Low-Intermediate Risk Prostate Cancer: Improving Acute Toxicity Outcomes of Radiotherapy With the Integration of Advanced Imaging for Treatment Planning and Guidance
18 Years
N/A
Male
Low or Intermediate Risk Prostate Cancer
Trial Information
Low-Intermediate Risk Prostate Cancer: Improving Acute Toxicity Outcomes of Radiotherapy With the Integration of Advanced Imaging for Treatment Planning and Guidance
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.
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.
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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.
Outcome Time Frame:
10 years
Safety Issue:
No
Principal Investigator
Cynthia Ménard, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University Health Network, Toronto
Authority:
Canada: Ethics Review Committee
Study ID:
UHN REB 06-0520-C
NCT ID:
NCT00890006
Start Date:
September 2006
Completion Date:
September 2014
Related Keywords:
- Low or Intermediate Risk Prostate Cancer
- Prostate cancer
- Magnetic resonance imaging
- Prostatic Neoplasms
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