Actively Recruiting
Ruxolitinib and Enzalutamide for the Treatment of Metastatic Castration-Resistant Prostate Cancer
Led by University of Michigan Rogel Cancer Center · Updated on 2026-05-05
20
Participants Needed
3
Research Sites
208 weeks
Total Duration
On this page
Sponsors
U
University of Michigan Rogel Cancer Center
Lead Sponsor
I
Incyte Corporation
Collaborating Sponsor
AI-Summary
What this Trial Is About
This phase I/II tests the safety, side effects and best dose of ruxolitinib in combination with enzalutamide and how well it works in treating patients with prostate cancer that remains despite blocking hormone production (castration-resistant) and that has spread from where it first started to other places in the body (metastatic). Ruxolitinib, a kinase inhibitor, slows down the growth of the tumor by blocking the proteins, JAK1 and JAK2, tumors use to grow. Enzalutamide, an androgen receptor inhibitor, works by blocking the effects of androgen (a male reproductive hormone). This may help stop the growth and spread of tumor cells that need testosterone to grow. Giving ruxolitinib in combination with enzalutamide may be safe, tolerable, and/or effective in treating metastatic castration-resistant prostate cancer.
CONDITIONS
Official Title
Ruxolitinib and Enzalutamide for the Treatment of Metastatic Castration-Resistant Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male, age 18 years or older with progressive metastatic castration-resistant prostate cancer confirmed by adenocarcinoma histology
- Written informed consent and HIPAA authorization before registration
- Ability to understand and sign informed consent
- Surgical or continuous medical castration at least 8 weeks before screening with serum testosterone below 50 ng/dL
- Progression on prior abiraterone treatment based on PSA rise (two measurements at least 1 week apart) with most recent PSA above 2.0 ng/mL
- Poor response to abiraterone defined as less than 12 months duration if started in hormone-sensitive setting or less than 6 months in castration-resistant setting
- Current or most recent treatment includes androgen deprivation therapy and abiraterone; consent signed within 30 days of discontinuing abiraterone or before stopping it
- Willingness to undergo metastatic tumor biopsy during screening unless no safely accessible lesion
- At least 50% of patients must have measurable disease by RECIST 1.1 criteria
- ECOG performance status 0 to 2 (grade 2 related to disease and potentially reversible)
- Agree to use contraception during treatment and for 90 days after last dose; female partners of childbearing potential must also use contraception
- Platelets at least 125,000/mm3 (or above 150,000/mm3 if creatinine clearance between 30-59)
- Absolute neutrophil count at least 1500/mm3
- Hemoglobin at least 11 g/dL with no transfusions in 90 days unless for acute bleeding
- AST and ALT no more than 3 times upper limit of normal (5 times if liver metastasis)
- Bilirubin no more than 1.5 times upper limit of normal or direct bilirubin within normal limits; up to 3.0 mg/dL for Gilbert's disease
- Creatinine clearance at least 30 mL/min using Cockcroft and Gault equation
You will not qualify if you...
- Untreated brain metastasis (stable and treated allowed)
- History of seizures or known allergy to enzalutamide, ruxolitinib, or any product ingredients
- Inability to swallow oral medications or gastrointestinal disorders affecting absorption
- Uncontrolled hypertension with systolic over 170 mmHg or diastolic over 105 mmHg on two screenings unless white coat hypertension
- Prior chemotherapy for metastatic castration-resistant prostate cancer (docetaxel allowed in hormone-sensitive setting)
- Unresolved toxicity greater than grade 1 from prior systemic therapy (except hair loss and neuropathy)
- Active infection with hepatitis B, hepatitis C, active or latent tuberculosis; well-controlled HIV allowed with drug interaction review
- History of heart attack, stroke, pulmonary embolism, or deep vein thrombosis within 6 months
- Life expectancy less than 6 months or inability to swallow medications
- Current use of fluconazole
- Receiving androgen supplements or medications strongly affecting CYP2C8, CYP3A4, CYP2C9, or CYP2C19 enzyme activity unless stopped 7 days or 5 half-lives before starting enzalutamide
- High risk of tuberculosis reactivation as assessed by provider
- Underlying liver disease with CHILD-PUGH class A, B, or C impairment
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Rush University
Chicago, Illinois, United States, 60612
Not Yet Recruiting
2
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
3
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Not Yet Recruiting
Research Team
C
Cancer AnswerLine
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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