About this trial
Dapagliflozin is a well-established medication being marketed and used for treatment Type 2 diabetes mellitus (T2DM). In retrospective cohort studies done by our team, we found that metastatic prostate cancer patients who received Dapagliflozin together with standard anti-cancer treatment, androgen deprivation therapy (ADT) combined with novel hormonal agent (NHA), had better tumor control than those having ADT and NHA.
Eligibility criteria
Qualifiers
Age of 18 years and above
Histologically or cytologically confirmed diagnosis of prostatic adenocarcinoma without neuroendocrine/ small cell histology;
PCa progression while receiving ADT (or post bilateral orchiectomy) within 6 months before screening: two consecutive rising PSA levels, radiographic soft tissue or bone progression;
Current evidence of metastatic disease by radiological scan;
Disqualifiers
Current or previous treatment with SGLT2 inhibitors or thiazolidinedione;
Presence of type 1 diabetes mellitus, insulin-requiring diabetes mellitus or poorly controlled diabetes mellitus (i.e., HbA1c > 10%, unless approved by endocrinologist);
Presence of malignancies other than prostate cancer within two years prior to study enrollment;
Disease progressed during or after treatment with one NHA;
Trial design
Treatments tested in this trial
- Dapagliflozin (10mg Tab)
- standard medical care (ADT + NHA)
Treatment groups
Sponsors and collaborators
Yung NA
Lead sponsor
The University of Hong Kong
Sponsor institution
Ruijin Hospital
Collaborator
Huashan Hospital
Collaborator