Xray Volume Imaging (Cone Beam CT) - Prostate Cancer

NCT00188799 | Completed Phase 2

• 2 other identifiers: UHN REB 03-0483-CEAbbott-CARO Uro-OncologicAward
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostatic Neoplasms

Outcome Measures

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.

Interventions

daily Xray volume imaging for planning radiotherapy PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Princess Margaret Hospital, Canada: collaborator
• Canadian Association of Radiation Oncology: collaborator

Study Sites (1)

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Charles Catton, MD

  Princess Margaret Hospital, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 16, 2005
• Study Start: November 1, 2003
• Study Completion: November 1, 2004
• Last Updated: July 16, 2015

Record last verified: 2015-07

Locations

CA (1)