Advanced Imaging for Radiotherapy Treatment Planning and Guidance for Low-Intermediate Risk Prostate Cancer - Full Text View

Sponsored by:	University Health Network, Toronto
Information provided by:	University Health Network, Toronto
ClinicalTrials.gov Identifier:	NCT00890006

Purpose

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.

Condition	Intervention
Low or Intermediate Risk Prostate Cancer	Procedure: Advanced imaging for radiotherapy planning and guidance

MedlinePlus related topics: Cancer MRI Scans Prostate Cancer Radiation Therapy

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Open Label, Single Group Assignment
Official Title:	Low-Intermediate Risk Prostate Cancer: Improving Acute Toxicity Outcomes of Radiotherapy With the Integration of Advanced Imaging for Treatment Planning and Guidance

Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:

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. [ Designated as safety issue: No ]

Secondary Outcome Measures:

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. [ Designated as safety issue: No ]

Estimated Enrollment:	190
Study Start Date:	September 2006
Estimated Study Completion Date:	September 2010
Estimated Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Intervention Details:

Integration of MRI in the treatment planning process / Integration of daily cone-beam computed tomography (CBCT)

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00890006

Contacts

Contact: Cynthia Ménard, MD

416 946-6513

cynthia.menard@rmp.uhn.on.ca

Locations

Canada, Ontario
University Health Network	Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Cynthia Ménard, MD 416 946-6513 cynthia.menard@rmp.uhn.on.ca

Sponsors and Collaborators

University Health Network, Toronto

Investigators

Principal Investigator:

Cynthia Ménard, MD

University Health Network, Toronto

More Information

No publications provided

Responsible Party:	University Health Network, Princess Margaret Hospital ( Dr. Cynthia Ménard, Clinician Scientist, Staff Radiation Oncologist )
Study ID Numbers:	06-0520-C
Study First Received:	April 27, 2009
Last Updated:	April 28, 2009
ClinicalTrials.gov Identifier:	NCT00890006 History of Changes
Health Authority:	Canada: Ethics Review Committee

Keywords provided by University Health Network, Toronto:

Prostate cancer
Magnetic resonance imaging

Study placed in the following topic categories:

Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Prostatic Diseases
Genital Neoplasms, Male

Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009