Dapagliflozin Combined With Next-generation Hormonal Agent (NHA) Versus Single NHA in Participants With Metastatic Castrate-resistant Prostate Cancer

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorYung NA

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

60 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Yung NA

Lead sponsor

The University of Hong Kong

Sponsor institution

Ruijin Hospital

Collaborator

Huashan Hospital

Collaborator