Radiation Therapy and Hormone Therapy in Treating Patients With Prostate Cancer
- Conditions
- Prostate Cancer
- Interventions
- Registration Number
- NCT00769548
- Lead Sponsor
- Radiation Therapy Oncology Group
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 1322
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 1 goserelin acetate Neoadjuvant total androgen suppression (TAS) given 2 months before and during radiation therapy (RT) to the whole pelvis followed by a prostate boost. Arm 3 low-LET photon therapy RT to the whole pelvis followed by a boost to the prostate followed by 4 months of TAS. Arm 4 goserelin acetate RT to the prostate only followed by 4 months of TAS. Arm 2 goserelin acetate Neoadjuvant TAS given 2 months before and during RT to the prostate only. Arm 3 goserelin acetate RT to the whole pelvis followed by a boost to the prostate followed by 4 months of TAS. Arm 4 low-LET photon therapy RT to the prostate only followed by 4 months of TAS. Arm 1 low-LET photon therapy Neoadjuvant total androgen suppression (TAS) given 2 months before and during radiation therapy (RT) to the whole pelvis followed by a prostate boost. Arm 2 low-LET photon therapy Neoadjuvant TAS given 2 months before and during RT to the prostate only. Arm 2 flutamide Neoadjuvant TAS given 2 months before and during RT to the prostate only. Arm 3 flutamide RT to the whole pelvis followed by a boost to the prostate followed by 4 months of TAS. Arm 1 flutamide Neoadjuvant total androgen suppression (TAS) given 2 months before and during radiation therapy (RT) to the whole pelvis followed by a prostate boost. Arm 4 flutamide RT to the prostate only followed by 4 months of TAS.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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. 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. 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. 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.