Dapagliflozin added to a next-generation hormonal therapy for metastatic prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2, multicenter, open-label study compares dapagliflozin plus usual androgen deprivation therapy and next-generation hormonal agent therapy against standard care. Sixty participants with metastatic castration-resistant prostate cancer will be randomized 1:1 to receive either dapagliflozin in addition to NHA and ADT or the standard NHA plus ADT alone. The primary outcome is radiographic progression-free survival, with secondary outcomes including overall survival, biochemical recurrence-free survival, time to first subsequent therapy, time to treatment failure, objective response rate, and duration of response. Exploratory outcomes will examine treatment-related adverse events and tolerability. Data will be collected via imaging, labs, and case report forms across participating centers in Shanghai, China.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Exclusion Criteria:

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

Where it's running

• Huashan Hospital
  Shanghai, China Recruiting
• Ruijin Hospital
  Shanghai, China Recruiting

Study contacts

• Principal investigator: Yung Na, BM, MD, MPH — The University of Hong Kong
• Study coordinator: Study Coordinator
• Email: stac@hku.hk
• Phone: 852-22554852

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• JANX013 and JANX007 combo in advanced prostate cancer

  A first-in-human study will test JANX013 together with JANX007 to see if this combination is safe and tolerable in adults with metastatic castration-resistant prostate cancer.

  Recruiting Phase 1 Janux Therapeutics · Nashville, Tennessee · NCT07813637

• Prostate Radiotherapy and Metastasis-Directed Therapy in Synchronous Oligometastatic Prostate Cancer

  This registry follows men with new, limited metastatic prostate cancer who receive targeted radiotherapy to the prostate and all visible metastases to see how they do over time in real-world care.

  Recruiting Affidea Nu-med Center of Oncological DIagnostics and Therapy · Zamość, Lublin Voivodeship · NCT07686016

• PSMA-targeted therapy with hormone suppression for low-volume metastatic prostate cancer

  This phase II trial tests leuprolide acetate alone versus with 177Lu-PSMA-617 (with or without abiraterone acetate and prednisone) in men with hormone-sensitive, low-volume metastatic prostate cancer.

  Recruiting Phase 2 Mayo Clinic · Rochester, Minnesota · NCT07650240

• Actinium (225Ac) PSMA therapy for castration‑resistant prostate cancer after Lutetium

  This trial will test whether an injectable Actinium-225 PSMA treatment can control advanced prostate cancer in men whose disease progressed after Lutetium‑PSMA therapy.

  Recruiting Phase 1/2 University College, London · London · NCT07414940

• Combining Lutetium-177 PSMA targeted therapy with liver-directed treatment for prostate cancer spread to the liver

  This trial tests whether giving Lutetium-177 PSMA targeted radiation together with liver-directed treatments helps men with metastatic castration‑resistant prostate cancer that has spread to the liver and who progressed on prior androgen pathway inhibitors.

  Recruiting Phase 1 University of California, San Francisco · San Francisco, California · NCT07145177

• Home-based telerehabilitation for rural men on hormone therapy for metastatic prostate cancer

  This trial tests whether a home telerehabilitation program helps men in rural areas receiving androgen deprivation therapy for metastatic prostate cancer feel and function better than home exercise without the technology.

  Recruiting University of Utah · Salt Lake City, Utah · NCT07032584

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.