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

NCT07310433 | Not Yet Recruiting Phase 2

• 1 other identifier: HKURO202502
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Prostate Cancer; Metastatic Prostate Cancer

Keywords

prostate cancer; sglt2

Outcome Measures

Primary Outcomes (1)

• Progression free survival

  Progression free survival of prostate cancer per RECIST 1.1 criteria

  From date of randomization until the date of first disease progression per RECIST 1.1 criteria, assessed up to 60 months

Secondary Outcomes (3)

• Overall survival

  From date of randomization until the date of date of death from any cause, assessed up to 60 months

• Adverse Event

  All adverse events will be evaluated once every 3 months since the date of randomization, until 1 year after the end of treatment, or resolution of any treatment related adverse event, whichever is later.

• Duration of response

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months.

Study Arms (2)

Intervention

EXPERIMENTAL

dapagliflozin 10 mg daily along with standard medical care (NHA + ADT)

Drug: Dapagliflozin (10mg Tab); Drug: standard medical care (ADT + NHA)

Control

ACTIVE COMPARATOR

Standard of Care (ADT + NHA)

Drug: standard medical care (ADT + NHA)

Interventions

Dapagliflozin (10mg Tab) DRUG

Dapagliflozin (10mg Tab)

Intervention

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.

Control; Intervention

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: prostate cancer is only available on biological male with Y chromosome
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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;
• Ongoing androgen deprivation with serum testosterone \<50 ng/dL (\<1.7 nM);
• Naïve of taxane-based chemotherapy regimens;
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1;
• Normal hematologic and organ function as defined below: (a) leukocytes ≥ 3,000/mcL; (b) absolute neutrophil count ≥ 1,500/mcL; (c) platelets ≥ 100,000/mcL; (d) total bilirubin ≤ 1.5 x institutional upper limit of normal (IULN); (e) AST(SGOT)/ALT(SGPT) ≤ 3.0 x IULN; (f) estimated glomerular filtration rate eGFR ≥ 30 mL/min/1.73m2;
• Ability to understand and willingness to sign an IRB-approved written informed consent document.

You may not qualify if:

• 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;
• A history of allergic reactions attributed to compounds of similar chemical or biologic composition to dapagliflozin;
• Clinically significant abnormal serum potassium or sodium level;
• 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;
• Participation in another clinical trial with therapeutic intent within 28 days prior to enrollment;
• Inability to swallow capsules/tablets

Sponsors & Collaborators

• Yung NA: lead
• Ruijin Hospital: collaborator
• Huashan Hospital: collaborator

Study Sites (2)

Huashan Hospital

Shanghai, China

Location

Ruijin Hospital

Shanghai, China

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

dapagliflozin; Androgen Antagonists

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Yung Na, BM, MD, MPH

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Coordinator

CONTACT

852-22554852; stac@hku.hk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: November 24, 2025
• First Posted: December 30, 2025
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): October 30, 2029
• Study Completion (Estimated): October 30, 2030
• Last Updated: December 30, 2025

Record last verified: 2025-12

Locations

CN (2)