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: June 2, 2014
Last verified: June 2014

April 27, 2009
June 2, 2014
September 2006
September 2014   (final data collection date for primary outcome measure)
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 ]
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. [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00890006 on ClinicalTrials.gov Archive Site
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 ]
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. [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Advanced Imaging for Radiotherapy Treatment Planning and Guidance for Low-Intermediate Risk Prostate Cancer (Margin)
Low-Intermediate Risk Prostate Cancer: Improving Acute Toxicity Outcomes of Radiotherapy With the Integration of Advanced Imaging for Treatment Planning and Guidance

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.

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.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Low or Intermediate Risk 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)
Experimental: MRI + CBCT in prostate cancer
Intervention: Procedure: Advanced imaging for radiotherapy planning and guidance
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
99
September 2014
September 2014   (final data collection date for primary outcome measure)

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.
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00890006
UHN REB 06-0520-C
Yes
University Health Network, Toronto
University Health Network, Toronto
Princess Margaret Hospital, Canada
Principal Investigator: Cynthia Ménard, MD University Health Network, Toronto
University Health Network, Toronto
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP