Prostate Cancer
Conditions
Keywords
adenocarcinoma of the prostate, stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer, stage IV prostate cancer
Brief summary
RATIONALE: Radiation therapy uses high energy x-rays to damage tumor cells. Hormone therapy combined with radiation therapy may be a more effective treatment for prostate cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of four different combinations of radiation and hormone therapy in treating patients with prostate cancer.
Detailed description
OBJECTIVES: I. Examine whether total androgen suppression (TAS) with flutamide/goserelin and whole-pelvic irradiation followed by a cone-down boost to the prostate improves progression-free survival at 5 years by at least 10% compared to TAS and prostate-only irradiation in patients with adenocarcinoma of the prostate at significant risk of nodal involvement. II. Examine whether induction and concurrent (neoadjuvant) TAS and radiotherapy improves the progression-free survival at 5 years by at least 10% compared to adjuvant TAS and radiotherapy. III. Compare treatments with regard to local control, time to distant failure, and overall survival. OUTLINE: Randomized study. Arm I: Neoadjuvant Antiandrogen Therapy with Radiotherapy. Flutamide, FLUT, NSC-147834; Goserelin, Zoladex, ZDX, NSC-606864; with irradiation of the whole pelvis followed by a boost to the prostate using photons of at least 6 MV. Arm II: Neoadjuvant Antiandrogen Therapy with Radiotherapy; FLUT; ZDX; with irradiation of the prostate using equipment as in Arm I. Arm III: Radiotherapy followed by Adjuvant Antiandrogen Therapy. Irradiation as in Arm I; followed by FLUT; ZDX. Arm IV: Radiotherapy followed by Adjuvant Antiandrogen Therapy. Irradiation as in Arm II; followed by FLUT; ZDX. PROJECTED ACCRUAL: 1,200 patients will be accrued over 2.5 years.
Interventions
DRUGflutamide
Drug used for TAS.
DRUGgoserelin acetate
Drug used for TAS.
RADIATIONlow-LET photon therapy
radiation therapy
Sponsors
National Cancer Institute (NCI)
Radiation Therapy Oncology Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
No minimum to 120 Years
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the prostate Any stage with an estimated risk of node involvement at least 15% (and therefore at significant risk for local and/or systemic failure) based on pretreatment PSA and Gleason score (GS), e.g.: GS of 7 and PSA greater than 7.5 ng/mL GS of 6 and PSA greater than 22.5 ng/mL GS of 5 and PSA greater than 37.5 ng/mL PSA greater than 4 and less than 100 ng/mL Highest pretreatment value determined by a monoclonal assay that has a normal range of 0-4 ng/mL PSA measured by polyclonal assay (e.g., Yang) that has a normal range of 0-2.5 ng/mL may need to be divided by a conversion factor of approximately 1.5 GS determination required prior to entry No distant metastases No biopsy proven lymph node involvement Ineligible for protocol RTOG-9408 (clinical stages T2c-T4 with GS of 6 or higher are eligible for this study) PATIENT CHARACTERISTICS: Age: Any age Performance status: Karnofsky 70-100% Hematopoietic: Not specified Hepatic: Liver function tests no greater than 1.2 times normal Renal: Not specified Other: No major medical or psychiatric illness that would prevent completion of treatment or interfere with follow-up No second malignancy within 5 years except superficial nonmelanomatous skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: At least 90 days since testosterone At least 60 days since finasteride Radiotherapy: No prior radiotherapy Surgery: No more than 60 days since surgical staging No radical surgery or cryosurgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival (Arms 1, 3 vs. Arms 2, 4) | From randomization to the first occurrence of biochemical failure, clinical failure (local or distant), death from any cause, or last follow-up. Analysis occurs after all patients have been potentially followed for 5 years. |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival (Arms 1, 2 vs. Arms 3, 4) | From randomization to the first occurrence of biochemical failure, clinical failure (local or distant), death from any cause, or last follow-up. Analysis occurs after all patients have been potentially followed for 5 years. |
| Local progression | From randomization to the date of local progression or last follow-up. Analysis occurs after all patients have been potentially followed for 5 years. |
| Distant metastasis | From randomization to the date of metastatic disease or last follow-up. Analysis occurs after all patients have been potentially followed for 5 years. |
| Overall survival | From the date of randomization to the date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 5 years. |
Outcome results
None listed