OncoMatch/Clinical Trials/NCT06616155
Ruxolitinib and Enzalutamide for the Treatment of Metastatic Castration-Resistant Prostate Cancer
Is NCT06616155 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1/2 trial studies multiple treatments including Enzalutamide and Ruxolitinib for castration-resistant prostate carcinoma.
Treatment: Enzalutamide · Ruxolitinib — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Endocrine / hormonal
Cancer type
Prostate Cancer
Disease stage
Required: Stage IVB (AJCC v8)
Metastatic disease required
Stage IVB Prostate Cancer AJCC v8
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
Prior therapy
Must have received: androgen deprivation therapy
Surgical castration or continuous medical castration ≥ 8 weeks prior to screening; serum testosterone < 50 ng/dL
Must have received: abiraterone (abiraterone)
Have progressed on prior abiraterone treatment by Prostate Cancer Working Group 3 prostate specific antigen (PSA) criteria
Cannot have received: chemotherapy
Exception: docetaxel within the hormone sensitive setting is allowed
Have received chemotherapy in the metastatic castration-resistant setting (docetaxel within the hormone sensitive setting is allowed)
Lab requirements
Blood counts
Platelets ≥ 125,000/mm^3 (if CrCl 30-59, platelets > 150,000/mm^3); ANC ≥ 1500/mm^3; Hemoglobin ≥ 11 g/dL (no transfusions within 90 days prior to screening unless for acute bleeding)
Kidney function
Creatinine clearance (CrCl) ≥ 30 mL/min (Cockcroft and Gault equation)
Liver function
AST/ALT ≤ 3 x ULN (≤ 5 x ULN with liver metastasis); Bilirubin ≤ 1.5 x ULN OR direct bilirubin ≤ ULN for participants with total bilirubin levels > 1.5 x ULN; Gilbert's disease: bilirubin ≤ 3.0 mg/dL
Platelets ≥ 125,000/mm^3 (if CrCl 30-59, platelets > 150,000/mm^3); ANC ≥ 1500/mm^3; Hemoglobin ≥ 11 g/dL (no transfusions within 90 days prior to screening unless for acute bleeding); AST/ALT ≤ 3 x ULN (≤ 5 x ULN with liver metastasis); Bilirubin ≤ 1.5 x ULN OR direct bilirubin ≤ ULN for participants with total bilirubin levels > 1.5 x ULN; Gilbert's disease: bilirubin ≤ 3.0 mg/dL; Creatinine clearance (CrCl) ≥ 30 mL/min (Cockcroft and Gault equation)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Rush University · Chicago, Illinois
- University of Michigan Comprehensive Cancer Center · Ann Arbor, Michigan
- Karmanos Cancer Institute · Detroit, Michigan
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06616155 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior chemotherapy disqualifies patients from enrollment.
What disease stage is eligible?
Stage IVB is required (metastatic disease required).
Is this trial open to female patients?
No. This trial enrolls male patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages