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 .