Intensity-Modulated Radiation Therapy in Treating Patients With Prostate Cancer

August 23, 2013 updated by: Royal Marsden NHS Foundation Trust

A Phase I Dose Escalation Study of the Use of Intensity Modulated Radiotherapy (IMRT) to Treat Prostate and Pelvic Nodes in Patients With Prostate Cancer - Pelvic IMRT for Prostate Cancer

RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.

PURPOSE: This phase I trial is studying the best dose of intensity-modulated radiation therapy in treating patients with prostate cancer.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • To test the feasibility of delivering hypofractionated intensity-modulated radiotherapy to the prostate and pelvic nodes of patients with prostate cancer.
  • To determine the optimal dose level of this treatment regimen to be used in future studies.

OUTLINE: Patients are stratified according to small bowel total volume (low small bowel volume < 450 cc vs high small bowel volume ≥ 450 cc).

Patients undergo hypofractionated intensity-modulated radiotherapy to the prostate and pelvis for 4 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 6 months for 5 years and then annually thereafter.

Study Type

Interventional

Enrollment (Anticipated)

198

Phase

  • 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

  • United Kingdom
    • England
      • London, England, United Kingdom, SW3 6JB
        • Recruiting
        • Institute of Cancer Research - Chelsea
        • Contact:
          • Contact Person
          • Phone Number: 44-20-7352-8133
      • Sutton, England, United Kingdom, SM2 5PT
        • Recruiting
        • Royal Marsden - Surrey
        • Contact:
          • David P. Dearnaley, MD, FRCP, FRCR
          • Phone Number: 44-20-8661-3271
      • Sutton, England, United Kingdom, SM2 5NG
        • Recruiting
        • Institute of Cancer Research - Sutton
        • Contact:
          • Contact Person
          • Phone Number: 44-181-643-8901

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

DISEASE CHARACTERISTICS:

  • Diagnosis of prostate cancer meeting 1 of the following criteria:

    • Stage T3b/T4 disease or radiological or pathological pelvic nodal metastases
    • Localized disease (stage pT2-T4) with > 30% estimated risk of pelvic nodal metastases
    • High-risk (Gleason score ≥ 8 or ≥ 2 risk factors) or very high-risk disease according to the National Collaborative Cancer Network (NCCN)
    • Has undergone prostatectomy AND has stage T2-T3a, N0 disease with extensive high-risk disease (Gleason score ≥ 8) or seminal vesicle or lymph node involvement
  • Candidate for radical radiotherapy

PATIENT CHARACTERISTICS:

  • No inflammatory bowel disease or other small bowel disease

PRIOR CONCURRENT THERAPY:

  • No prior pelvic radiotherapy or surgery (excluding prostatectomy)

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Late RTOG radiotherapy toxicity as assessed at 6, 12, 18, and 24 months and then annually thereafter

Secondary Outcome Measures

Outcome Measure
Overall survival
Quality of life
Patterns of recurrence
Local control
PSA control
Acute side effects as assessed weekly by the RTOG scoring system

Collaborators and Investigators

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

Sponsor

Royal Marsden NHS Foundation Trust

Investigators

  • Principal Investigator: David P. Dearnaley, MD, FRCP, FRCR, Royal Marsden NHS Foundation Trust

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, 2000

Primary Completion (Anticipated)

March 1, 2010

Study Registration Dates

First Submitted

July 24, 2009

First Submitted That Met QC Criteria

July 24, 2009

First Posted (Estimate)

July 27, 2009

Study Record Updates

Last Update Posted (Estimate)

August 26, 2013

Last Update Submitted That Met QC Criteria

August 23, 2013

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000601695
  • RMNHS-1766
  • EU-20869

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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