Prostate CancerNCT03274778
Effect of Ruxolitinib on Tumor Infiltrating Myeloid Cells
A study testing Ruxolitinib 20 MG in people with Prostate Cancer, run by Oncology Institute of Southern Switzerland at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Ruxolitinib 20 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Sep 2017to 24 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Istituto Oncologico della Svizzera Italiana (IOSI)
Bellinzona, 6500
About this study
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
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.
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- Ruxolitinib 20 MG
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ruxolitinib 20 MGDrug
Also called Jakavi
tablets
| Study group | Role | What they receive |
|---|---|---|
| Ruxolitinib | Experimental | Oral administration of Ruxolitinib 20mg BID for 28 consecutive days Receives: Drug: Ruxolitinib 20 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor immune response
Tumor immune response modification induced by Ruxolitinib
Measured: 9 wks
Secondary outcomes (4)
pSTAT3
Decrease of pSTAT3
Measured: 5 wks
Cytokines
Reduction of cytokines associated to myeloid cells recruitment and tumor-promoting factors (e.g. IL8, IL6, TGF)
Measured: 6 wks
KI-67
Reduction by 50% of KI-67
Measured: 9 wks
biomarkers
Increase of senescence and apoptosis markers (p16, p21, Beta-galactosidase, Caspase-3, Caspase-8)
Measured: 5 wks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2017
- Study start1 Sep 2017
- Primary completion24 Mar 2020
- Study completion24 Mar 2020
Why it stopped: Recruitment difficulty due to eligibility criteria.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oncology Institute of Southern Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrea Alimonti, Prof., Study director, Institute of Oncology Research (IOR)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03274778
- Sponsor's protocol ID
- IOSI-IOR-001
- Status last verified
- Mar 2020
- First submitted
- 5 Sep 2017
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03274778
- Acronym / sponsor ID
- IOSI-IOR-001
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Recruitment difficulty due to eligibility criteria.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Oncology Institute of Southern SwitzerlandUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 24 Mar 2020 (actual)
- Study completion
- 24 Mar 2020 (actual)
- First posted
- 7 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ruxolitinib | Experimental | Drug: Ruxolitinib 20 MGOral administration of Ruxolitinib 20mg BID for 28 consecutive days |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ruxolitinib 20 MGAlso: Jakavitablets | Drug | Ruxolitinib |
Primary outcome
Tumor immune response
Time frame: 9 wks
Tumor immune response modification induced by Ruxolitinib
4 secondary outcomes
pSTAT3
Time frame: 5 wks
Cytokines
Time frame: 6 wks
KI-67
Time frame: 9 wks
biomarkers
Time frame: 5 wks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Alimonti, Prof. study director
Institute of Oncology Research (IOR)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ruxolitinib 20 MG in people with Prostate Cancer, run by Oncology Institute of Southern Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor immune response (time frame: 9 wks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.