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Castration-Resistant Prostate CarcinomaPhase 1/2NCT06616155

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

A Phase 1/2 study testing Biopsy, Biospecimen Collection and Bone Scan in people with Castration-Resistant Prostate Carcinoma and Metastatic Prostate Adenocarcinoma, run by University of Michigan Rogel Cancer Center at 3 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Biopsy, Biospecimen Collection and Bone Scan
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
3 sitesUnited States
Study dates
Jun 2026to Jun 2030
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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 cancer (HSPC) disease setting (abiraterone started within 4 months of starting continuous androgen deprivation therapy [ADT]): < 12 months duration on abiraterone
  • Abiraterone started in castration-resistant prostate cancer (CRPC) disease setting: < 6 months duration on abiraterone due to progression or failure to achieve PSA50 response while on therapy
  • The patient's current or most recent treatment is ADT and abiraterone. Participants must sign consent within 30 days of discontinuing abiraterone or prior to stopping abiraterone
  • Patients must be willing to undergo metastatic tumor biopsy during screening. If no metastatic lesion is safely accessible to tumor biopsy, this requirement will not be required
  • 50% of patients must have measurable disease by RECIST 1.1 criteria
  • Once 50% of total expected cohort has non-measurable disease, only patients with measurable disease by RECIST 1.1 criteria will be eligible. (Percentages with measurable disease are not relevant within dose escalation. Once dose expansion is started, those at expansion dose would be included in percentage evaluation.)
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2 (grade 2 ECOGs should be related to disease and thus potentially reversible)
  • A male participant must agree to use of contraception during the treatment period and for at least 90 days after the last dose of study drug. Female partners of male patients should also use contraception for 90 days after the last dose of study drug if they are of childbearing potential
  • Platelets ≥ 125,000/mm^3 (obtained within 28 days prior to starting study therapy) (if creatinine clearance [CrCl] is between 30-59, the platelet entry criteria is > 150,000/mm^3)
  • Absolute neutrophil count (ANC) ≥ 1500/mm^3 (obtained within 28 days prior to starting study therapy)
  • Hemoglobin ≥ 11 g/dL (obtained within 28 days prior to starting study therapy) No transfusions within 90 days prior to screening unless performed for acute bleeding
  • Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 3 x upper limit of normal (ULN) (obtained within 28 days prior to starting study therapy) For patients with known liver metastasis: (ALT) and aspartate aminotransferase (AST) ≤ 5 x ULN
  • Bilirubin ≤ 1.5 the upper limit of normal (ULN) OR direct bilirubin ≤ ULN for participants with total bilirubin levels > 1.5 x ULN. For subjects with known Gilbert's disease, bilirubin ≤ 3.0 mg/dL (obtained within 28 days prior to starting study therapy)
  • Creatinine clearance (CrCl) ≥ 30 mL/min (obtained within 28 days prior to starting study therapy) For creatinine clearance estimation, the Cockcroft and Gault equation should be used

Who cannot join

  • History of untreated (with radiotherapy and/or surgery) brain metastasis is not allowed (stable and treated metastases are allowed)
  • History of seizures or known hypersensitivity to enzalutamide, ruxolotinib or any of the excipients in the product
  • Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with the absorption of the study medications
  • Uncontrolled hypertension as indicated by systolic blood pressure (SBP) > 170 mmHg or diastolic blood pressure (DBP) > 105 mmHg on 2 consecutive measurements at screening visit unless known to have white coat hypertension syndrome
  • Have received chemotherapy in the metastatic castration-resistant setting (docetaxel within the hormone sensitive setting is allowed)
  • Failure to recover to grade 1 or lower toxicity related to prior systemic therapy (excluding alopecia and neuropathy) prior to study consent
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  • Current active infection with any of the following: hepatitis B, hepatitis C, active tuberculosis, latent tuberculosis. Patients with well controlled HIV are eligible however all drug interactions with HIV drug and study therapies have to be reviewed
  • History of myocardial infarction, stroke, pulmonary embolism or deep vein thrombosis within 6 months of study enrollment
  • Study physician estimates life expectancy less than 6 months or patient is unable to swallow medications
  • Patients currently taking fluconazole
  • Currently receiving supplements containing androgens or medications known to be strong inhibitors of CYP2C8, strong inducers (except enzalutamide) or strong inhibitors of CYP3A4 and substrates of CYP3A4, CYP2C9 and CYP2C19 with a narrow therapeutic window. If substitution is possible, strong inducers, inhibitors and substrates must be discontinued at least 7 days or 5 half-lives (which ever longer) prior to the first administration of enzalutamide
  • Due to risk of tuberculosis (TB) reactivation, patients deemed at high risk by treating provider (e.g., close contact with someone with active TB, history of active/latent TB) should be excluded
  • Those with underlying hepatic disease with a CHILD-PUGH class A, B or C impairment are excluded

