Clinical trial NCT00946543: 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
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Prostate Cancer
Keywords: stage IIB prostate cancer
stage IIA prostate cancer
stage III prostate cancer
stage IV prostate cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2009-07-27
Enrollment: 198
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Late RTOG radiotherapy toxicity as assessed at 6, 12, 18, and 24 months and then annually thereafter
Secondary outcomes:
measure: Overall survival
measure: Local control
measure: PSA control
measure: Acute side effects as assessed weekly by the RTOG scoring system
measure: Quality of life
measure: Patterns of recurrence
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Institute of Cancer Research - Chelsea
state: England
city: Sutton
country: United Kingdom
facility: Institute of Cancer Research - Sutton
state: England
city: Sutton
country: United Kingdom
facility: Royal Marsden - Surrey
state: England
Study officials:
affiliation: Royal Marsden NHS Foundation Trust
name: David P. Dearnaley, MD, FRCP, FRCR
role: PRINCIPAL_INVESTIGATOR
References: