Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
MALE
NCT06480110

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

Led by Rigshospitalet, Denmark · Updated on 2025-04-13

30

Participants Needed

1

Research Sites

179 weeks

Total Duration

On this page

Sponsors

R

Rigshospitalet, Denmark

Lead Sponsor

D

Danish Cancer Society

Collaborating Sponsor

AI-Summary

What this Trial Is About

This is an open-label phase I/II study evaluating the addition of ebastine to docetaxel in the treatment for metastatic castration resistant prostate cancer. Patients will be randomized in a 2:1 fashion to receive ebastine daily during and after treatment with a maximum of 10 courses of docetaxel. The primary endpoint is change in the profile of urinary and blood lipids to indicate absorption and possible efficacy of ebastine. Secondary endpoints include PSA response and radiologic progression free survival.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Have histologically confirmed adenocarcinoma or poorly differentiated carcinoma of the prostate (excluding pure small-cell or pure high-grade neuroendocrine carcinoma; neuroendocrine differentiation is allowed)
  • Surgically or medically castrated with serum testosterone 3 50 ng/dL (1.7 nmol/L); patients on LHRH agonists must continue therapy throughout the study
  • Evidence of disease progression after prior therapy for metastatic castration-resistant prostate cancer, defined by rising PSA levels, new or progressive soft tissue masses on imaging, or at least 2 new bone metastases
  • Signed informed consent before any study procedures or treatment
  • Age 18 years or older
  • Life expectancy of at least 3 months
  • Performance status of 0 or 1
  • Adequate organ function: neutrophil count >1.5 x 10^9/L, platelet count >100 x 10^9/L, hemoglobin >6.2 mmol/L; bilirubin normal, AST and ALT <2.5 times upper limit, albumin >25 g/L; creatinine clearance >30 mL/min/1.73m2
Not Eligible

You will not qualify if you...

  • History of significant gastric or small bowel resection, malabsorption syndrome, or other upper gastrointestinal conditions preventing oral drug compliance
  • Serious systemic disorders or psychiatric conditions incompatible with the study
  • Active infections
  • Central nervous system diseases including epilepsy or altered mental status preventing informed consent or study completion
  • Concurrent use of cationic amphiphilic drugs including over-the-counter medications
  • Use of other investigational drugs
  • Allergic reactions to any of the study drugs

AI-Screening

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Trial Site Locations

Total: 1 location

1

Department of Oncology 5073, Rigshospitalet

Copenhagen, Denmark, 2100

Actively Recruiting

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Research Team

H

Helle Pappot, DMsc

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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