Using ebastine with docetaxel to treat advanced prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Department of Oncology 5073, Rigshospitalet
  Copenhagen, Denmark Recruiting

Study contacts

• Principal investigator: Helle Pappot, DMsc — Copenhagen University Hospital, Rigshospitalet
• Study coordinator: Helle Pappot, DMsc
• Email: helle.pappot@regionh.dk
• Phone: +4535458403

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• Dual-target PSMA/PSCA CAR-NK Therapy in Advanced Prostate Cancer

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.