Overview

This trial is active, not recruiting.

Condition low or intermediate risk prostate cancer
Treatment advanced imaging for radiotherapy planning and guidance
Sponsor University Health Network, Toronto
Collaborator Princess Margaret Hospital, Canada
Start date September 2006
End date September 2017
Trial size 99 participants
Trial identifier NCT00890006, UHN REB 06-0520-C

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose diagnostic
Arm
(Experimental)
advanced imaging for radiotherapy planning and guidance
Integration of MRI in the treatment planning process / Integration of daily cone-beam computed tomography (CBCT)

Primary Outcomes

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

Secondary Outcomes

Measure
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

Eligibility Criteria

Male participants at least 18 years old.

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.

Additional Information

Official title Low-Intermediate Risk Prostate Cancer: Improving Acute Toxicity Outcomes of Radiotherapy With the Integration of Advanced Imaging for Treatment Planning and Guidance
Principal investigator Peter Chung, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by University Health Network, Toronto.