Phase III Comparison of Flutamide vs Placebo Following Bilateral Orchiectomy in Patients with Stage D2 Adenocarcinoma of the Prostate
Basic Trial Information
|Phase III||Treatment||Closed||any age||NCI||SWOG-8894|
I. Compare, in a randomized, blinded Phase III setting, overall survival and progression-free survival of patients with histologically documented Stage D2 adenocarcinoma of the prostate randomly assigned to treatment with flutamide vs. placebo following bilateral orchiectomy. II. Compare qualitative and quantitative toxicities of the two treatment regimens.
Histologically proven pathologic Stage D2 adenocarcinoma of the prostate Repeat biopsy not needed to confirm clinically obvious metastatic disease with prior history of prostate cancer Histologic proof required when a different primary site is suspected (i.e., a single lung metastasis, hepatic metastasis, or other unusual presentations) Ineligible for any higher priority SWOG protocol Evidence of progressive metastatic disease required (measurable disease not required) Concurrent registration on SWOG-9039 (quality-of-life protocol) required and on SWOG-9205 (Prostate-specific antigen study) optional Patients who do not understand English are not required to enter SWOG-9039
Biologic therapy: No prior or concomitant biological response modifier therapy Chemotherapy: No prior or concomitant chemotherapy Endocrine therapy: No prior or concomitant endocrine therapy Radiotherapy: Prior radiotherapy allowed if metastatic disease is evident Concomitant palliative radiotherapy allowed for control of severe pain or epidural cord compression during the first 4 weeks of treatment Irradiated lesions may not be used for objective or subjective response assessment) Surgery: Prior surgical treatment allowed if metastatic disease is evident Recovery from effects of any major surgery required
Age: Any age Performance status: SWOG 0-2 (SWOG 3 allowed if secondary to pain) Hematopoietic: WBC at least 3,000 Hepatic: Bilirubin normal SGOT no more than 2 x ULN Elevations due to liver metastases (confirmed by immunoperoxidase staining for acid phosphatase and prostatic-specific antigen) allowed if cleared with Study Coordinator Renal: Creatinine no more than 2 x ULN Abnormal renal function secondary to obstruction by prostatic cancer will requires urological management with stent or nephrostomy tube and must be cleared with Study Coordinator Other: No major active infection No significant medical illness that would preclude protocol treatment or compromise survival No second malignancy within 5 years except: Adequately treated nonmelanomatous skin cancer Any in situ carcinoma Blood/body fluid analyses to determine eligibility and imaging studies and physical exams for tumor measurement completed within 14 days prior to registration; screening exams other than blood/body fluid analyses and imaging studies of nonmeasurable disease or uninvolved organs completed within 42 days prior to registration
Approximately 1,250 patients will be entered over about 2.6 years.
Double-blind, randomized study. Patients undergo bilateral orchiectomy within 1 week following registration and begin treatment on Arm I or II within 4 working days following orchiectomy. Arm I: Antiandrogen Therapy. Flutamide, FLUT, NSC-147834. Arm II: Control: Placebo.
Beer TM, Tangen CM, Bland LB, et al.: The prognostic value of hemoglobin change after initiating androgen-deprivation therapy for newly diagnosed metastatic prostate cancer: A multivariate analysis of Southwest Oncology Group Study 8894. Cancer 107 (3): 489-96, 2006.[PUBMED Abstract]
Glass TR, Tangen CM, Crawford ED, et al.: Metastatic carcinoma of the prostate: identifying prognostic groups using recursive partitioning. J Urol 169 (1): 164-9, 2003.[PUBMED Abstract]
Tangen C, Crawford ED, Faulkner J, et al.: Ten-year survival in patients with metastatic (M+) prostate cancer (CaP): analysis of Southwest Oncology Group (SWOG) 8894. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-749, 2002.
Thompson IM, Tangen C, Basler J, et al.: Impact of previous local treatment for prostate cancer on subsequent metastatic disease. J Urol 168 (3): 1008-12, 2002.[PUBMED Abstract]
Thompson IM, Basler J, Tangen C, et al.: Does a prior radical prostatectomy (RP) alter outcome of hormonal therapy for metastatic (M+) prostate cancer. [Abstract] J Urol 165 (5 suppl): A-689, 168, 2001.
Thompson I, Tangen C, Tolcher A, et al.: Association of African-American ethnic background with survival in men with metastatic prostate cancer. J Natl Cancer Inst 93 (3): 219-25, 2001.[PUBMED Abstract]
Thompson I, Tolcher A, Crawford ED, et al.: African American ethnic background is an independent and negative predictor of survival in metastatic prostate cancer. [Abstract] J Urol 163 (4 suppl): A-242, 56, 2000.
Eisenberger MA, Blumenstein BA, Crawford ED, et al.: Bilateral orchiectomy with or without flutamide for metastatic prostate cancer. N Engl J Med 339 (15): 1036-42, 1998.[PUBMED Abstract]
Eisenberger M, Crawford ED, McLeod D, et al.: A comparison of bilateral orchiectomy (orch) with or without flutamide in stage D2 prostate cancer (PC) (NCI INT-0105 SWOG/ECOG) . [Abstract] Proceedings of the American Society of Clinical Oncology 16: A-3, 2a, 1997.
Moinpour C, Savage M, Lovato L, et al.: Quality of life endpoints in advanced stage prostate cancer: a randomized double-blind study comparing flutamide to plecebo in orchiectomized stage D2 prostate patients. [Abstract] Proceedings of the American Society of Clinical Oncology 16: A183, 1997.
Eisenberger M, Crawford ED, McLeod D, et al.: The prognostic significance of prostate specific antigen (PSA) in stage D2 prostate cancer (PC) interim evaluation of intergroup study 0105. [Abstract] Proceedings of the American Society of Clinical Oncology 14: A-613, 235, 1995.
Hussain M, Tangen CM, Higano CS, et al.: Improved overall survival (OS) of patients (pts) with new metastatic prostate cancer (pca): better efficacy or stage migration? Data from SWOG: S9346 and 8894. [Abstract] 2010 Genitourinary Cancers Symposium, March 5-7, 2010, San Francisco, California. A-30, 2010.
Montgomery RB, Goldman B, Tangen CM, et al.: Association of body mass index with response and survival in men with metastatic prostate cancer: Southwest Oncology Group trials 8894 and 9916. J Urol 178 (5): 1946-51; discussion 1951, 2007.[PUBMED Abstract]
Blumenstein BA: Some statistical considerations for the interpretation of trials of combined androgen therapy. Cancer 72 (12 Suppl): 3834-40, 1993.[PUBMED Abstract]
Trial Contact Information
Trial Lead Organizations
Southwest Oncology Group
Eastern Cooperative Oncology Group
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.