#1 Clinical Trials Search in Europe

Hydrocortisone Acetate

Clinical trials investigating Hydrocortisone Acetate are studying how it performs in different patient groups, including people with advanced prostate cancer, selected solid tumors, and septic shock. These studies look at safety, tolerability, and treatment effects such as cancer control and short-term survival. The trials include different phases and treatment settings.

Table of contents

Trial overview

The trial data show three authorised interventional studies that include Hydrocortisone Acetate as part of the treatment plans.[1][2][3] These studies are in different phases: Phase 1, Phase 3, and Phase 4.[1][2][3]

The trials cover both cancer and critical care research, so the target populations are very different from one another.[1][2][3] The main study goals include safety, tolerability, and treatment effect measures such as cancer response and short-term survival.[1][2][3]

Study in metastatic castration resistant prostate cancer

NCT06353386 is a Phase 1 interventional study in people with metastatic castration resistant prostate cancer (mCRPC).[1] The study is authorised and has an enrollment of 311 participants.[1]

This study is called “Study of MK-5684-based Therapies in Advanced Prostate Cancer” and includes Hydrocortisone and other drugs in different treatment combinations.[1] The brief summary says the safety lead-in is used to evaluate safety and tolerability and to establish a recommended Phase 2 dose, often called RP2D, which means the dose plan chosen for later testing.[1]

The study also includes an efficacy phase, which is the part of a trial that looks at whether the treatment seems to help the disease.[1] In this study, the efficacy phase is used to evaluate safety and tolerability for each treatment arm and to estimate the prostate-specific antigen (PSA) response rate.[1]

Study in selected solid tumors

Trial 2024-519563-18-00 is a Phase 4 study in people with breast cancer, ovarian cancer, and endometrial cancer.[2] The study is authorised and plans to enroll 294 participants.[2]

The title says this is a clinical study of MK-5684 in people with certain solid tumors, and Hydrocortisone appears among the listed interventions.[2] The brief summary says the study compares MK-5684 to standard of care, which means the usual treatment used in practice.[2]

The main endpoint is progression-free survival (PFS) for all cohorts, using RECIST 1.1 and blinded independent central review.[2] RECIST 1.1 is a standard way to measure whether tumors grow, shrink, or stay the same, and blinded independent central review means experts review the results without knowing which treatment each person received.[2]

Study in septic shock

Trial 2025-524122-18-00 is a Phase 3 randomized, controlled study in people with septic shock.[3] The study is authorised and plans to enroll 360 participants.[3]

The brief summary says the study evaluates dexmedetomidine as an adjunctive treatment for refractory septic shock in mechanically ventilated patients compared with standard care.[3] Hydrocortisone is listed among the interventions in this study at 200 mg by intravenous injection.[3]

The primary outcome is vital status at 30 days after randomization, which means whether the participant is alive 30 days after being assigned to a study group.[3] This is a direct survival measure and is important in a severe illness like septic shock.[3]

Outcomes and endpoints

The prostate cancer study measures dose-limiting toxicities, adverse events, treatment stops due to adverse events, and PSA response rate.[1] These endpoints help researchers understand both safety and early signs of benefit.[1]

The solid tumor study measures progression-free survival across all cohorts.[2] This endpoint shows how long participants live without the cancer getting worse.[2]

The septic shock study measures 30-day vital status.[3] This endpoint helps show whether the treatment plan may affect short-term survival in a critical care setting.[3]

What patients should know from the trial data

Based on the trial data, Hydrocortisone Acetate is being studied in very different diseases, so the purpose of each trial is not the same.[1][2][3] In one study it is part of early cancer research, in another it is part of a larger cancer comparison study, and in the third it appears in a septic shock trial.[1][2][3]

The studies are all authorised, but they are not the same type of trial or the same phase.[1][2][3] People who may join each trial depend on the condition being studied, such as mCRPC, selected solid tumors, or septic shock.[1][2][3]

Trial IDPhaseCondition studiedStatusEnrollment
NCT06353386Phase 1Metastatic castration resistant prostate cancer (mCRPC)Authorised311
2024-519563-18-00Phase 4Breast cancer, ovarian cancer, endometrial cancerAuthorised294
2025-524122-18-00Phase 3Septic shockAuthorised360

FAQ

  • What conditions are being studied in trials of Hydrocortisone Acetate? The trial data include advanced prostate cancer, selected solid tumors such as breast, ovarian, and endometrial cancer, and septic shock. These are very different conditions, so the studies are testing Hydrocortisone Acetate in different clinical settings.
  • Who may take part in these trials? The target groups are people with metastatic castration resistant prostate cancer, people with certain solid tumors, and people with septic shock. Each trial has its own eligibility rules, so participation depends on the condition and the study design.
  • What phases are the Hydrocortisone Acetate trials in? The trial data show Phase 1, Phase 3, and Phase 4 studies. This means the research includes early testing, larger studies that compare treatments, and studies that look at how a treatment works in a broader setting.
  • What are the trials trying to measure? The studies measure safety, tolerability, and treatment effect. Examples include dose-limiting toxicities, adverse events, prostate-specific antigen response rate, progression-free survival, and 30-day vital status.
  • Are these studies testing Hydrocortisone Acetate alone? No. In the trial data, Hydrocortisone Acetate is studied as part of treatment combinations or compared within broader study plans. The exact role of Hydrocortisone Acetate depends on the trial.

Ongoing Clinical Trials on Hydrocortisone Acetate

  • Study of MK-5684 compared to standard therapy in patients with breast cancer, ovarian cancer, or endometrial cancer

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Spain

  • Study of Opevesostat, Olaparib, and Cabazitaxel in Patients with Advanced Prostate Cancer

    Recruiting

    1 1 1
    Investigated drugs:
    Denmark Finland France Germany Ireland Italy +2

  • Study of dexmedetomidine and a drug combination for treating patients on mechanical ventilation with septic shock.

    Not yet recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    France

Glossary

  • Advanced prostate cancer: Prostate cancer that has spread or is harder to control than early-stage disease.
  • Metastatic castration resistant prostate cancer (mCRPC): A type of prostate cancer that has spread to other parts of the body and keeps growing even when hormones are lowered.
  • Solid tumor: A lump or mass made of cancer cells, such as breast, ovarian, or endometrial cancer.
  • Septic shock: A severe and life-threatening reaction to infection that can cause very low blood pressure and organ problems.
  • Interventional study: A trial where researchers assign a treatment or treatment plan and then watch what happens.
  • Phase 1: An early trial phase that mainly checks safety, tolerability, and the best dose or dose plan.
  • Phase 3: A larger trial phase that compares treatments and looks at whether one works better than another.
  • Phase 4: A later trial phase that studies a treatment in a broader group or in real-world use.
  • Dose-limiting toxicity (DLT): A side effect serious enough to limit how much of a treatment can be given.
  • Adverse event (AE): Any unwanted medical problem that happens during a study, whether or not it is caused by the treatment.
  • Progression-free survival (PFS): The length of time during and after treatment that the cancer does not get worse.
  • Prostate-specific antigen (PSA) response rate: The percent of participants whose PSA blood test improves in a way the study defines as a response.

References

  1. https://clinicaltrials.eu/trial/study-of-opevesostat-olaparib-and-cabazitaxel-in-patients-with-advanced-prostate-cancer/
  2. https://clinicaltrials.gov/study/2024-519563-18-00
  3. https://clinicaltrials.gov/study/2025-524122-18-00