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

NCT00890006 · tracked via the Priya Life Science Canada tracker

Sponsor

University Health Network, Toronto

Phase

Not applicable

Started

2006-09

Last updated

2026-06-23

Condition(s) studied

Low or Intermediate Risk Prostate Cancer

Investigational drug(s) / intervention(s)

Advanced imaging for radiotherapy planning and guidance

Advanced imaging for radiotherapy planning and guidance: Integration of MRI in the treatment planning process / Integration of daily cone-beam computed tomography (CBCT)

Study summary

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.

Eligibility

Sex

MALE

Min age

18 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

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. — 10 years

Trial sites (1)

Facility	City	Region	Status
University Health Network	Toronto	Ontario

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT00890006 on ClinicalTrials.gov ↗ ← All trials in Canada