radiation therapy and hormone therapy in treating patients with prostate cancer

Conditions: Prostate Cancer

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.

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.

Eligibility 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

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