Phase 2 Prostate Cancer Trial, Recruiting NCT06616155 Sponsor: University of Michigan Rogel Cancer Center Condition: Prostate Cancer
Back to Prostate Cancer

Phase 2 Prostate Cancer Trial, Recruiting

NCT06616155
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • Adult males aged 18 or older who have prostate cancer that has spread to other parts of the body, is no longer responding to hormone-lowering treatment, and has previously been confirmed as a specific type called adenocarcinoma.
  • People who have had their testosterone lowered to very low levels (below 50 ng/dL) either through surgery to remove the testicles or through ongoing hormone-blocking medications for at least 8 weeks before screening.
  • People whose cancer has continued to grow while on a drug called abiraterone, shown by rising PSA levels on two tests at least one week apart, with the most recent PSA above 2.0 ng/mL.
  • People who responded poorly to abiraterone — meaning they were on it for less than 12 months if treatment started during early hormone-sensitive disease, or less than 6 months if treatment started after the cancer became resistant to hormone therapy.
  • People whose most recent treatment is hormone-blocking therapy (ADT) combined with abiraterone, and who are able to sign consent within 30 days of stopping abiraterone (or before stopping it).
  • People who are willing to have a biopsy of a cancer deposit during the screening process, if one can be safely accessed.
  • People who meet certain thresholds for blood cell counts, liver function, kidney function, and other lab values, all measured within 28 days before starting treatment (confirm specific values with trial site).
  • People with a general health and activity level rated at 0, 1, or 2 on a standard medical scale, where a rating of 2 should be related to the cancer itself.
  • People who agree to use contraception during treatment and for at least 90 days after the last dose, with female partners of childbearing potential also using contraception during that period.
  • People who are able to understand and sign a written consent form, as assessed by the study doctor.

Who may not be able to join:

  • People who have cancer that has spread to the brain and has not been treated with radiation or surgery (previously treated and stable brain spread may be acceptable).
  • People who have a history of seizures, or who are known to be allergic to enzalutamide, ruxolitinib, or any of the ingredients in these medications.
  • People who are unable to swallow tablets or capsules, or who have digestive conditions that could affect how the study medications are absorbed.
  • People with poorly controlled high blood pressure (above 170/105 mmHg on two separate readings at the screening visit), unless the treating doctor has confirmed a condition called white coat hypertension.
  • People who have previously received chemotherapy for castration-resistant prostate cancer (note: docetaxel given during the earlier hormone-sensitive stage may be acceptable — confirm with trial site).
  • People who still have significant side effects from previous cancer treatments that have not settled back to mild or no symptoms (hair loss and nerve-related effects are exceptions).
  • People with active hepatitis B, hepatitis C, or active tuberculosis; people with latent tuberculosis are also excluded; people with well-controlled HIV may be considered, but all potential interactions between HIV medications and study drugs must be reviewed first.
  • People who have had a heart attack, stroke, blood clot in the lungs, or a deep vein blood clot within the 6 months before joining the study.
  • People whose treating doctor estimates they have less than 6 months to live.
  • People currently taking a medication called fluconazole (an antifungal drug).
  • People taking supplements that contain androgens (male hormones), or certain other medications that strongly affect how the body processes drugs, unless those medications can be safely stopped at least 7 days or 5 half-lives before starting treatment (whichever is longer) — confirm specific medications with trial site.
  • People considered to be at high risk of tuberculosis reactivation, such as those who have had close contact with someone with active tuberculosis or who have a personal history of active or latent tuberculosis.
  • People with underlying liver disease of any severity level as rated by a standard medical scoring system called Child-Pugh class A, B, or C.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 23 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Zachery R Reichert, University of Michigan Rogel Cancer Center

Phone: 1-800-865-1125

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
University of Michigan Rogel Cancer Center
Registry
ClinicalTrials.gov
Start date
1 June 2026
Est. completion
1 June 2028

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Dose-limiting toxicity (DLT); Maximum tolerated dose (MTD)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 23 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov