Clinical trial · Interventional
Effect of Ruxolitinib on Tumor Infiltrating Myeloid Cells
An Exploratory proof-of Mechanism Study to Assess the Effect of Ruxolitinib on Tumor Infiltrating Myeloid Cells and Additional Immune Subsets in Prostate Cancer Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Recruitment difficulty due to eligibility criteria.
Summary
Brief summary (as posted)
Ruxolitinib will be dispensed to patients candidate to prostatectomy immediately after histological diagnosis of prostate adenocarcinoma. The treatment will be given for 28 days followed by a prostatectomy thereafter. Tumor material and blood samples will be analysed before, during and after the treatment with Ruxolitinib.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ruxolitinib 20 MG | Drug | Ruxolitinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Ruxolitinib
- description
- Oral administration of Ruxolitinib 20mg BID for 28 consecutive days
- interventionNames
- Drug: Ruxolitinib 20 MG
Primary outcomes (1)
- measure
- Tumor immune response
- timeFrame
- 9 wks
- description
- Tumor immune response modification induced by Ruxolitinib
Secondary outcomes (4)
- measure
- pSTAT3
- timeFrame
- 5 wks
- description
- Decrease of pSTAT3
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18-70 years * Histological diagnosis of prostate adenocarcinoma * Stage ≥T2b for which surgery is indicated * No distant metastasis (M0) * NLR ≥3 in the blood or NLR ≥3 in the tumor biopsies or a percentage of MDSCs ≥ 30% in the tumour biopsies * PS (ECOG scale) 0-1 * Adequate hepatic function: ALT and ASAT ≤ 2.5 x ULN, Bilirubin ≤ 1.5 ULN (exception if Gilbert's syndrome ≤ 2.5 x ULN) * Adequate renal function: calculated creatinine clearance ≥ 50 ml/min according to the formula of Cockcroft-Gault * Hemoglobin ≥ 10 g/dl, leukocyte count ≥ 4.0 x 103/µl, platelet count ≥ 200 x 103/µl * Informed Consent as documented by the patient's signature Exclusion Criteria: * No history of coagulation disorders and normal INR * Significant cardiovascular disorders in the last 12 months * Other clinically significant concomitant disease states which in the opinion of the Investigator may represent contraindications to study participation * Known or suspected non-compliance * Participation in another study with investigational drug within the 30 days preceding and during the present study * Ongoing treatment with strong CYP3A4 inhibitors or dual CYP2C9 and CYP3A4 inhibitors
References
Publications (0)
Data not yet available