BIOMAT Database Logo BIOMAT Database Logo

Orchiectomy and nilutamide or placebo as treatment of metastatic prostatic cancer in a multinational double-blind randomized trial. 1993

R A Janknegt, and C C Abbou, and R Bartoletti, and L Bernstein-Hahn, and B Bracken, and J M Brisset, and F C Da Silva, and G Chisholm, and E D Crawford, and F M Debruyne
Department of Urology, University Hospital Maastricht, The Netherlands.

The efficacy and tolerance of the nonsteroidal antiandrogen nilutamide in the treatment of prostatic cancer were studied in a large double-blind clinical trial initiated in 1986. Patients with metastatic prostatic cancer without prior endocrine manipulation underwent orchiectomy and were randomized to 1 of 2 groups receiving nilutamide (225 patients) or placebo (232). Nilutamide and placebo were evaluated for efficacy in 207 and 216 patients, respectively. Progression-free survival was significantly longer in the nilutamide group (median time to progression 20.8 months on nilutamide and 14.9 months on placebo, p = 0.005). Median time to death from prostatic cancer was 30.0 months in the placebo group and 37 months in the nilutamide group. Objective regressions were higher in the nilutamide group (41%) than in the placebo group (24%). Significant differences in favor of the nilutamide group were found at several intervals for bone pain, prostatic acid phosphatase, prostate specific antigen, alkaline phosphatase and bone scan isotope uptake. Nilutamide and orchiectomy constitute a more effective treatment for metastatic prostatic cancer than orchiectomy alone, and the adverse effects of nilutamide, usually minor, are outweighed by the significant improvements in most disease measures and progression-free survival.

UI MeSH Term Description Entries
D007093 Imidazoles Compounds containing 1,3-diazole, a five membered aromatic ring containing two nitrogen atoms separated by one of the carbons. Chemically reduced ones include IMIDAZOLINES and IMIDAZOLIDINES. Distinguish from 1,2-diazole (PYRAZOLES).
D008297 Male Males
D008875 Middle Aged An adult aged 45 - 64 years. Middle Age
D009919 Orchiectomy The surgical removal of one or both testicles. Castration, Male,Orchidectomy,Castrations, Male,Male Castration,Male Castrations,Orchidectomies,Orchiectomies
D011467 Prostate A gland in males that surrounds the neck of the URINARY BLADDER and the URETHRA. It secretes a substance that liquefies coagulated semen. It is situated in the pelvic cavity behind the lower part of the PUBIC SYMPHYSIS, above the deep layer of the triangular ligament, and rests upon the RECTUM. Prostates
D011471 Prostatic Neoplasms Tumors or cancer of the PROSTATE. Cancer of Prostate,Prostate Cancer,Cancer of the Prostate,Neoplasms, Prostate,Neoplasms, Prostatic,Prostate Neoplasms,Prostatic Cancer,Cancer, Prostate,Cancer, Prostatic,Cancers, Prostate,Cancers, Prostatic,Neoplasm, Prostate,Neoplasm, Prostatic,Prostate Cancers,Prostate Neoplasm,Prostatic Cancers,Prostatic Neoplasm
D001859 Bone Neoplasms Tumors or cancer located in bone tissue or specific BONES. Bone Cancer,Cancer of Bone,Cancer of the Bone,Neoplasms, Bone,Bone Neoplasm,Neoplasm, Bone
D003131 Combined Modality Therapy The treatment of a disease or condition by several different means simultaneously or sequentially. Chemoimmunotherapy, RADIOIMMUNOTHERAPY, chemoradiotherapy, cryochemotherapy, and SALVAGE THERAPY are seen most frequently, but their combinations with each other and surgery are also used. Multimodal Treatment,Therapy, Combined Modality,Combined Modality Therapies,Modality Therapies, Combined,Modality Therapy, Combined,Multimodal Treatments,Therapies, Combined Modality,Treatment, Multimodal,Treatments, Multimodal
D004311 Double-Blind Method A method of studying a drug or procedure in which both the subjects and investigators are kept unaware of who is actually getting which specific treatment. Double-Masked Study,Double-Blind Study,Double-Masked Method,Double Blind Method,Double Blind Study,Double Masked Method,Double Masked Study,Double-Blind Methods,Double-Blind Studies,Double-Masked Methods,Double-Masked Studies,Method, Double-Blind,Method, Double-Masked,Methods, Double-Blind,Methods, Double-Masked,Studies, Double-Blind,Studies, Double-Masked,Study, Double-Blind,Study, Double-Masked
D005500 Follow-Up Studies Studies in which individuals or populations are followed to assess the outcome of exposures, procedures, or effects of a characteristic, e.g., occurrence of disease. Followup Studies,Follow Up Studies,Follow-Up Study,Followup Study,Studies, Follow-Up,Studies, Followup,Study, Follow-Up,Study, Followup

