Phase III Trial of Neutron + Photon Radiation Versus Photon + Hypofractionated Intensity Modulated Radiation Therapy in Localized Prostate Cancer
N/A
N/A
Male
Prostate Cancer
Trial Information
Phase III Trial of Neutron + Photon Radiation Versus Photon + Hypofractionated Intensity Modulated Radiation Therapy in Localized Prostate Cancer
OBJECTIVES:
- Compare the efficacy of neutron and photon radiotherapy vs hypofractionated intensity
modulated radiation, in terms of a lower frequency of chronic complication rate
(chronic toxicity and disease-free survival), in patients with favorable to
intermediate prognosis, stage I-III adenocarcinoma of the prostate.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to stage
of disease (T1 vs T2 vs T3). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo neutron radiotherapy over 15-45 minutes 5 days a week for 2
weeks followed by photon radiotherapy over 15-45 minutes 5 days a week for 5 weeks.
- Arm II: Patients undergo photon radiotherapy over 15-45 minutes 5 days a week for 5
weeks followed by hypofractionated photon irradiation over 15-45 minutes 5 days a week
for 2 weeks.
After completion of study treatment, patients are followed periodically for 5 years and then
yearly thereafter.
PROJECTED ACCRUAL: A total of 300 patients (150 per treatment arm) will be accrued for this
study.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the prostate
- Stage I-III disease (T1-T3, N0, M0)
- No clinical or radiographic evidence of metastasis
- If prostate-specific antigen (PSA) ≥ 10.0 ng/mL and Gleason score is 7, a
radioisotope bone scan must show no evidence of metastasis
- No evidence of lymphatic or visceral metastases of the abdomen or pelvis on
CT scan or MRI
- PSA ≤ 20 ng/mL
- Gleason score ≤ 7 (if stage T3 , score must be < 7)
PATIENT CHARACTERISTICS:
Performance status
- Not specified
Life expectancy
- More than 10 years
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- Not specified
Other
- No other malignancy within the past 5 years except basal cell or squamous cell skin
cancer
PRIOR CONCURRENT THERAPY:
Endocrine therapy
- Prior hormonal therapy allowed provided it was initiated no more than 2 months ago,
and may include the following:
- Luteinizing hormone-releasing hormone agonists (e.g., goserelin, leuprolide)
- Anti-androgens (e.g., flutamide, bicalutamide)
Radiotherapy
- No prior pelvic irradiation
Surgery
- No prior radical prostatectomy
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Outcome Measure:
Occurrence of chronic grade 2 or higher toxicity as measured by RTOG/EORTC late morbidity scoring scheme at 1, 4, 8, and 12 months after treatment, then every 6 months for 5 years, then annually
Safety Issue:
Yes
Principal Investigator
Jeffrey D. Forman, MD, FACR
Investigator Role:
Study Chair
Investigator Affiliation:
Weisberg Cancer Treatment Center
Authority:
United States: Federal Government
Study ID:
CDR0000447161
NCT ID:
NCT00258466
Start Date:
May 2005
Completion Date:
November 2006
Related Keywords:
- Prostate Cancer
- adenocarcinoma of the prostate
- stage I prostate cancer
- stage II prostate cancer
- stage III prostate cancer
- Prostatic Neoplasms
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