Effectiveness of diethylstilboestrol and low dose aspirin versus orchidectomy in the management of metastatic cancer of the prostate- a randomized trial

Abstract

Background:Bilateral orchidectornyand Diethylstilboestrol (DES) though regarded as historical therapies, still remain useful alternatives in the treatment of metastatic carcinoma of the prostate (CaP). This study aims to compare the effectiveness of DES with low dose aspirin (ASA) versus orchidectomy in resolving symptoms of CaP metastasis, reduction in' prostate specific antigen (PSA) levels and compare their adverse effects. .Methods: A randomized controlled trial was carried out at Kenyatta National hospital (KNH) ,Jtetween April and October 2010.64 patients with metastatic prostate carcinoma were randomly allocated to be treated with either Smg fDES with 75mg ASA or orchidectomy. Themain outcome measures of reduction in PSA, change in weight and haemoglobin concentration were measured at baseline, 6 weeks and 3 months. A secondary outcome measure of bone pain resolution was also assessed. Adverse events after treatment were also noted. Results:There was no significant difference in t e PSA reduction in the patients treated by orchidectomy and DES plus ASA both at 6 weeks (21.9ng/mL; 22.6ng/mL) and at 3 months (5.2ng/mL; 8.7ng/mL) (p-value =0.958). A greater proportion of patients in the DES plus ASA group had attained a PSA of ~ 4ng/mL both at 6 'weeks (36,7% vs 20.6%; p= 0.153) and at 3 months (80.7% vs 63.6%;p= 0.130).ThE:re was an increase in the mean weight and haemoglobin levels in both orchidectomy and DES arms at 6 weeks and 3 months of follow up. At 3 months of follow up 85% (17/20) of the patients in the orchidectomy arm versus 92.9% (13/14) in the DES arm (p =0.484) were pain tree. No' cardia -ascular adverse events we;e noted during the follow up period. Conclusion: 5 mg of DES combined wit 75mg of ASA is as effective as orchidectomy in managing metastatic prostate carcinoma in terms of the PSA reduction and resolution of bone pains without the excessive cardiovascular adverse events .