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Cancer AnswerLine contact

1-800-865-1125

CancerAnswerLine@med.umich.edu

United States3 sites, 3 recruiting

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109

    Cancer AnswerLine, 800-865-1125, CancerAnswerLine@med.umich.edu

    Zachery R. Reichert

    Recruiting

  • Rush University

    Chicago, Illinois, 60612

    Thomas Westbrook, 312-942-3192, thomas_westbrook@rush.edu

    Thomas Westbrook

    Not yet recruiting

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

    Frank Cackowski, 313-576-8321, cackowskif@karmanos.org

    Frank Cackowski

    Not yet recruiting

Other trials in United States

About this study

Official title: 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

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.

Read the detailed description

06MAR2026 Amendment- Decreasing the total study accrual to 20 patients and edited design focusing on safety and smaller expansion. Secondary objectives updated to include response within 6 months.

Being tested
Biopsy, Biospecimen Collection, Bone Scan, Computed Tomography, Enzalutamide
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BiopsyProcedure or surgery

    Also called BIOPSY_TYPE, Bx

    Undergo tissue biopsy

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection

    Undergo blood sample collection

  • Bone ScanProcedure or surgery

    Also called Bone Scintigraphy

    Undergo bone scan

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo CT

  • EnzalutamideDrug

    Also called ASP9785, MDV 3100, MDV-3100, MDV3100

    Given PO

  • RuxolitinibDrug

    Also called INCB 018424, INCB-018424, INCB-18424, INCB18424

    Given PO

Study groups in NCT06616155
Study groupRoleWhat they receive
Treatment (ruxolitinib, enzalutamide)ExperimentalPatients 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.
Receives: Procedure: Biopsy; Procedure: Biospecimen Collection; Procedure: Bone Scan; Procedure: Computed Tomography; Drug: Enzalutamide; Drug: Ruxolitinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose-limiting toxicity (DLT)

    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 95% binomial confidence intervals.

    Measured: Up to 28 days

  2. Maximum tolerated dose (MTD)

    MTD will be defined based on the rate of drug-related grade 3-5 adverse events (AEs) experienced. MTD will be the highest dose level at which the probability of a subject experiencing a DLT during cycle 1 falls between 0.23 and 0.33.

    Measured: Up to 28 days

Secondary outcomes (1)

  1. Rate of response

    To assess rate of response by PSA50 and/or RECIST 1.1 criteria of ruxolitinib in combination with enzalutamide in patients with mCRPC within the first 6 months of therapy (PSA50 confirmation not required).

    Measured: Up to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Sep 2024
  2. Study startJun 2026 (estimated)
  3. Primary completionJun 2028 (estimated)
  4. Study completionJun 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06616155
Sponsor's protocol ID
UMCC 2023.109
Other IDs
NCI-2024-06533, HUM00249478
Status last verified
Apr 2026
First submitted
31 Aug 2024
Last updated
5 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Biopsy, Biospecimen Collection and Bone Scan in people with Castration-Resistant Prostate Carcinoma and Metastatic Prostate Adenocarcinoma, run by University of Michigan Rogel Cancer Center at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Cancer AnswerLine (1-800-865-1125, CancerAnswerLine@med.umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-limiting toxicity (DLT) (time frame: Up to 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06616155.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.

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