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

Sponsor

University Health Network, Toronto (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT00890006

Collaborator

Princess Margaret Hospital, Canada (Other)

Enrollment

Location

Arm

192

Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Low or Intermediate Risk Prostate Cancer	Procedure: Advanced imaging for radiotherapy planning and guidance	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

99 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Low-Intermediate Risk Prostate Cancer: Improving Acute Toxicity Outcomes of Radiotherapy With the Integration of Advanced Imaging for Treatment Planning and Guidance

Study Start Date :

Sep 1, 2006

Anticipated Primary Completion Date :

Sep 1, 2022

Anticipated Study Completion Date :

Sep 1, 2022

Arms and Interventions

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)

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)

Outcome Measures

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. [10 years]

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. [10 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Health Network	Toronto	Ontario	Canada	M5G 2M9

Sponsors and Collaborators

University Health Network, Toronto
Princess Margaret Hospital, Canada

Investigators

Principal Investigator: Peter Chung, MD, University Health Network, Toronto

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Health Network, Toronto

ClinicalTrials.gov Identifier:

NCT00890006

Other Study ID Numbers:

UHN REB 06-0520-C

First Posted:

Apr 29, 2009

Last Update Posted:

Oct 6, 2021

Last Verified:

Oct 1, 2021

Keywords provided by University Health Network, Toronto

Prostate cancer

Magnetic resonance imaging

Additional relevant MeSH terms:

Prostatic Neoplasms

Study Results

No Results Posted as of Oct 6, 2021