The COSMYC Trial: Testing a New Treatment Approach for Advanced Prostate Cancer

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Sponsor score: 60

ClinicalTrials ID:NCT06922318

Provider View

This study is exploring whether a combination of testosterone and a drug called ZEN-3694, followed by another combination with enzalutamide, can help shrink tumors in prostate cancer patients whose cancer has become resistant to standard treatments.

Patient Parameters

Program Overview

The COSMYC Trial is investigating a new treatment strategy for prostate cancer that has stopped responding to traditional therapies. The study aims to see if starting with a combination of testosterone and ZEN-3694, and then switching to enzalutamide with ZEN-3694, can effectively reduce tumor size. Researchers are also interested in whether this sequence of treatments can make the drugs work better together.

Description

The main goals of this study are to see if using ZEN-3694 with high-dose testosterone (called BATZEN) can help patients with advanced prostate cancer live longer without the disease getting worse, compared to past results. Another goal is to find out if switching to ZEN-3694 with enzalutamide (called ZENZA) after the first treatment stops working can help control the disease better.

Patients with advanced prostate cancer that has spread and is not causing pain will receive these treatments in a specific order to see if it improves their condition. Eligible participants are those whose cancer has progressed after using certain other prostate cancer drugs. They will continue to receive hormone therapy to lower testosterone levels throughout the study. Each treatment cycle lasts 28 days.

Participants must have a confirmed diagnosis of prostate cancer and meet specific health criteria, including having a low testosterone level and evidence of cancer spread. They must also have tried other treatments without success. The study involves regular monitoring and may include biopsies to analyze tumor changes.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of prostate cancer.
  • Currently receiving hormone therapy to lower testosterone levels.
  • Have low testosterone levels as confirmed by a blood test.
  • Cancer must have spread to other parts of the body, as shown by scans.
  • Cancer must have progressed after using certain prostate cancer drugs.
  • Must have a PSA level of 1.0 ng/mL or higher.
  • Agree to provide tumor samples for analysis.
  • Previous treatments like vaccines, certain drugs, and radiation are allowed if enough time has passed since the last dose.
  • Must stop using certain prostate cancer drugs for at least two weeks before starting the study.
  • Must try to stop using prednisone before starting the study, unless symptoms require continued use.
  • Must have acceptable liver and kidney function based on blood tests.
  • Must have adequate blood cell counts.
  • Must understand and agree to the study requirements and sign a consent form.
  • Must agree to use effective birth control methods during the study and for three months after the last dose of study drugs.

Exclusion Criteria

  • Have pain from prostate cancer that requires opioid pain medication.
  • Have a performance status score of 3 or higher, indicating limited ability to carry out daily activities.
  • Need to use a catheter for urination due to prostate cancer or an enlarged prostate.
  • Have an active, uncontrolled infection.
  • Have a history of HIV/AIDS, unless certain conditions are met.
  • Have active hepatitis B or C, unless under control with treatment.
  • Have a mental or physical condition that affects the ability to consent or follow study requirements.
  • Are taking certain blood thinners, unless they can switch to an allowed medication.
  • Have had a blood clot in the past year that is not being treated.
  • Have high hematocrit levels, untreated sleep apnea, or uncontrolled heart failure.
  • Are allergic to sesame or cottonseed oil.
  • Have had major surgery within the past three weeks or have not fully recovered from surgery.
  • Have a history of seizures or conditions that increase seizure risk.

Locations

FACILITYZIPCITYSTATE
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center21205BaltimoreMaryland

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