NCT07310433

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

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Yung NA · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Androgen deprivation therapy (ADT) combined with novel hormonal agent (NHA) is a standard treatment for metastatic castrate-resistant prostate cancer (mCRPC) but treatment failure and side effects remain significant concerns. Researchers are identifying non-castrating therapies to improve treatment tolerance and quality of life. Recently, the anti-tumor effect of sodium-glucose cotransporter 2 (SGLT2) inhibitors has been revealed in vitro, vivo, and population-based observational studies. However, only one phase I trial has assessed their safety in PCa, and no randomized controlled trial (RCT) has evaluated their efficacy. A phase 2 multicenter, open-label RCT will be performed in Queen Mary Hospital, Ruijin Hospital and Huashan Hospital (subject to Ethics Committee approval at each center) with 60 mCRPC patients proposed to be recruited. Data will be collected through radiological scan, laboratory test and case report form. Eligible patients will be randomized into two treatment groups with a 1:1 ratio. Patients in the test group will receive dapagliflozin on top of NHA plus ADT while those in the control group will receive standard of care NHA plus ADT. 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. 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. This study will be the first RCT to evaluate the efficacy and safety of SGLT2 inhibitors combined with the first-line next-generation hormonal agent (NHA) for mCRPC treatment. Given their general tolerability and clinical use, repurposing SGLT2 inhibitors as a non-castrating therapy may lead to better outcomes for PCa patients. Findings of this study will inform a novel combination therapy for advanced PCa, potentially enhancing clinical practice guidelines for its treatment and management in Hong Kong and mainland China

Conditions

• Prostate Cancer
• Metastatic Prostate Cancer

Interventions

Type	Name	Description
DRUG	Dapagliflozin (10mg Tab)	Dapagliflozin (10mg Tab)
DRUG	standard medical care (ADT + NHA)	standard medical care for metastatic prostate cancer (ADT + NHA), the choice of NHA and ADT to be agreed among participant and treating physician with dosage and frequency according to local guideline. Surgical castration is also acceptable as ADT.

Timeline

• Start date: 2026-06-01
• Primary completion: 2029-10-30
• Completion: 2030-10-30
• First posted: 2025-12-30
• Last updated: 2025-12-30

Locations

2 sites across 1 country: China