Intensity-Modulated Radiation Therapy in Treating Patients With Prostate Cancer

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00946543
• Other study ID #: CDR0000601695
• Secondary ID: RMNHS-1766EU-208
• Status: Recruiting
• Phase: Phase 1
• First received: July 24, 2009
• Last updated: August 23, 2013
• Start date: March 2000

Study information

• Verified date: July 2009
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 198
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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 Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Radiation:
• hypofractionated radiation therapy

• intensity-modulated radiation therapy

Locations

Country	Name	City	State
United Kingdom	Institute of Cancer Research - Chelsea	London	England
United Kingdom	Institute of Cancer Research - Sutton	Sutton	England
United Kingdom	Royal Marsden - Surrey	Sutton	England

Sponsors (1)

Lead Sponsor	Collaborator
Royal Marsden NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Late RTOG radiotherapy toxicity as assessed at 6, 12, 18, and 24 months and then annually thereafter			Yes
Secondary	Overall survival			No
Secondary	Local control			No
Secondary	PSA control			No
Secondary	Acute side effects as assessed weekly by the RTOG scoring system			Yes
Secondary	Quality of life			No
Secondary	Patterns of recurrence			No