Ebastine for Metastatic castration-resistant prostate cancer

Inclusion criteria

• {"criterion_text":"- 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)."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Signed informed consent obtained prior to initiation of any study-specific procedures or treatment"}
• {"criterion_text":"- Age ≥ 18 years"}
• {"criterion_text":"- Life expectancy ≥ 3 months"}
• {"criterion_text":"- Performance status 0 - 1"}
• {"criterion_text":"- 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 criteria

• {"criterion_text":"- 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"}
• {"criterion_text":"- 2. Presence of any serious concomitant systemic disorders and/or psychiatric condition incompatible with the study (at the investigator’s discretion)"}
• {"criterion_text":"- 3. Presence of any active infection (at the investigator’s discretion)."}
• {"criterion_text":"- 4. CNS disease including epilepsy or altered mental status precluding understanding of the informed consent process and/or completion of the necessary study procedures."}
• {"criterion_text":"- 5. Concurrent use of cationic amphiphilic drugs (see appendix A) including over-the-counter medication."}
• {"criterion_text":"- 6. Use of other investigational drug"}
• {"criterion_text":"- 7. Allergic reaction to any of the included drugs"}

Primary endpoints

• {"endpoint_text":"- Change in blood and urine Bis(monoacylglycero)phosphate (BMP)","definition_or_measurement_approach":""}

Secondary endpoints

• {"endpoint_text":"- • PSA response rate (≥ 50% decline in PSA compared to baseline according to PCWG3.)","definition_or_measurement_approach":"PSA response rate defined as ≥ 50% decline in PSA compared to baseline according to PCWG3."}
• {"endpoint_text":"- • Radiologic progression free survival (rPFS).","definition_or_measurement_approach":""}
• {"endpoint_text":"- • Time to PSA progression defined in accordance with PCWG3.","definition_or_measurement_approach":"Defined in accordance with PCWG3."}
• {"endpoint_text":"- • Toxicity in the combination of docetaxel and ebastine.","definition_or_measurement_approach":""}

Denmark

Earliest CTIS Part Ii Submission Date

03-12-2024

Latest Decision Or Authorization Date

22-08-2025

Processing Time Days

262

Number Of Sites

2

Number Of Participants

30

Primary sponsor

Full Name

Rigshospitalet

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Denmark

Third parties

• {"country":"Denmark","full_name":"Frederiksberg Hospital","duties_or_roles":"sponsorDuties code 1","organisation_type":"Hospital/Clinic/Other health care facility"}