2024-518035-11-01RecruitingPhase 2
Ebastine in combination with docetaxel or as a treatment for metastatic castration-resistant prostate cancer
Ebastine in combination with docetaxel or cabazitaxel as a treatment for metastatic castration-resistant prostate cancer
Source: EU CTIS (euclinicaltrials.eu) · Last updated 22 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This is a randomized phase II trial to evaluate biomarkers (Bis(monoacylglycero)phosphate (BMP)) and PSA response rates after combining either docetaxel and ebastine or cabazitaxel and ebastine in castration resistant prostate cancer.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 18 Nov 2024
- Start date
- 2 Jun 2024
- Lead sponsor
- Rigshospitalet
- Diseases
- Prostate cancer
- EU CT number
- 2024-518035-11-01
- EudraCT number
- 2019-004259-35
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 30
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for men with prostate cancer that has spread and no longer responds to hormone-lowering treatment. Their cancer must have grown after earlier treatment.
- Age
- 18 years or older
- Sex
- Men only
- Disease stage
- Prostate cancer that has spread (metastatic) and keeps growing despite castration (mCRPC). Adenocarcinoma or poorly differentiated carcinoma. Pure small-cell or pure high-grade neuroendocrine cancer cannot join. Disease must have progressed after earlier treatment for mCRPC.
- Earlier treatment
- Surgically or medically castrated, with testosterone of 50 ng/dL or lower (1.7 nmol/L). Men on LHRH agonist treatment must keep taking it during the study. Cancer must have progressed after earlier mCRPC treatment.
- Biomarker or test result
- Progression shown by at least 2 rising PSA levels at least 1 week apart (latest 2 ng/mL or higher), or new or growing tumours on CT or MRI scans, or at least 2 new bone lesions on a bone scan.
Main reasons for not taking part
- Past major stomach or small bowel surgery, or a gut problem that stops swallowed medicine from working
- Serious other illness, mental health condition or active infection that does not fit the trial (investigator decides)
- Brain or nervous system disease, including epilepsy, that stops understanding consent or taking part
- Current use of cationic amphiphilic drugs, including over-the-counter ones
- Use of another investigational drug, or allergy to any of the trial drugs
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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. 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
Who the study is looking for
- 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 a. Hematological: absolute neutrophil count (ANC) >1.5 x 109/L, platelet count >100 x 109/L, hemoglobin > 6,2 mmol/L b. Hepatic: Bilirubin within normal range, aspartate transaminase (AST) and alanine transaminase (ALT) <2.5 UNL, albumin > 25 g/L c. Renal: creatinine clearance >30 mL/min/1.73m2
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Rigshospitalet | Copenhagen Oe | Denmark | Recruiting |
| Frederiksberg Hospital | Frederiksberg | Denmark | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.