Intensity-Modulated Radiation Therapy in Treating Patients With Prostate Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00946543
First received: July 24, 2009
Last updated: August 23, 2013
Last verified: July 2009
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Radiation: hypofractionated radiation therapy
Radiation: intensity-modulated radiation therapy
Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Late RTOG radiotherapy toxicity as assessed at 6, 12, 18, and 24 months and then annually thereafter [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Overall survival [ Designated as safety issue: No ]
  • Local control [ Designated as safety issue: No ]
  • PSA control [ Designated as safety issue: No ]
  • Acute side effects as assessed weekly by the RTOG scoring system [ Designated as safety issue: Yes ]
  • Quality of life [ Designated as safety issue: No ]
  • Patterns of recurrence [ Designated as safety issue: No ]

Estimated Enrollment: 198
Study Start Date: March 2000
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
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.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00946543

Locations
United Kingdom
Institute of Cancer Research - Chelsea Recruiting
London, England, United Kingdom, SW3 6JB
Contact: Contact Person    44-20-7352-8133      
Institute of Cancer Research - Sutton Recruiting
Sutton, England, United Kingdom, SM2 5NG
Contact: Contact Person    44-181-643-8901      
Royal Marsden - Surrey Recruiting
Sutton, England, United Kingdom, SM2 5PT
Contact: David P. Dearnaley, MD, FRCP, FRCR    44-20-8661-3271      
Sponsors and Collaborators
Royal Marsden NHS Foundation Trust
Investigators
Principal Investigator: David P. Dearnaley, MD, FRCP, FRCR Royal Marsden NHS Foundation Trust
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00946543     History of Changes
Other Study ID Numbers: CDR0000601695, RMNHS-1766, EU-20869
Study First Received: July 24, 2009
Last Updated: August 23, 2013
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
stage IIB prostate cancer
stage IIA prostate cancer
stage III prostate cancer
stage IV prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on July 28, 2014