Effect of Ruxolitinib on Tumor Infiltrating Myeloid Cells

Oncology Institute of Southern Switzerland (IOSI)

Status

Withdrawn

Conditions

Prostate Cancer

Treatments

Drug: Ruxolitinib 20 MG

Study type

Interventional

Funder types

Other

Identifiers

NCT03274778

IOSI-IOR-001

Details and patient eligibility

About

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.

Full description

Patients with suspected localized prostate cancer will undergo biopsies spotting different prostate sites, as per standard clinical practice. Patients with histologically confirmed prostate adenocarcinoma and candidate for prostatectomy, after signing the Informed Consent Form, will receive Ruxolitinib for 4 weeks (the time normally elapsing between histological diagnosis and surgery) and will thereafter undergo prostatectomy.

Remaining biological material from the diagnosis and the prostatectomy will be sent to the Molecular Oncology Laboratory for molecular analysis.

In addition, blood samples will be drawn before, during Ruxolitinib treatment (Week 2), at the end of treatment (Week 4), and after prostatectomy (Week 5), to assess the frequency and subtype of immune subsets and the circulating levels of cytokines and secreted.

Patients will be monitored for occurrence of adverse events/surgical complications during treatment and up to 4 weeks after the intervention.

Sex

Male

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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