3D-Conformal Radiation vs Helical Tomotherapy in Prostate Cancer

April 15, 2020 updated by: Ottawa Hospital Research Institute

Randomized Phase III Trial of 3D Conformal Radiotherapy Versus Helical Tomotherapy IMRT in High-Risk Prostate Cancer

In this study we are comparing two forms of radiotherapy. This study is being done because it is not clear at present time whether intensity modulated radiotherapy (IMRT) can reduce side effects of radiotherapy compared to standard radiotherapy (called 3D-Conformal Radiotherapy).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Radical radiation therapy plays an important role in the management of prostate cancer, yielding comparable long-term outcomes to surgery. Unfortunately, long term disease free survival data using PSA criteria have shown that less than 50% of high-risk patients are free of disease at 10 years. To improve on the results of conventional dose radiotherapy dose escalation with three-dimensional conformal radiation has been employed. Due to the irregular shape of the prostate and the variable motion of this organ there is substantial radiation of adjacent normal surrounding tissue during treatment which results in radiation-induced toxicity. Intensity-modulated radiation therapy (IMRT) is a new form of radiation therapy. Preliminary evidence suggests that IMRT improves the dose distribution during radiation therapy of the prostate. The hypothesis of this study is that IMRT delivered using Helical Tomotherapy can reduce late toxicity of radical radiotherapy as compared to three-dimensional conformal radiation (3DCRT) in high-risk prostate cancer patients.

Study Type

Interventional

Enrollment (Anticipated)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
        • The Ottawa Hospital Regional Cancer Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  1. A pathologic diagnosis of adenocarcinoma of the prostate
  2. Age greater than 18 years
  3. ECOG performance status of 2 or less.

  4. Presence of any of the following high risk features:

    • Clinical stage cT3-4 or
    • Gleason score 8-10 or
    • Pre-treatment PSA > 20ng/ml or
    • Clinical N1/N2 or pathologic N1/N2

Exclusion Criteria:

  1. Patients with contraindication to radical radiation therapy including inflammatory bowel disease
  2. Prior or active malignancy except non-melanoma skin carcinoma within 5 years of the diagnosis of prostate cancer
  3. Prior pelvic radiotherapy for other malignancies
  4. Prior cytotoxic chemotherapy
  5. Prior orchiectomy, radical prostatectomy, cryotherapy or thermal ablation therapy for prostate cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Arm A: 3D-Conformal Radiation

Intervention: Standard radiation treatment for high risk prostate cancer. Once daily Monday to Friday for 8 weeks.

3DCRT 7800 cGY/39 Fractions/ STD Technique*

  • Initial 4F 3DCRT to Nodes/ Prostate + Seminal Vesicles 4,600 cGy/23
  • Boost 6 F 3DCRT to Prostate 3,200 cGy/16
Other: Arm A: 3D-Conformal Radiation

3DCRT 7800 cGY/39 Fractions/ STD Technique* once daily Monday to Friday for 8 weeks

  • Initial 4F 3DCRT to Nodes/ Prostate + Seminal Vesicles 4,600 cGy/23
  • Boost 6 F 3DCRT to Prostate 3,200 cGy/16
Other Names:
  • Radiation Therapy
Experimental: Arm B: Helical Tomotherapy Intensity Modulated Radiotherapy

Intervention: Helical Tomotherapy Intensity Modulated Radiotherapy (IMRT) once daily Monday to Friday for 8 weeks.

IMRT using Helical Tomotherapy* 7800 cGY/39 Fractions Boost IMRT to Prostate 3,200 cGy/16
Radiation: Arm B: Helical Tomotherapy Intensity Modulated Radiotherapy

IMRT using Helical Tomotherapy* 7800 cGY/39 Fractions once daily Monday to Friday for 8 weeks

  • Initial IMRT to Nodes/Prostate + Seminal Vesicles 4,600 cGy/23
  • Boost IMRT to Prostate 3,200 cGy/16
Other Names:
  • IMRT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Late rectal toxicity from radiotherapy of the prostate
Time Frame: Month 1, 4, 8, every 4 months during year 1-2, then every 6 months during years 2-5, then every 12 months until disease progression
Outcome measurements will be determined by physical exam and bloodwork.
Month 1, 4, 8, every 4 months during year 1-2, then every 6 months during years 2-5, then every 12 months until disease progression

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute rectal toxicity, Acute and late bladder toxicity, Disease specific survival at 5 years, Biochemical relapse free survival at 5 years, Local control rates at 5 years, Quality of Life
Time Frame: Month 1, 4, 8, every 4 months during year 1-2, then every 6 months during years 2-5, then every 12 months until disease progression
Outcome measurements will be determined by physical exam and bloodwork.
Month 1, 4, 8, every 4 months during year 1-2, then every 6 months during years 2-5, then every 12 months until disease progression

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ottawa Hospital Research Institute

Investigators

  • Study Director: Shawn Malone, MD, Ottawa Hospital Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2005

Primary Completion (Actual)

January 1, 2015

Study Completion (Anticipated)

June 30, 2020

Study Registration Dates

First Submitted

May 15, 2006

First Submitted That Met QC Criteria

May 15, 2006

First Posted (Estimate)

May 17, 2006

Study Record Updates

Last Update Posted (Actual)

April 17, 2020

Last Update Submitted That Met QC Criteria

April 15, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2005242-01H
  • OTT 05-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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