Effect of Ruxolitinib on Tumor Infiltrating Myeloid Cells

Prostate Cancer Clinical Trial

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

Status Withdrawn

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

• NCT number: NCT03274778
• Study type: Interventional
• Source: Oncology Institute of Southern Switzerland
• Status: Withdrawn
• Phase: N/A
• Start date: September 1, 2017
• Completion date: March 24, 2020