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A controlled trial of castration with and without nilutamide in metastatic prostatic carcinoma
G Béland1, M Elhilali, Y Fradet
1University of Montreal.
Abstract:
A randomized double-blind trial in patients with disseminated, previously untreated prostate cancer (Stage D2) was conducted in eight Canadian centers. All 203 patients enrolled in this study underwent bilateral orchiectomy and were randomized to receive either the nonsteroidal anti-androgen nilutamide or a placebo. Patient responses were graded according to the criteria of the National Prostatic Cancer Project (NPCP). Patients treated with nilutamide had a significantly greater number of positive objective responses (partial and complete regression) than did the patients treated with castration alone (46% versus 20%, P = 0.001). Progression-free survival was improved initially in the nilutamide group, but the median time to progression was 12 months for both groups. Despite an increase in the median length of survival from 18.9 to 24.3 months with the nilutamide, the survival time was not significantly longer in the nilutamide group (log = rank test, P = 0.048). Although minor side effects were frequent, adverse effects related to the medication and leading to discontinuation of treatment were observed in 9% of cases. These results suggest some benefit of the combined treatment (orchiectomy + nilutamide) over orchiectomy alone in the treatment of metastatic prostatic carcinoma.
Insights
Adding nilutamide to orchiectomy significantly improved objective responses in metastatic prostate cancer patients. While survival was not significantly extended, this combination therapy shows promise over castration alone for advanced disease.
Area of Science:
- Oncology
- Clinical Pharmacology
- Urology
Background:
- Prostate cancer is a significant health concern, with advanced stages often requiring hormonal therapy.
- Orchiectomy (surgical castration) is a standard treatment for metastatic prostate cancer.
- Nonsteroidal anti-androgens are used to further suppress androgenic stimulation.
Purpose of the Study:
- To evaluate the efficacy and safety of adding nilutamide to bilateral orchiectomy in previously untreated patients with Stage D2 prostate cancer.
- To compare objective response rates, progression-free survival, and overall survival between nilutamide plus orchiectomy and orchiectomy alone.
Main Methods:
- A randomized, double-blind trial involving 203 patients with disseminated prostate cancer.
- Patients underwent bilateral orchiectomy and were randomized to receive either nilutamide or a placebo.
- Response assessment followed National Prostatic Cancer Project (NPCP) criteria.
Main Results:
- Nilutamide significantly increased objective response rates (46% vs. 20%, P=0.001) compared to placebo.
- Initial progression-free survival was improved with nilutamide, but median time to progression was similar (12 months) for both groups.
- Median survival increased from 18.9 to 24.3 months with nilutamide, but this difference was not statistically significant (P=0.048).
- Minor side effects were common; 9% of patients discontinued nilutamide due to adverse events.
Conclusions:
- Combined treatment with orchiectomy and nilutamide demonstrates a significant benefit in objective tumor response for metastatic prostate cancer.
- While not achieving statistical significance in overall survival, the trend suggests a potential survival advantage.
- Nilutamide is generally well-tolerated, with manageable side effects, supporting its consideration in combination therapy for advanced prostate cancer.