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NCT06616155PHASE1, PHASE2RECRUITING

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

Sponsor: University of Michigan Rogel Cancer Center + Incyte Corporation

No open prediction endpoints

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Key Facts

Study type
INTERVENTIONAL
Conditions
Castration-Resistant Prostate Carcinoma, Metastatic Prostate Adenocarcinoma, Stage IVB Prostate Cancer AJCC v8
Interventions
Biopsy, Biospecimen Collection, Bone Scan, Computed Tomography
Enrollment
20 participants
Primary completion
Jun 2028
Study completion
Jun 2030
First posted
Sep 2024
Last updated
May 2026

Primary Endpoints (CT.gov)

Dose-limiting toxicity (DLT)

Time frame: Up to 28 days

Maximum tolerated dose (MTD)

Time frame: Up to 28 days

Secondary Endpoints

Rate of response

Eligibility Criteria

Inclusion Criteria: * Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information prior to registration * Males age ≥ 18 years with progressive metastatic, castration-resistant prostate cancer, previous adenocarcinoma histology confirmation required * Ability to understand a written informed consent document, as determined by the study physician or designee * Surgical castration or continuous medical castration ≥ 8 weeks prior to screening; serum testosterone \< 50 ng/dL * Have progressed on prior abiraterone treatment by Prostate Cancer Working Group 3 prostate specific antigen (PSA) criteria * PSA must rise on two measurements at least 1 week apart in order to be eligible. Refer to PCWG3 for clarification. * Most Recent absolute PSA must be \> 2.0 ng/mL * Patient meets definition of poor responder to abiraterone by one of the following: * Abiraterone started in hormone-sensitive prostate ca

Read full criteria on CT.gov →

✦ Analyst Commentary

Expert commentary on why this trial matters and what to watch for.

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Source

Open on ClinicalTrials.gov