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Phase III Randomized Trial of Immediate vs Delayed Hormone Therapy in Patients with Newly Diagnosed, Locally Advanced or Asymptomatic Metastatic Prostate Cancer (Summary Last Modified 04/93)
Basic Trial Information
Objectives I. Determine the overall and symptom-free survival of patients with newly diagnosed, locally advanced or asymptomatic metastatic prostate cancer treated with immediate vs. delayed hormone therapy (orchiectomy or LHRH analogue). II. Determine whether immediate hormonal therapy reduces the risk of complications, such as pathologic fractures or paraplegia, and the incidence of urethral obstruction requiring subsequent transurethral resection. III. Determine the incidence of death from nonmalignant causes prior to the development of symptoms or complications requiring therapy in patients randomized to delayed therapy. Entry Criteria Disease Characteristics: Histologically confirmed, newly diagnosed adenocarcinoma of the prostate with no clear requirement for or contraindication to immediate hormonal therapy Locally advanced (T2-4) or asymptomatic metastatic (any T, M1) M1 disease defined as any of the following: Increased uptake on bone scan consistent with metastatic disease and for which radiology confirms a metastasis or excludes nonmetastatic causes Typical metastasis on x-ray (full skeletal survey not required if bone scan is performed) Serum acid phosphatase greater than twice the upper limit of normal on at least 2 successive occasions One measurement must be at least 48 hours after instrumentation or rectal exam Prostate-specific antigen considered indicative of metastasis Prior/Concurrent Therapy: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: No prior hormonal therapy Radiotherapy: Prior or planned local radiotherapy allowed Surgery: Prior or planned transurethral prostatic resection allowed Patient Characteristics: Age: Any age Performance status: 0-2 Life expectancy: At least 1 year Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No second malignancy except basal cell skin cancer Expected Enrollment Interim analyses are performed at 6-month intervals and accrual will continue until results on one arm are clearly superior or until as large as possible a number of patients has been entered. Outline Randomized study. Arm I: Immediate Hormonal Monotherapy. Subcapsular or total orchiectomy; or LHRH Analogue Therapy with Goserelin, ZDX, NSC-606864; or Leuprolide, LEUP, NSC-377526. Choice of treatment is at the option of the physician and patient. Arm II: Delayed Hormonal Monotherapy. As in Arm I, but delayed until disease progression dictates intervention. Trial Lead Organizations Medical Research Council's Working Party on Leukemia in Adults and Children
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. |
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