Working… Menu
Trial record 1 of 1 for:    NCT03274778
Previous Study | Return to List | Next Study

Effect of Ruxolitinib on Tumor Infiltrating Myeloid Cells

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03274778
Recruitment Status : Withdrawn (Recruitment difficulty due to eligibility criteria.)
First Posted : September 7, 2017
Last Update Posted : March 26, 2020
Information provided by (Responsible Party):
Andrea Alimonti, Oncology Institute of Southern Switzerland

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 prostatectomy thereafter.

Tumor material and blood samples will be analysed before, during and after the treatment with Ruxolitinib.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Ruxolitinib 20 MG Not Applicable

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 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : September 1, 2017
Actual Primary Completion Date : March 24, 2020
Actual Study Completion Date : March 24, 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Ruxolitinib
Oral administration of Ruxolitinib 20mg BID for 28 consecutive days
Drug: Ruxolitinib 20 MG
Other Name: Jakavi

Primary Outcome Measures :
  1. Tumor immune response [ Time Frame: 9 wks ]
    Tumor immune response modification induced by Ruxolitinib

Secondary Outcome Measures :
  1. pSTAT3 [ Time Frame: 5 wks ]
    Decrease of pSTAT3

  2. Cytokines [ Time Frame: 6 wks ]
    Reduction of cytokines associated to myeloid cells recruitment and tumor-promoting factors (e.g. IL8, IL6, TGF)

  3. KI-67 [ Time Frame: 9 wks ]
    Reduction by 50% of KI-67

  4. biomarkers [ Time Frame: 5 wks ]
    Increase of senescence and apoptosis markers (p16, p21, Beta-galactosidase, Caspase-3, Caspase-8)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03274778

Layout table for location information
Istituto Oncologico della Svizzera Italiana (IOSI)
Bellinzona, Switzerland, 6500
Sponsors and Collaborators
Oncology Institute of Southern Switzerland
Layout table for investigator information
Study Director: Andrea Alimonti, Prof. Institute of Oncology Research (IOR)
Layout table for additonal information
Responsible Party: Andrea Alimonti, Prof. dr. med., Oncology Institute of Southern Switzerland Identifier: NCT03274778    
Other Study ID Numbers: IOSI-IOR-001
First Posted: September 7, 2017    Key Record Dates
Last Update Posted: March 26, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases