Intensity Modulated Radiation Therapy (IMRT) Pelvic Nodes Prostate

December 5, 2023 updated by: University Health Network, Toronto

A Phase I/II Study of Dose Escalated Intensity Modulated Radiation Therapy (IMRT) for the Treatment of Pelvic Lymph Nodes and Primary Tumour in Patients With Carcinoma of the Prostate

The purpose of this study is to determine the feasibility and late toxicity of dose escalated radiation therapy to the pelvic lymph nodes and prostate and seminal vesicles in the treatment of high risk prostate cancer. All eligible patients with high risk prostate cancer who are going to have primary radiation therapy to the pelvic lymph nodes and prostate seminal vesicles with or without concurrent hormonal therapy will be approached regarding study entry.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Prostate cancer is now the most commonly diagnosed cancer in Canadian men and is the third most common cause of cancer death.1 Locally advanced prostate cancer (clinical T3/T4) is uncommon in North America because of earlier diagnosis following widespread PSA testing and patient information campaigns. However, in the past decade the term high-risk prostate cancer has been developed to include the previous locally advanced disease and patient with T1/T2 disease with poor prognostic features (either a high Prostate Specific Antigen or high Gleason score). The risk of involvement of pelvic lymph nodes by prostate cancer for certain subgroups of intermediate risk and most high risk prostate cancer may be substantial. The long term results of conventional dose (66-70 Gy) external beam radiation therapy for intermediate and locally advanced prostate cancer have been disappointing. The combination of hormonal therapy and radiation therapy or radiation therapy dose escalation are the two strategies which have been evaluated and are now used to improve these results.

Study Type

Interventional

Enrollment (Actual)

81

Phase

  • Phase 2
  • Phase 1

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
      • Toronto, Ontario, Canada, M5G 2M9
        • University Health Network, Princess Margaret Hospital

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

No older than 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • A histologic diagnosis of adenocarcinoma of the prostate within six months of entry.
  • Clinical Stage T1-T2 with (PSA >20 or Gleason score >7)
  • Clinical Stage T3, T4
  • Bone scan reported as negative for metastases within 6 months of study entry.
  • All patients must have a CT scan of the abdomen and pelvis reported as negative for nodal metastases within 12 wks of study entry.
  • The patient must not have received greater than 6 months of hormonal therapy.
  • The patient must not have received cytotoxic anticancer therapy prior to study entry.
  • Patients must have an ECOG performance status of 2 or less.
  • Age 80 years old or less
  • Signed informed consent

Exclusion Criteria:

  • Patients with history of inflammatory bowel disease or other contraindication to radical radiation therapy
  • Patients with prior colorectal surgery
  • Patients with prior or active malignancy except non-melanoma skin carcinoma within 5 years of the diagnosis of 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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IMRT in prostate cancer
Radiation: Dose Escalated IMRT
Patients will receive external beam RT 55.1Gy in 29 once daily fractions to pelvic lymph nodes/prostate/seminal vesicles followed by 24.7Gy in 13 once daily fractions to the prostate/seminal vesicles using intensity modulated radiation therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Determine the feasibility and late toxicity of dose escalated radiation therapy to the pelvic lymph nodes and prostate and seminal vesicles in the treatment of high risk prostate cancer.
Time Frame: after all patients have completed study intervention
after all patients have completed study intervention

Secondary Outcome Measures

Outcome Measure
Time Frame
acute toxicity of therapy;prostate motion when pelvic radiotherapy is delivered;treatment time required to deliver IMRT to the pelvic lymph nodes, prostate and seminal vesicles
Time Frame: after all patients have completed study intervention
after all patients have completed study intervention

Collaborators and Investigators

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

Sponsor

University Health Network, Toronto

Investigators

  • Principal Investigator: Tara Rosewell, MD, University Health Network, Princess Margaret Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

November 1, 2005

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

October 24, 2023

Study Registration Dates

First Submitted

June 2, 2009

First Submitted That Met QC Criteria

June 4, 2009

First Posted (Estimated)

June 5, 2009

Study Record Updates

Last Update Posted (Estimated)

December 6, 2023

Last Update Submitted That Met QC Criteria

December 5, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UHN REB 05-0396-C

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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