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Advanced Imaging for Radiotherapy Treatment Planning and Guidance for Low-Intermediate Risk Prostate Cancer (Margin)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Princess Margaret Hospital, Canada
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00890006
First received: April 27, 2009
Last updated: May 28, 2013
Last verified: May 2013
History of Changes
  Purpose

The integration of magnetic resonance imaging (MRI) in the treatment planning process for prostate cancer will reduce uncertainties in delineation of the prostate gland, and will enable delineation of the urethra, penile bulb, and internal pudendal artery. The integration of daily cone-beam computed tomography (CBCT) will markedly reduce set-up uncertainties, thereby reducing the minimum planning target volume (PTV) margin. By combining MRI simulation and daily CBCT, and by adapting radiation delivery accordingly, the investigators will reduce dose delivered to the rectum, bladder, urethra, and erectile structures. In this study, the investigators seek to determine whether this dose reduction translates to improved patient outcomes. In a prospective, 2-stage design, up to 190 patients will be enrolled. In the first stage, advanced imaging will be integrated without altering dose planning techniques. Stage 2 will reduce dose delivered to normal tissues, and will collect toxicity outcome measures. This clinical trial will be conducted over 3 years.


Condition Intervention
Low or Intermediate Risk Prostate Cancer
 Procedure: Advanced imaging for radiotherapy planning and guidance

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Low-Intermediate Risk Prostate Cancer: Improving Acute Toxicity Outcomes of Radiotherapy With the Integration of Advanced Imaging for Treatment Planning and Guidance

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • To determine whether reducing the dose to normal tissues, enabled by the integration of advanced imaging, reduces the incidence of RTOG/CTC Grade ≥ 2 toxicity. [ Time Frame: 10 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine whether reducing the dose to normal tissues, enabled by the integration of advanced imaging, improves quality of life in patients receiving external beam radiotherapy. [ Time Frame: 10 years ] [ Designated as safety issue: No ]

Enrollment: 99
Study Start Date: September 2006
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MRI + CBCT in prostate cancer Procedure: Advanced imaging for radiotherapy planning and guidance
Integration of MRI in the treatment planning process / Integration of daily cone-beam computed tomography (CBCT)

Detailed Description:

Advances in medical imaging, and their integration in the treatment planning and daily guidance of radiotherapy, stand to improve the therapeutic ratio. Improved imaging can reduce uncertainties by 1) improving the accuracy and reproducibility of organ or tumor delineation, and 2) guiding and adapting delivery to account for organ motion. This paradigm has been widely accepted in the radiotherapy community, and much research has addressed the technical and dosimetric aspects for a sound clinical implementation. However, direct evidence of a clinical translation to improved patient outcomes is limited. In this study, we hypothesize that the integration of advanced imaging for treatment planning and guidance will safely enable a reduction of dose delivered to normal tissues, and will improve toxicity and quality of life (QOL) outcomes in patients receiving external beam radiotherapy for low or intermediate risk prostate cancer.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Low or intermediate risk localized prostate cancer:

  • Gleason score ≤ 7
  • PSA <20
  • Stage T2a or less (Stage 2 only)
  • <50% of biopsy cores involved with tumor (Stage 2 only)

Exclusion Criteria:

  • History of hip replacement
  • Inflammatory bowel disease or collagen vascular disease
  • Contraindication to fiducial marker placement
  • Bleeding diathesis or anticoagulant therapy that cannot safely be ceased temporarily
  • Severe adverse event with prior TRUS-guided prostate biopsy
  • Patient refuses fiducial marker placement
  • Contraindication to MRI
  • Patient randomization in PROFIT Trial (Stage 2 only)
  • Patients not prescribed 78Gy in 39 fractions to the prostate gland.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00890006

Locations
Canada, Ontario
University Health Network
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University Health Network, Toronto
Princess Margaret Hospital, Canada
Investigators
Principal Investigator: Cynthia Ménard, MD University Health Network, Toronto
  More Information

No publications provided

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT00890006     History of Changes
Other Study ID Numbers: UHN REB 06-0520-C
Study First Received: April 27, 2009
Last Updated: May 28, 2013
Health Authority: Canada: Ethics Review Committee
Canada: Health Canada

Keywords provided by University Health Network, Toronto:
Prostate cancer
Magnetic resonance imaging

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on June 17, 2013