Ruxolitinib and Enzalutamide for the Treatment of Metastatic Castration-Resistant Prostate Cancer

Part of paid clinical trials in Chicago, Illinois.

Sponsor
University of Michigan Rogel Cancer Center
Study ID
NCT06616155
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Castration-Resistant Prostate Carcinoma
  • Metastatic Prostate Adenocarcinoma
  • Stage IVB Prostate Cancer AJCC v8

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biopsy — PROCEDURE
    Undergo tissue biopsy
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Bone Scan — PROCEDURE
    Undergo bone scan
  • Computed Tomography — PROCEDURE
    Undergo CT
  • Enzalutamide — DRUG
    Given PO
  • Ruxolitinib — DRUG
    Given PO

Study Details

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.

Key Dates

Start date
Jun 30, 2026
Status verified
Apr 2026
Primary completion
Jun 30, 2028
Completion
Jun 30, 2030

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (ruxolitinib, enzalutamide)
    Patients receive ruxolitinib PO BID and enzalutamide PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection, CT and bone scan throughout the study. Patients may also undergo a tissue biopsy on study.

Primary Outcome Measure

Dose-limiting toxicity (DLT) [ Time Frame: Up to 28 days ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Rush UniversityChicagoIllinois60612
Thomas Westbrook
[email protected]
312-942-3192
Thomas Westbrook (PRINCIPAL_INVESTIGATOR)
University of Michigan Comprehensive Cancer CenterAnn ArborMichigan48109
Cancer AnswerLine
[email protected]
800-865-1125
Zachery R. Reichert (PRINCIPAL_INVESTIGATOR)
Karmanos Cancer InstituteDetroitMichigan48201
Frank Cackowski
[email protected]
313-576-8321
Frank Cackowski (PRINCIPAL_INVESTIGATOR)

Find similar trials in Chicago, IL

By research site
Rush University· Chicago, ILUniversity of Michigan Comprehensive Cancer Center· Ann Arbor, MIKarmanos Cancer Institute· Detroit, MI

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