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

Sponsor
Yung NA
Study ID
NCT07310433
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dapagliflozin (10mg Tab) — DRUG
    Dapagliflozin (10mg Tab)
  • standard medical care (ADT + NHA) — DRUG
    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.

Study Details

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.

Key Dates

Start date
Jun 1, 2026
Status verified
Dec 2025
Primary completion
Oct 30, 2029
Completion
Oct 30, 2030

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Intervention
    dapagliflozin 10 mg daily along with standard medical care (NHA + ADT)
  • Active Comparator: Control
    Standard of Care (ADT + NHA)

Primary Outcome Measure

Progression free survival [ Time Frame: From date of randomization until the date of first disease progression per RECIST 1.1 criteria, assessed up to 60 months ]

Central Contacts

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