NCT06616155

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

Study of JAK Inhibition in Stem-Like Prostate Cancer (JASPER): A Phase 1b/2a Multicenter Study of Ruxolitinib and Enzalutamide in Castration Resistant Prostate Cancer

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 39 (estimated)
• Sponsor: University of Michigan Rogel Cancer Center · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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

Interventions

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

Timeline

• Start date: 2026-06-01
• Primary completion: 2028-06-01
• Completion: 2030-06-01
• First posted: 2024-09-27
• Last updated: 2026-04-13

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study