metastatic castration-resistant prostate cancer
Conditions
Interventions
Intervention group:Dapagliflozin combined with next-generation hormonal agents plus androgen deprivation therapy
Control group:Next-generation hormonal agents plus androgen deprivation therapy
Sponsors
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Age of 18 years and above; 2.Histologically or cytologically confirmed diagnosis of prostatic adenocarcinoma without neuroendocrine/ small cell histology; 3.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; 4.Current evidence of metastatic disease by radiological scan; 5.Decided to receive any of the NHA (including Abiraterone Acetate, Enzalutamide, Apalutamide or Darolutamide) under standard of care setting, or started NHA for no more than 28 days at the time of treatment period start; 6.Ongoing androgen deprivation with serum testosterone = 3,000/mcL; (b) absolute neutrophil count >= 1,500/mcL; (c) platelets >= 100,000/mcL; (d) total bilirubin = 30 mL/min/1.73m2; 10.Ability to understand and willingness to sign an IRB-approved written informed consent document;
Exclusion criteria
Exclusion criteria: 1.Current or previous treatment with SGLT2 inhibitors or thiazolidinedione; 2.Presence of type 1 diabetes mellitus, insulin-requiring diabetes mellitus or poorly controlled diabetes mellitus (i.e., HbA1c > 10%, unless approved by endocrinologist); 3.Presence of malignancies other than prostate cancer within two years prior to study enrollment; 4.Disease progressed during or after treatment with one NHA; 5.A history of allergic reactions attributed to compounds of similar chemical or biologic composition to dapagliflozin; 6.Clinically significant abnormal serum potassium or sodium level; 7.Presence of uncontrolled comorbidities including but not limited to ongoing or active infection (e.g., HIV, HBV, HCV and tuberculosis), symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, peripheral arterial disease, ketoacidosis, severe kidney disease, symptomatic hypotension, and chronic/frequent urinary tract infections or yeast infections; 8.Participation in another clinical trial with therapeutic intent within 28 days prior to enrollment; 9.Inability to swallow capsules/tablets; 10.Any medical conditions that might deem unsafe or contraindicated for inclusion in the clinical trial, per investigator’s discretion;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Radiographic Progression-Free Survival (rPFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to First Subsequent Anti-Cancer Therapy (TFST);Serious Adverse Events (SAEs);Objective Response Rate (ORR);Duration of Response (DOR);Biochemical Recurrence-Free Survival (bRFS);Time to Treatment Failure (TTF);Adverse Events (AEs);Overall Survival (OS);Laboratory Abnormalities (e.g., renal function, glucose, ketone elevation);Pain Severity;Fear of Cancer Recurrence (FCR);Quality of Life (QoL); | — |
Countries
China
Contacts
Public ContactXu Danfeng
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed