Using ebastine with docetaxel to treat advanced prostate cancer

Ebastine in Combination With Docetaxel as a Treatment for Castration-resistant Metastatic Prostate Cancer

This study is testing whether adding ebastine to the standard prostate cancer treatment with docetaxel can help men with advanced prostate cancer feel better and improve their health.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: Male
• Sponsor: Rigshospitalet, Denmark (Academic / other)
• Locations: 1 site (Copenhagen)
• Trial ID: NCT06480110 on ClinicalTrials.gov

What this trial studies

This open-label phase I/II study evaluates the effectiveness of adding ebastine to the standard treatment of docetaxel for patients with metastatic castration-resistant prostate cancer. Participants will be randomly assigned to receive either ebastine daily alongside docetaxel or docetaxel alone, with a maximum of 10 courses of treatment. The primary goal is to assess changes in urinary and blood lipid profiles to determine ebastine's absorption and potential efficacy, while secondary goals include monitoring PSA response and radiologic progression-free survival.

Who should consider this trial

Good fit: Ideal candidates are men with histologically confirmed metastatic castration-resistant prostate cancer who have shown disease progression after prior therapies.

Not a fit: Patients with pure small-cell or high-grade neuroendocrine prostate cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment combination could improve outcomes for patients with advanced prostate cancer.

How similar studies have performed: While the combination of ebastine with docetaxel is a novel approach, similar studies have shown promise in enhancing treatment efficacy for prostate cancer.

Eligibility criteria

Inclusion Criteria:

* 1\. Have a histologically confirmed adenocarcinoma or poorly differentiated carcinoma of the prostate (carcinomas with pure small-cell histology or pure high grade neuroendocrine histology are excluded; neuroendocrine differentiation is allowed).

  2\. Surgically or medically castrated, with serum testosterone levels of ≤ 50 ng/dL equivalent to 1.7 nmol/L. For patients, currently being treated with luteinizing hormone-releasing hormone (LHRH) agonists, i.e., patients who have not undergone an orchiectomy, therapy must be continued throughout the study.

  3\. Have evidence of disease progression after prior therapy for mCRPC:

Disease progression after initiation of most recent therapy is based on any of the following criteria:

* Rise in PSA: a minimum of 2 consecutive rising levels, with an interval of ≥ 1 week between each determination. The most recent screening measurement must have been ≥ 2 ng/mL
* Transaxial imaging: new or progressive soft tissue masses on CT or MRI scans as defined by RECIST 1.1
* Radionuclide bone scan: at least 2 new metastatic lesions 4. Signed informed consent obtained prior to initiation of any study-specific procedures or treatment 5. Age ≥ 18 years 6. Life expectancy ≥ 3 months 7. Performance status 0 - 1 8. Adequate organ functions

  1. Hematological: absolute neutrophil count (ANC) \>1.5 x 109/L, platelet count \>100 x 109/L, hemoglobin \> 6,2 mmol/L
  2. Hepatic: Bilirubin within normal range, aspartate transaminase (AST) and alanine transaminase (ALT) \<2.5 upper normal lever, albumin \> 25 g/L
  3. Renal: creatinine clearance \>30 mL/min/1.73m2

     Exclusion Criteria:

     \- 1. History of significant gastric or small bowel resection, malabsorption syndrome, or other lack of integrity of the upper gastrointestinal tract that may prevent compliance with oral drug administration 2. Presence of any serious concomitant systemic disorders and/or psychiatric condition incompatible with the study (at the investigator's discretion) 3. Presence of any active infection (at the investigator's discretion). 4. Central nervous system (CNS) disease including epilepsy or altered mental status precluding understanding of the informed consent process and/or completion of the necessary study procedures.

     5\. Concurrent use of cationic amphiphilic drugs (see appendix A) including over-the-counter medication.

     6\. Use of other investigational drug 7. Allergic reaction to any of the included drugs

Where this trial is running

Copenhagen

• Department of Oncology 5073, Rigshospitalet — Copenhagen, Denmark (Recruiting)

Study contacts

• Principal investigator: Helle Pappot, DMsc — Rigshospitalet, Denmark
• Study coordinator: Helle Pappot, DMsc

Conditions Metastatic Castration-resistant Prostate Cancer