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.

Study Overview

• Status: Active, not recruiting
• Conditions: Low or Intermediate Risk Prostate Cancer
• Intervention / Treatment: Procedure: Advanced imaging for radiotherapy planning and guidance

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.

• Study Type: Interventional
• Enrollment (Actual): 99
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 2M9
      • University Health Network

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Time Frame
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.	10 years

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Collaborators: Princess Margaret Hospital, Canada
• Investigators: Principal Investigator: Peter Chung, MD, University Health Network, Toronto

Study record dates

Study Major Dates

• Study Start: September 1, 2006
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: April 27, 2009
• First Submitted That Met QC Criteria: April 28, 2009
• First Posted (Estimated): April 29, 2009

Study Record Updates

• Last Update Posted (Actual): June 23, 2026
• Last Update Submitted That Met QC Criteria: June 19, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Magnetic resonance imaging; Prostate cancer
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms; Health Services; Health Care Facilities Workforce and Services; Community Health Services; Behavioral Disciplines and Activities; Mental Health Services; Counseling
• Other Study ID Numbers: UHN REB 06-0520-C