treatment to correct for prostate motion and set-up errors. Cone beam computed tomography (CT) can accurately localize fiducial markers within the prostate. Cone Beam CT also provides important information on daily position of organs within the pelvis. This study aims to assess the feasibility of cone beam CT for daily localization of the prostate as well as document changes in size and location of pelvic organs during an entire course of CRT.

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Conditions studied

  • Prostatic Neoplasms

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In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

This study's planned enrollment of 30 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

University Health Network, Toronto is the lead sponsor of 1,411 studies on the registry; 292 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

  • Diagnosis of adenocarcinoma of the prostate
  • Patient undergoing dose escalated conformal external beam radiation therapy
  • Low or intermediate risk prognostic factors (PSA 20 or less, Gleason score \<8, Clinical T category \<T3, Clinical N category 0 or X, M category 0 or X
  • Age 18 years or older
  • ECOG performance status 0 or 1
  • Informed consent

Exclusion criteria

Exclusion Criteria:

  • Inflammatory bowel disease or collagen vascular disease
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Interventions

  • Proceduredaily Cone Beam CT for imaging guidance for radiotherapy
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What researchers measure

Primary outcomes

  1. To evaluate the feasibility of cone beam CT for daily on-line image guidance in patients receiving conformal radiation therapy for prostate cancer.

Secondary outcomes

  1. To measure the amount of interfraction movement of the prostate and seminal vesicles with current bowel regimen of daily milk of magnesia.

  2. To measure the amount of interfraction movement and deformity of the rectum and bladder with current bowel regimen of daily milk of magnesia.

  3. To develop a technique for delivery of radiation therapy that reduces normal tissue toxicity, based on rectal and bladder avoidance models.

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Study locations

1 site
  • Princess Margaret Hospital
    Toronto, Ontario M5G 2M9, Canada
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 15, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00188786
Lead sponsor
University Health Network, Toronto
Collaborators
Princess Margaret Hospital, Canada
First posted
Sep 16, 2005
Start date
Apr 2005
Primary completion
Apr 2010
Completion
Apr 2010
Last update
Feb 15, 2011

Study contacts

Charles Catton, MD
principal investigator · Princess Margaret Hospital, Canada
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2011. You cannot join it, but the record below documents what was studied.

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