Status:
WITHDRAWN
Effect of Ruxolitinib on Tumor Infiltrating Myeloid Cells
Lead Sponsor:
Oncology Institute of Southern Switzerland
Conditions:
Prostate Cancer
Eligibility:
MALE
18-70 years
Phase:
NA
Brief Summary
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 prostate...
Detailed Description
Patients with suspected localized prostate cancer will undergo biopsies spotting different prostate sites, as per standard clinical practice. Patients with histologically confirmed prostate adenocarci...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 24 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03274778
Start Date
September 1 2017
End Date
March 24 2020
Last Update
November 18 2025
Active Locations (1)
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1
Istituto Oncologico della Svizzera Italiana (IOSI)
Bellinzona, Switzerland, 6500