Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT06616155 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Stage IVB Prostate Cancer AJCC v8 and Castration-Resistant Prostate Carcinoma, sponsored by University of Michigan Rogel Cancer Center.

Recruiting
Registry status
Phase 1
Development phase
39
Enrollment target
3
Study locations

NCT06616155: Recruiting Phase 1 study of Stage IVB Prostate Cancer AJCC v8 and Castration-Resistant Prostate Carcinoma, sponsored by University of Michigan Rogel Cancer Center.

NCT06616155 is a Phase 1 study of Stage IVB Prostate Cancer AJCC v8 and Castration-Resistant Prostate Carcinoma that is actively recruiting participants, run by University of Michigan Rogel Cancer Center. The registered enrollment target is 39 participants, below the 176-participant average among 45 other Stage IVB Prostate Cancer AJCC v8 trials with a reported enrollment target (78% lower). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT06616155, a Phase 1 study of Stage IVB Prostate Cancer AJCC v8 and Castration-Resistant Prostate Carcinoma, is actively recruiting participants, sponsored by University of Michigan Rogel Cancer Center.

RECRUITING
Registry status
Phase 1
Development phase
39 participants
Enrollment target
3
Study locations

Study 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.

Primary Outcome

DLT will be defined based on the rate of drug-related grade 3-5 adverse events (AEs) experienced. AEs will be assessed using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The proportion of patients at each dose level experiencing each grade level of toxicity will be described. To estimate the frequency and severity of AEs associated with treatment, the proportion of subjects encountering toxicity at each dose level will be reported with exact

Conditions Studied

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

Interventions

  • PROCEDURE Biospecimen Collection
  • PROCEDURE Computed Tomography
  • PROCEDURE Biopsy
  • PROCEDURE Bone Scan
  • DRUG Enzalutamide

Study Locations (3)

Michigan

  • University of Michigan Comprehensive Cancer Center - Ann Arbor
  • Karmanos Cancer Institute - Detroit

Illinois

  • Rush University - Chicago

Trial Details

FieldValue
Enrollment Target 39 participants
Start Date 2026-01-30
Est. Completion 2030-01-30
Phase Phase 1
University of Michigan Rogel Cancer Center

292 total trials

What NCT06616155 shows while recruiting

NCT06616155 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 176-participant average among 45 other Stage IVB Prostate Cancer AJCC v8 trials with a reported enrollment target (78% lower).

The record links to 3 conditions, with Stage IVB Prostate Cancer AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.

NCT06616155 reports a single indexed study location in Michigan, Illinois.

Frequently Asked Questions

What is clinical trial NCT06616155 about?

NCT06616155 is a clinical study titled "Ruxolitinib and Enzalutamide for the Treatment of Metastatic Castration-Resistant Prostate Cancer". 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 othe...

What is the current status of trial NCT06616155?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 39 participants. The study started on 2026-01-30. Estimated completion is 2030-01-30.

What conditions does trial NCT06616155 study?

This clinical trial studies the following conditions: Stage IVB Prostate Cancer AJCC v8, Castration-Resistant Prostate Carcinoma, Metastatic Prostate Adenocarcinoma.

What interventions are being tested in trial NCT06616155?

The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Biopsy (PROCEDURE), Bone Scan (PROCEDURE), Enzalutamide (DRUG).

Who is sponsoring clinical trial NCT06616155?

This trial is sponsored by University of Michigan Rogel Cancer Center, which has 292 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06616155 being conducted?

This trial has 3 study locations across Illinois, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Stage IVB Prostate Cancer AJCC v8

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06616155's enrollment target sits among peer trials

39 30th of 45 higher than 16 of 45 other Stage IVB Prostate Cancer AJCC v8 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Stage IVB Prostate Cancer AJCC v8 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT03465592 · 39 participants · Phase 1

    Trial of Nivolumab Following Partially Human Leukocyte Antigen (HLA) Mismatched BMT in Children & Adults With Sarcoma

  • NCT03961776 · 39 participants

    Monitoring Treatment Response With On-board DWI During Neo-adjuvant Chemo-radiation for Rectal Cancer Using Magnetic Resonance-guided-radiotherapy Systems

  • NCT04050280 · 39 participants · Phase 2

    CLAG-GO for Patients With Persistent, Relapsed or Refractory AML

  • NCT04190862 · 39 participants · Phase 1

    E-CEL UVEC as an Adjunct Cell Therapy for Treatment of Anal Fistulas

Similar registry start date

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

  • NCT07125183 · started 2026-12 · Phase 2

    Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma

  • NCT07292298 · started 2026-11 · Phase 2

    Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates

  • NCT04263285 · started 2026-10 · NA

    Treatment of Depression Post-SCI

More recruiting context for NCT06616155

Source: ClinicalTrials.gov NCT06616155, the US trial registry maintained by the National Library of Medicine. NCT06616155 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.