Related Publications

R A Janknegt, and C C Abbou, and R Bartoletti, and L Bernstein-Hahn, and B Bracken, and J M Brisset, and F C Da Silva, and G Chisholm, and E D Crawford, and F M Debruyne
Selinexor in Advanced, Metastatic Dedifferentiated Liposarcoma: A Multinational, Randomized, Double-Blind, Placebo-Controlled Trial.
August 2022, Journal of clinical oncology : official journal of the American Society of Clinical Oncology,
R A Janknegt, and C C Abbou, and R Bartoletti, and L Bernstein-Hahn, and B Bracken, and J M Brisset, and F C Da Silva, and G Chisholm, and E D Crawford, and F M Debruyne
Total androgen blockade with the use of orchiectomy and nilutamide (Anandron) or placebo as treatment of metastatic prostate cancer. Anandron International Study Group.
December 1993, Cancer,
R A Janknegt, and C C Abbou, and R Bartoletti, and L Bernstein-Hahn, and B Bracken, and J M Brisset, and F C Da Silva, and G Chisholm, and E D Crawford, and F M Debruyne
Treatment of symptomatic metastatic prostatic cancer with cyproterone acetate versus orchiectomy: a prospective randomized trial.
January 1991, Urologia internationalis,
R A Janknegt, and C C Abbou, and R Bartoletti, and L Bernstein-Hahn, and B Bracken, and J M Brisset, and F C Da Silva, and G Chisholm, and E D Crawford, and F M Debruyne
[Therapy of metastatic prostatic cancer by orchiectomy plus Anandron versus orchiectomy plus placebo. Initial results of a randomized multicenter study].
August 1989, Helvetica chirurgica acta,
R A Janknegt, and C C Abbou, and R Bartoletti, and L Bernstein-Hahn, and B Bracken, and J M Brisset, and F C Da Silva, and G Chisholm, and E D Crawford, and F M Debruyne
Efficacy and Safety of Quxie Capsule () in Metastatic Colorectal Cancer: A Double-Blind Randomized Placebo Controlled Trial.
March 2018, Chinese journal of integrative medicine,
R A Janknegt, and C C Abbou, and R Bartoletti, and L Bernstein-Hahn, and B Bracken, and J M Brisset, and F C Da Silva, and G Chisholm, and E D Crawford, and F M Debruyne
Multicenter, randomized, double-blind phase 2 trial of FOLFIRI with regorafenib or placebo as second-line therapy for metastatic colorectal cancer.
August 2018, Cancer,
R A Janknegt, and C C Abbou, and R Bartoletti, and L Bernstein-Hahn, and B Bracken, and J M Brisset, and F C Da Silva, and G Chisholm, and E D Crawford, and F M Debruyne
Trimethoprim as adjuvant treatment in schizophrenia: a double-blind, randomized, placebo-controlled clinical trial.
July 2010, Schizophrenia bulletin,
R A Janknegt, and C C Abbou, and R Bartoletti, and L Bernstein-Hahn, and B Bracken, and J M Brisset, and F C Da Silva, and G Chisholm, and E D Crawford, and F M Debruyne
A double-blind, placebo-controlled, randomized trial of oral sodium clodronate for metastatic prostate cancer (MRC PR05 Trial).
September 2003, Journal of the National Cancer Institute,
R A Janknegt, and C C Abbou, and R Bartoletti, and L Bernstein-Hahn, and B Bracken, and J M Brisset, and F C Da Silva, and G Chisholm, and E D Crawford, and F M Debruyne
Tegaserod for the treatment of chronic constipation: a randomized, double-blind, placebo-controlled multinational study.
February 2005, The American journal of gastroenterology,
R A Janknegt, and C C Abbou, and R Bartoletti, and L Bernstein-Hahn, and B Bracken, and J M Brisset, and F C Da Silva, and G Chisholm, and E D Crawford, and F M Debruyne
Efficacy of the combination of nilutamide plus orchidectomy in patients with metastatic prostatic cancer. A meta-analysis of seven randomized double-blind trials (1056 patients).
April 1994, British journal of urology,
Copied contents to your clipboard!