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Prostate CancerPhase 2NCT07310433

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

A Phase 2 study testing Dapagliflozin (10mg Tab) and standard medical care (ADT + NHA) in people with Prostate Cancer and Metastatic Prostate Cancer, run by Yung NA at 2 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer, Metastatic Prostate Cancer
What is being tested?
Dapagliflozin (10mg Tab) and standard medical care (ADT + NHA)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
68 participants
Where
2 sitesChina
Study dates
1 May 2026to 30 Apr 2030
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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);
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  • 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.

Who cannot join

  • 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;
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  • 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
  • Any medical conditions that might deem unsafe or contraindicated for inclusion in the clinical trial, per investigator's discretion

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Study Coordinator contact

852-22554852

stac@hku.hk

China2 sites, 2 recruiting

  • Huashan Hospital

    Shanghai

    Wu, MD, 021-96999176, ys_wu1@126.com

    Recruiting

  • Ruijin Hospital

    Shanghai

    Xiaohao Ruan, MD, 021-64370045, rxh13277@rjh.com.cn

    Recruiting

Other trials in China

About this study

Official title: 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

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.

Read the 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

Being tested
Dapagliflozin (10mg Tab), standard medical care (ADT + NHA)
Keywords
prostate cancer, sglt2
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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 groups in NCT07310433
Study groupRoleWhat they receive
InterventionExperimentaldapagliflozin 10 mg daily along with standard medical care (NHA + ADT)
Receives: Drug: Dapagliflozin (10mg Tab); Drug: standard medical care (ADT + NHA)
ControlActive comparatorStandard of Care (ADT + NHA)
Receives: Drug: standard medical care (ADT + NHA)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Radiographic Progression-Free Survival (rPFS)

    Radiographic progression-free survival is defined as the time from randomization to radiographic disease progression or death from any cause, whichever occurs first. Radiographic progression is assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 for soft-tissue lesions and standard criteria for bone metastases. Participants without documented radiographic progression or death will be censored at the date of their last radiographic assessment showing no progression.

    Measured: From randomization to radiographic disease progression or death from any cause, whichever occurs first, assessed up to 60 months.

Secondary outcomes (6)

  1. Overall Survival (OS)

    Overall survival is defined as the time from randomization to death from any cause.

    Measured: From randomization to death from any cause, assessed up to 60 months.

  2. Biochemical Recurrence-Free Survival (bRFS)

    Biochemical recurrence-free survival is defined as the time from randomization to biochemical recurrence. Biochemical recurrence is defined as an increase in prostate-specific antigen (PSA) of at least 25% and an absolute increase of at least 2 ng/mL above the nadir, confirmed by a repeat PSA measurement obtained at least 3 weeks later. PSA is assessed every 12 weeks (±2 weeks), with an additional measurement to confirm suspected biochemical recurrence.

    Measured: From randomization to biochemical recurrence, assessed up to 60 months.

  3. Time to First Subsequent Anticancer Therapy (TFST)

    Time to first subsequent anticancer therapy is defined as the time from randomization to initiation of the first subsequent anticancer therapy or death from any cause, whichever occurs first.

    Measured: From randomization to initiation of the first subsequent anticancer therapy or death from any cause, whichever occurs first, assessed up to 60 months.

  4. Time to Treatment Failure (TTF)

    Time to treatment failure is defined as the time from randomization to permanent discontinuation of the next-generation hormonal agent (NHA) and/or dapagliflozin due to disease progression, toxicity, or death.

    Measured: From randomization to treatment failure, assessed up to 60 months.

  5. Objective Response Rate (ORR)

    Objective response rate is defined as the percentage of participants with measurable disease who achieve a complete response or partial response according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

    Measured: From randomization to radiographic disease progression, assessed up to 60 months.

  6. Duration of Response (DOR)

    Duration of response is evaluated in participants who achieve a complete response or partial response according to RECIST version 1.1.

    Measured: From the date of first documented complete or partial response to radiographic disease progression or death from any cause, whichever occurs first, assessed up to 60 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Dec 2025
  2. Study start1 May 2026
  3. Primary completion30 Apr 2029 (estimated)
  4. Study completion30 Apr 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
68 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07310433
Sponsor's protocol ID
HKURO202502
Status last verified
Oct 2026
First submitted
24 Nov 2025
Last updated
28 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data underlying the findings reported in publications arising from this trial will be made available upon reasonable request, subject to applicable legal and ethical requirements.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Dapagliflozin (10mg Tab) and standard medical care (ADT + NHA) in people with Prostate Cancer and Metastatic Prostate Cancer, run by Yung NA at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Study Coordinator (852-22554852, stac@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Radiographic Progression-Free Survival (rPFS) (time frame: From randomization to radiographic disease progression or death from any cause, whichever occurs first, assessed up to 60 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07310433.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.

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