Study Comparing Enoblituzumab to Standard Treatment in Men with High-Risk Localized Prostate Cancer

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT06014255

Provider View

This clinical trial is testing whether the drug enoblituzumab, given before prostate surgery, is effective in treating high-risk localized prostate cancer compared to standard treatments. Participants will be randomly assigned to receive either enoblituzumab or standard care for 12 weeks before surgery.

Patient Parameters

Program Overview

The purpose of this study is to see if the drug enoblituzumab, given before prostate surgery, can effectively treat high-risk localized prostate cancer. Men participating in the study will be randomly assigned to receive either enoblituzumab or standard treatment for 12 weeks before undergoing surgery to remove the prostate. The study will take place at several medical centers, including Harvard/Dana-Farber Cancer Centers and Mayo Clinic. Participants will have various tests and scans before and after treatment to monitor the cancer's response and any side effects. Follow-up visits will occur 30 and 90 days after surgery, and regular PSA tests will be conducted for up to three years.

Description

This study involves men with high-risk localized prostate cancer who will receive either the drug enoblituzumab or standard treatment before having their prostate surgically removed. The study aims to determine if enoblituzumab is effective in reducing the cancer compared to standard treatments. Participants will be recruited from several medical centers and will undergo a series of tests, including prostate biopsies and imaging scans, to assess their eligibility and monitor their progress.

Participants will be randomly assigned to receive enoblituzumab or standard care for 12 weeks before surgery. After the treatment period, the prostate will be removed, and the tissue will be examined to evaluate the treatment's effectiveness. Blood samples and other tests will be collected throughout the study to understand how the body responds to the treatment.

Follow-up evaluations will occur 30 and 90 days after surgery to check for any side effects. Participants will continue to be monitored by their doctors, with regular PSA tests every few months for up to three years to track any changes in their condition.

Eligibility Criteria

Inclusion Criteria

  • Men aged 18 years or older with a confirmed diagnosis of high-risk localized prostate cancer.
  • Cancer must not have spread to lymph nodes, bones, or other organs, as shown by scans.
  • Must have had a prostate biopsy within the last three months showing specific cancer characteristics.
  • Surgery to remove the prostate must be planned.
  • Must be in good overall health, with specific blood counts and organ function levels.
  • Must agree to use barrier contraception from the start of treatment until surgery.
  • Must be willing to provide informed consent and comply with study requirements.

Exclusion Criteria

  • Cancer has spread to lymph nodes or other parts of the body, except for specific small lymph node involvement.
  • Have other types of prostate cancer, such as small cell or neuroendocrine tumors.
  • Have received prior treatments like radiation, hormone therapy, or chemotherapy for prostate cancer.
  • Have used experimental treatments or immunotherapy for prostate cancer.
  • Are currently using certain medications like systemic corticosteroids or hormone therapies.
  • Have a history of autoimmune diseases requiring treatment.
  • Have had another cancer within the last three years, except for certain skin or bladder cancers.
  • Have uncontrolled infections or other serious health conditions.
  • Have a history of HIV or untreated hepatitis B/C.

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