Phase III Randomized Study of Radiotherapy to the Prostate With or Without Radiotherapy to the Pelvis in Patients With Stage I, II, or III Adenocarcinoma of the Prostate
N/A
75 Years
Male
Prostate Cancer
Trial Information
Phase III Randomized Study of Radiotherapy to the Prostate With or Without Radiotherapy to the Pelvis in Patients With Stage I, II, or III Adenocarcinoma of the Prostate
OBJECTIVES:
- Compare the survival without recurrence and overall survival of patients with stage I,
II, or III adenocarcinoma of the prostate after receiving radiotherapy to the prostate
with or without radiotherapy to the pelvis.
- Compare the toxic effects of these two regimens in these patients.
- Compare the quality of life of patients treated with these regimens.
- Determine the prognostic factors of progression in these patients.
- Analyze the site of relapse (prostate, pelvic lymph nodes, metastases) in case of
progression in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified by participating
center and prognostic group (poor vs good prognosis).
Patients are randomized to one of two treatment arms.
- Arm I: Patients receive pelvic irradiation plus local prostate irradiation.
- Arm II: Patients receive local prostate irradiation only. Radiotherapy in both arms is
administered 5 days a week for 7 weeks.
Quality of life is assessed before therapy, 12 months after therapy, and then annually
thereafter.
Patients are followed at 2 and 6 months and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 450 patients will be accrued for this study within 4 years.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically proven adenocarcinoma of the prostate
- Stage I (T1b or T1c, N0, M0)
- Stage II (T2, N0, M0)
- Stage III (T3, N0, M0)
- Poor prognosis (high risk of lymph node invasion) defined as meeting at least 1 of
the following criteria:
- Gleason score at least 7
- Prostate-specific antigen (PSA) at least 3 times upper limit of normal (ULN)
- T3 OR
- Good prognosis defined as meeting 1 of the following criteria:
- T1b or T2
- T1c with Gleason score less than 7 and PSA less than 3 times ULN
- No metastases by bone scans or chest x-ray
PATIENT CHARACTERISTICS:
Age:
- 75 and under
Performance status:
- Karnofsky 70-100%
Life expectancy:
- More than 10 years
Hematopoietic:
- Not specified
Hepatic:
- Not specified
Renal:
- Not specified
Other:
- No other malignancy within the past 10 years except basal cell skin cancer
- No adenopathies
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- Not specified
Endocrine therapy:
- At least 2-6 months since prior hormonal therapy, if duration no greater than 4-8
months
- No concurrent luteinizing hormone-releasing hormone agonists
- No concurrent anti-androgen therapy
- No concurrent hormonal therapy in high-risk group
Radiotherapy:
- No prior pelvic radiotherapy
Surgery:
- No prior lymphadenectomy
- No prior surgical castration
- No prior prostatectomy
- At least 1 month since prior transurethral resection
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Principal Investigator
Pascal Pommier, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Centre Leon Berard
Authority:
United States: Federal Government
Study ID:
CDR0000066684
NCT ID:
NCT00003607
Start Date:
December 1997
Completion Date:
Related Keywords:
- Prostate Cancer
- adenocarcinoma of the prostate
- stage I prostate cancer
- stage IIB prostate cancer
- stage IIA prostate cancer
- stage III prostate cancer
- Adenocarcinoma
- Prostatic Neoplasms
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