NCT00890006

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
99

participants targeted

Target at P50-P75 for not_applicable

Timeline
11mo left

Started Sep 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress96%
Sep 2006Sep 2027

Study Start

First participant enrolled

September 1, 2006

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

April 27, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 29, 2009

Completed
18.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

June 23, 2026

Status Verified

June 1, 2026

Enrollment Period

21 years

First QC Date

April 27, 2009

Last Update Submit

June 19, 2026

Conditions

Low or Intermediate Risk Prostate Cancer

Keywords

Prostate cancerMagnetic resonance imaging

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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

Study Arms (1)

MRI + CBCT in prostate cancer

EXPERIMENTAL
Procedure: Advanced imaging for radiotherapy planning and guidance

Interventions

Advanced imaging for radiotherapy planning and guidancePROCEDURE

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

MRI + CBCT in prostate cancer

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Health Network

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Counseling

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Peter Chung, MD

    University Health Network, Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2009

First Posted

April 29, 2009

Study Start

September 1, 2006

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

June 23, 2026

Record last verified: 2026-06

Locations

CA(1)