Ebastine in combination with docetaxel or as a treatment for metastatic castration-resistant prostate cancer
Key facts
- Where
- Copenhagen Oe és Frederiksberg, DániaSee the 2 sites
- Phase
- 2. fázis
Where in Dánia
- RigshospitaletCopenhagen Oe, DániaTaking people
- Frederiksberg HospitalFrederiksberg, DániaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Rigshospitalet
- Trial code
- EU 2024-518035-11-01
- Record updated
- 2025. augusztus 22.
- Original description
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.Read full original descriptionShow less
Ebastine in combination with docetaxel or cabazitaxel as a treatment for metastatic castration-resistant prostate cancer
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.
Inclusion: 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.
Exclusion: 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.