Prostate Cancer Clinical Trial
Official title:
Mansmed Trial : Repurposing Metformin as Anticancer Drug, RCT in Advanced Prostate Cancer
This study evaluate the addition of metformin to standard of care in locally advanced and metastatic prostate cancer, half the patient will receive metformin in combination with standard treatment, and the other half will receive the standard of care only
Advanced-stage PCa is usually treated with androgen-deprivation therapy (ADT). Most patients
with metastatic disease who were managed with ADT eventually progress to
castration-resistant prostate cancer (CRPC) and die of the disease. CRPC can be treated with
docetaxel, abiraterone plus prednisone, enzalutamide, and cabazitaxel, which provide limited
survival benefits. Thus, there is still a need to improve the therapeutic options available
for advanced-stage prostate cancer patients. Targeting therapy-resistant cancer stem cells
(CSCs )in prostate cancer provides a unique opportunity for novel therapeutic interventions.
Metformin, a common well-tolerated oral biguanide prescribed for type II diabetes, could be
used to sensitize prostate CSCs to current conventional anticancer therapies and improve the
efficacy of treatment. Some studies reported that Metformin could enhance the effectiveness
of ADT. Metformin augmented the antiproliferative and apoptotic effects of ADT in prostate
cancer. The combination of these two drugs significantly reduces prostate cancer cell growth
compared to monotherapy with either drug. Also, metformin might reduce the development of
CRPC.
Many studies showed that obesity and DM were linked to aggressive prostate cancer phenotype,
including biochemical failure after radical prostatectomy and external beam radiotherapy
with higher incidence of complications of ADT. Interestingly, metformin reduces the
incidence of diabetes and the adverse metabolic effects of ADT, including hyperinsulinaemia
and dyslipidaemia, and decreases myocardial infarction risk and prolongs survival in
diabetic patients.
To the best of our knowledge, after extensive computer research, there is no published
results from prospective randomized trials evaluating role of metformin among men with high
risk locally advanced or metastatic prostate cancer patients who will start treatment with
ADT.
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