NCT00890006Active, not recruiting
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
Source: ClinicalTrials.gov · Last updated 23 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 99 (actual)
- First submitted
- 27 Apr 2009
- Start date
- Sept 2006
- Primary completion date
- Sept 2027
- Lead sponsor
- University Health Network, Toronto
- Diseases
- Prostate cancer
- NCT number
- NCT00890006
What you commit to
- Study type: Interventional
- Participants enrolled: 99
- From Sept 2006 to the primary completion date, Sept 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Severe adverse event with prior TRUS-guided prostate biopsy
Other illness
- History of hip replacement
- Inflammatory bowel disease or collagen vascular disease
- Bleeding diathesis or anticoagulant therapy that cannot safely be ceased temporarily
Other
- Contraindication to fiducial marker placement
- 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.
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Health Network Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.