Study on M9241 and Docetaxel for Men with Advanced Prostate Cancer

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04633252

Provider View

This clinical trial is testing a new combination of treatments, M9241 and docetaxel, to see if it is safe and effective for men with prostate cancer that has spread and is either sensitive or resistant to hormone therapy.

Patient Parameters

Program Overview

This study is exploring whether combining the drug M9241 with docetaxel can safely and effectively treat prostate cancer that has spread to other parts of the body. The trial is open to men aged 18 and older who have either metastatic castration-sensitive prostate cancer (mCSPC) or metastatic castration-resistant prostate cancer (mCRPC). Participants will undergo various tests and receive treatment in cycles, with regular follow-up visits to monitor their health and the treatment's effects.

Description

This clinical trial is investigating a new treatment approach for men with advanced prostate cancer that has spread beyond the prostate. The study focuses on two types of prostate cancer: metastatic castration-sensitive prostate cancer (mCSPC) and metastatic castration-resistant prostate cancer (mCRPC). Researchers are testing whether adding a drug called M9241 to the standard treatment with docetaxel can improve outcomes for these patients.

Participants will be screened with medical tests, including blood and urine tests, heart evaluations, and imaging scans to check for cancer spread. They may also have tumor biopsies. The treatment will be given in cycles, each lasting 21 days. During each cycle, participants will receive docetaxel through an IV and M9241 as an injection under the skin.

Men with mCSPC will receive up to 6 cycles of treatment, while those with mCRPC will continue until they can no longer tolerate the side effects or their cancer worsens. After completing treatment, participants will have a follow-up visit 30 days later, and those with mCSPC will continue with follow-up visits every 3 months.

The study aims to determine if this combination of treatments is safe and can effectively delay the progression of prostate cancer. Researchers will also evaluate the impact of the treatment on prostate-specific antigen (PSA) levels and progression-free survival.

Eligibility Criteria

Inclusion Criteria

  • Men aged 18 years or older.
  • Confirmed diagnosis of prostate cancer, with evidence of cancer spread to other parts of the body.
  • For mCSPC participants: Must be within 134 days of starting hormone therapy (ADT).
  • For mCRPC participants: Must have been previously treated with hormone therapy and modern anti-androgens like abiraterone or enzalutamide.
  • Must not have had cancer progression while on docetaxel for mCSPC or within 3 months of completing it.
  • Must have adequate organ and bone marrow function, as determined by specific blood tests.
  • Must agree to use effective contraception during the study and for 4 months after the last dose of treatment.
  • Must be able to understand and sign a written informed consent document.
  • Participants with prior immune checkpoint therapy may be eligible upon the investigator's discretion.

Exclusion Criteria

  • Immunocompromised status due to conditions like HIV or active autoimmune diseases.
  • Serious medical illnesses that could interfere with the treatment.
  • Current use of medications that affect PSA levels or certain other medications.
  • Recent use of investigational drugs or live vaccines.
  • Positive for Hepatitis B or C.
  • Uncontrolled high blood pressure.
  • Prior treatment with docetaxel for mCRPC.
  • mCSPC participants who did not start abiraterone within 6 weeks of ADT or had any docetaxel.
  • History of allergic reactions to similar drugs used in the study.
  • Evidence of another active cancer within the past 3 years, except for certain skin cancers or bladder carcinoma in situ.
  • Active brain metastases or epidural disease.
  • Significant nerve damage (grade 2 or higher) at the start of the study.

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