Study on Enzalutamide and M9241 for Recurrent Prostate Cancer Without Lowering Testosterone

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06096870

Provider View

This clinical trial is testing the effectiveness of enzalutamide, alone and combined with M9241, in treating prostate cancer that has returned after initial treatment, without lowering testosterone levels.

Patient Parameters

Program Overview

Prostate cancer can return after treatment in many people each year, and there is no clear best way to treat it. This study aims to test the drug enzalutamide, both alone and with another drug called M9241, in people whose prostate cancer has come back after treatment. Participants will be adults aged 18 and older with recurrent prostate cancer. They will undergo screening, including physical exams, blood tests, and imaging scans. Treatment will be given in 4-week cycles, with enzalutamide taken daily as a pill and M9241 injected monthly. Participants will visit the clinic monthly for tests and will be monitored for up to 5 years after treatment.

Description

Enzalutamide is approved for treating metastatic prostate cancer when combined with testosterone-lowering therapy. However, this study explores its use without lowering testosterone, as it has shown promise in controlling prostate-specific antigen (PSA) levels in recurrent prostate cancer. Enzalutamide is well tolerated and can enhance immune cells that fight cancer. M9241 is an immunotherapy that targets tumor areas and has shown potential in enhancing immune responses and controlling PSA levels. This study will test if combining enzalutamide with M9241 can improve outcomes in recurrent prostate cancer. Participants will be randomly assigned to receive either enzalutamide alone or with M9241 for three cycles. If PSA levels return to baseline, some may receive additional enzalutamide treatment. The study will monitor PSA suppression duration and overall treatment effects.

Eligibility Criteria

Inclusion Criteria

  • Must have confirmed prostate cancer diagnosis or rising PSA levels with a history consistent with prostate cancer.
  • Previously treated for prostate cancer with surgery or radiation.
  • PSA doubling time of less than 12 months.
  • Testosterone levels above 100 ng/dL.
  • Aged 18 years or older.
  • Evidence of prostate cancer on PSMA PET/CT scan.
  • Good overall health with an ECOG performance status of less than 2.
  • Must agree to use effective contraception during and after treatment.
  • Adequate organ and marrow function, including specific blood cell counts and liver/kidney function.
  • Can enroll if hepatitis B, C, or HIV is under control.
  • Must be able to swallow pills and understand the study consent form.

Exclusion Criteria

  • Evidence of soft tissue disease on imaging scans.
  • Evidence of bone lesions on bone scans.
  • Allergic reactions to similar drugs or imaging agents.
  • Medical conditions requiring long-term steroid or immunosuppressive therapy.
  • History of seizures in the past 10 years.
  • Use of certain medications affecting drug metabolism before the study.
  • Active cancer within the past 3 years, except for certain skin or superficial cancers.
  • Uncontrolled illnesses that would interfere with study participation.

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