Phase III Comparison of Early vs Delayed Endocrine Manipulation (Orchiectomy or LHRH Agonist Therapy) in Previously Untreated Patients with Nonmetastatic Asymptomatic Carcinoma of the Prostate
Early Compared With Delayed Hormone Therapy in Treating Patients With Nonmetastatic Prostate Cancer
Basic Trial Information
|Phase III||Treatment||Closed||80 and under||EORTC-30891|
I. Compare, in a randomized Phase III multi-institutional setting, symptom-free survival time of patients with asymptomatic carcinoma of the prostate (T0-4, N0-2, M0) not suited for local curative treatment who are randomly assigned to immediate vs. delayed endocrine intervention (orchiectomy or LHRH agonist therapy). II. Compare the overall survival of these two groups of patients. III. Compare the time to first evidence of distant progression (N4 or M1) of these two treatment groups. IV. Evaluate the prognostic significance of pretreatment laboratory data and monitor these parameters following endocrine therapy. V. Study the prognosis of various sub-groups of patients stratified according to performance status, local tumor extent, nodal status, and choice of endocrine treatment.
Histologically or cytologically proven carcinoma of the prostate Stage T0-4, N0-2 (smaller than 5 cm), M0 disease not amenable to potentially curative local treatment (radical prostatectomy or radiotherapy) Nodal status determined by CT or ultrasound and preferably confirmed cytologically No more than 1 month since diagnosis Asymptomatic aside from disturbance in voiding No ureteral obstruction or other evidence of locally advanced disease that could lead to fatal complications (e.g., rectal stenosis, thrombosis of pelvic veins) if left untreated Willing to undergo orchiectomy or receive continuous LHRH analogue treatment
Biologic therapy: No prior therapy Chemotherapy: No prior therapy Endocrine therapy: No prior endocrine therapy Radiotherapy: No prior radiotherapy Surgery: No prior radical prostatectomy TURP for voiding difficulties allowed
Age: No greater than 80 Performance status: WHO 0 or 1 Life expectancy: At least 6 months Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No second malignancy within 10 years except treated basal cell carcinoma of the skin
Approximately 750 patients will be entered in order to achieve the required 612 evaluable patients. A 6-year accrual period is anticipated.
Randomized study. All patients select the type of endocrine therapy they are ultimately to receive prior to randomization. Arm I: Immediate Endocrine Therapy. Orchiectomy or LHRH Agonist Therapy plus (initially) Antiandrogen Therapy. Buserelin, BSRL; Cyproterone acetate, CPTR, NSC-81430. Treatment initiated within 1 month of randomization. Arm II: Delayed Endocrine Therapy. Orchiectomy or LHRH Therapy plus (initially) Antiandrogen Therapy. BSRL; CPTR. Treatment delayed until onset of symptoms.
Studer UE, Collette L, Whelan P, et al.: Using PSA to guide timing of androgen deprivation in patients with T0-4 N0-2 M0 prostate cancer not suitable for local curative treatment (EORTC 30891). Eur Urol 53 (5): 941-9, 2008.[PUBMED Abstract]
Studer UE, Collette L, Whelan P, et al.: PSA decline from baseline is not a prognostic factor for outcome in hormonally treated patients with T0-4N0M0 prostate cancer not suitable for local treatment with curative intent treated in EORTC 30891. [Abstract] American Urological Association: Annual Meeting, May 20-25, 2006, Atlanta, GA A-664, 2006.
Studer UE, Collette L, Whelan P: Patients with T0-4N0M0 prostate cancer not suitable for local treatment with curative intent (EORTC 30891): which subgroup needs or does not need immediate treatment? [Abstract] American Urological Association: Annual Meeting, May 20-25, 2006, Atlanta, GA A-1592, 2006.
Studer UE, Collette L, Whelan P, et al.: Baseline PSA and PSA doubling time predict the risk of objective progression and death in patients with T0-4 N0-2 M0 prostate cancer on watchful waiting. [Abstract] American Urological Association: Annual Meeting, May 20-25, 2006, Atlanta, GA A-665, 2006.
Studer UE, Whelan P, Albrecht W, et al.: Immediate or deferred androgen deprivation for patients with prostate cancer not suitable for local treatment with curative intent: European Organisation for Research and Treatment of Cancer (EORTC) Trial 30891. J Clin Oncol 24 (12): 1868-76, 2006.[PUBMED Abstract]
Studer UE, Switzerland B, Whelan P, et al.: Immediate versus deferred androgen deprivation in patients with asymptomatic prostate cancer T0-4 N0-2 M0 not suitable for local definitive treatment. [Abstract] J Urol 173 (Suppl 4): A-1659, 2005.
Trial Contact Information
Trial Lead Organizations
European Organization for Research and Treatment of Cancer
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.