Prostate Cancer
Conditions
Keywords
stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer, stage IV prostate cancer
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.
Interventions
RADIATIONhypofractionated radiation therapy
RADIATIONintensity-modulated radiation therapy
Sponsors
Royal Marsden NHS Foundation Trust
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
MALE
Healthy volunteers
No
Inclusion 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Late RTOG radiotherapy toxicity as assessed at 6, 12, 18, and 24 months and then annually thereafter | — |
Secondary
| Measure | Time frame |
|---|---|
| Local control | — |
| PSA control | — |
| Overall survival | — |
| Quality of life | — |
| Patterns of recurrence | — |
| Acute side effects as assessed weekly by the RTOG scoring system | — |
Countries
United Kingdom
Outcome results
None listed