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

ConditionsProstate CancerMetastatic Prostate Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorYung NA

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: InterventionExperimental treatment 2 interventions
Group B: ControlActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Progression free survival

Progression free survival of prostate cancer per RECIST 1.1 criteria

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

Secondary outcomes

1

Overall survival

Overall survival

Time frame
From date of randomization until the date of date of death from any cause, assessed up to 60 months
2

Adverse Event

Adverse Event of combination therapy (dapagliflozin + ADT + NHA)

Time frame
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.
3

Duration of response

The time from randomization to disease progression or death, only in patients who achieve complete or partial response

Time frame
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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Yung NA

Lead sponsor

The University of Hong Kong

Sponsor institution

Ruijin Hospital

Collaborator

Huashan Hospital

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: