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Intensity-Modulated Radiation Therapy in Treating Patients With Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Unknown status
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
hypofractionated radiation therapy
intensity-modulated radiation therapy
Sponsored by
Royal Marsden NHS Foundation Trust
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer, stage IV prostate cancer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Institute of Cancer Research - ChelseaRecruiting
  • Institute of Cancer Research - SuttonRecruiting
  • Royal Marsden - SurreyRecruiting

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
July 24, 2009
Last Updated
August 23, 2013
Sponsor
Royal Marsden NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT00946543
Brief Title
Intensity-Modulated Radiation Therapy in Treating Patients With Prostate Cancer
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2009
Overall Recruitment Status
Unknown status
Study Start Date
March 2000 (undefined)
Primary Completion Date
March 2010 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Royal Marsden NHS Foundation Trust

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer, stage IV prostate cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Enrollment
198 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Radiation
Intervention Name(s)
hypofractionated radiation therapy
Intervention Type
Radiation
Intervention Name(s)
intensity-modulated radiation therapy
Primary Outcome Measure Information:
Title
Late RTOG radiotherapy toxicity as assessed at 6, 12, 18, and 24 months and then annually thereafter
Secondary Outcome Measure Information:
Title
Overall survival
Title
Local control
Title
PSA control
Title
Acute side effects as assessed weekly by the RTOG scoring system
Title
Quality of life
Title
Patterns of recurrence

10. Eligibility

Sex
Male
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David P. Dearnaley, MD, FRCP, FRCR
Organizational Affiliation
Royal Marsden NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Cancer Research - Chelsea
City
London
State/Province
England
ZIP/Postal Code
SW3 6JB
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
44-20-7352-8133
Facility Name
Institute of Cancer Research - Sutton
City
Sutton
State/Province
England
ZIP/Postal Code
SM2 5NG
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
44-181-643-8901
Facility Name
Royal Marsden - Surrey
City
Sutton
State/Province
England
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David P. Dearnaley, MD, FRCP, FRCR
Phone
44-20-8661-3271

12. IPD Sharing Statement

Learn more about this trial

Intensity-Modulated Radiation Therapy in Treating Patients With Prostate Cancer

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