Effect of Ruxolitinib on Tumor Infiltrating Myeloid Cells
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|ClinicalTrials.gov Identifier: NCT03274778|
Recruitment Status : Withdrawn (Recruitment difficulty due to eligibility criteria.)
First Posted : September 7, 2017
Last Update Posted : March 26, 2020
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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Oral administration of Ruxolitinib 20mg BID for 28 consecutive days
Drug: Ruxolitinib 20 MG
Other Name: Jakavi
- Tumor immune response [ Time Frame: 9 wks ]Tumor immune response modification induced by Ruxolitinib
- pSTAT3 [ Time Frame: 5 wks ]Decrease of pSTAT3
- Cytokines [ Time Frame: 6 wks ]Reduction of cytokines associated to myeloid cells recruitment and tumor-promoting factors (e.g. IL8, IL6, TGF)
- KI-67 [ Time Frame: 9 wks ]Reduction by 50% of KI-67
- biomarkers [ Time Frame: 5 wks ]Increase of senescence and apoptosis markers (p16, p21, Beta-galactosidase, Caspase-3, Caspase-8)
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 ClinicalTrials.gov identifier (NCT number): NCT03274778
|Istituto Oncologico della Svizzera Italiana (IOSI)|
|Bellinzona, Switzerland, 6500|
|Study Director:||Andrea Alimonti, Prof.||Institute of Oncology Research (IOR)|