Dapagliflozin combined with next-generation hormonal agent (NHA) versus single NHA in participants with metastatic castrate-resistant prostate cancer: a phase 2, multicenter, open-label, randomized controlled trial
Description: Objectives: To evaluate the effects of SGLT2 inhibitors (Dapagliflozin) combined with first-line next-generation hormonal agent (NHA) in patients with metastatic castrate-resistant prostate cancer (mCRPC).
Hypothesis to be tested: Dapagliflozin may be repurposed as a non-castrating therapy for mCRPC, and these patients may derive greater benefit from Dapagliflozin in combination with the first-line NHA.
Design and subjects: A phase 2 multicenter, open-label RCT will be performed in Queen Mary Hospital, Ruijin Hospital and Huashan Hospital with 60 mCRPC patients proposed to be recruited.
Study instruments: Data will be collected through radiological scan, laboratory test, questionnaire and case report form.
Interventions: Eligible patients will be randomized into two treatment groups with a 1:1 ratio. Patients in the test group will receive Dapagliflozin plus NHA plus ADT while those in the control group will receive NHA plus ADT.
Main outcome measures: The primary outcome is radiographic progression-free survival. Secondary outcomes include overall survival, biomedical recurrence-free survival, time to first subsequent anti-cancer therapy, time to treatment failure, objective response rate and duration of response. Exploratory outcomes include treatment-related adverse events, quality of life, fear of cancer recurrence, and severity of pain.
Data analysis: The primary analysis is efficacy analysis based on the intention-to-treat population. Hazard ratios will be calculated using Cox regression. Interim and finial analyses will be performed upon different study stages.
Expected results: Repurposed SGLT2 inhibitors will be effective and safe in the combination therapy for mCRPC, which may further improve the clinical practice guidelines on prostate cancer treatment and management.
Funder: Health and Medical Research Fund
Amount: HKD 1,421,000
Funding type: grant
Funder scheme: HMRF - Advanced Medical Research
Start date: 2024-01-01
Investigator: Yung NA
Institution: Department of Surgery, The University of Hong Kong
Funded outputs count: 1
Funder award ID: 13241646
OpenAlex ID: G27500179