Study on Golimumab and Apalutamide for Treating Castration-Resistant Prostate Cancer (TRAMP Study)

Sponsor: University of Washington

Sponsor score: 40

Inactive

ClinicalTrials ID:NCT05960578

This clinical trial is exploring the effectiveness of combining two drugs, golimumab and apalutamide, to treat prostate cancer that continues to grow despite hormone therapy. Golimumab helps reduce inflammation, while apalutamide blocks hormones that fuel cancer growth.

Patient Parameters

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Program Overview

This phase II study is testing how well the combination of golimumab and apalutamide works in patients with castration-resistant prostate cancer, which is a type of prostate cancer that keeps growing even when testosterone levels are low. Golimumab is a medication that reduces inflammation by blocking a substance in the body called TNF. Apalutamide is a medication that blocks male hormones to stop cancer cells from growing and spreading. The study aims to see if using both drugs together is more effective in treating this type of prostate cancer.

Description

In this study, patients will receive golimumab as an injection under the skin every four weeks for a total of six doses. They will also take apalutamide by mouth every day. Treatment with apalutamide will continue as long as the cancer does not worsen and side effects are manageable. Patients will have a tumor biopsy at the start and during the fourth cycle of treatment. They will also have CT or MRI scans, PSMA PET scans, and blood tests at the beginning, during the fourth cycle, and at the end of treatment. After finishing the study treatment, patients will have follow-up visits every three months.

Eligibility Criteria

Inclusion Criteria

Have a history of prostate cancer confirmed by lab tests.
Show signs of castration-resistant prostate cancer, such as rising PSA levels or cancer growth on scans, with low testosterone levels.
Have been treated with at least six months of hormone therapy, such as abiraterone or enzalutamide, in the past.
Show disease progression with rising PSA levels or cancer growth on scans after previous hormone therapy.
May have had chemotherapy in the past, but not within six months before joining the study.
Be 18 years or older.
Have a performance status score of 0 to 2, indicating full activity or some restriction in strenuous activities.
Have adequate blood counts and organ function as determined by specific blood tests.
Agree to use effective birth control methods during the study and for three months after the last dose.
Have no signs of active tuberculosis and a negative TB test before starting the study.
Agree to sign an informed consent form and understand the study procedures.

Exclusion Criteria

Have had chemotherapy for castration-resistant prostate cancer.
Have received more than six weeks of hormone therapy for castration-resistant prostate cancer.
Are taking other investigational drugs within 14 days before joining the study.
Have a type of prostate cancer with small cell or neuroendocrine features.
Have untreated or symptomatic brain metastases.
Have active hepatitis B or C infections.
Have impaired wound healing or recent major surgery.
Are taking other TNF inhibitors or certain medications for rheumatoid arthritis.
Have uncontrolled or serious illnesses, such as heart disease or infections.
Have a history of tuberculosis or certain immune deficiency syndromes.
Have a history of severe allergic reactions to similar drugs.
Have a transplanted organ, except for a corneal transplant done more than three months ago.
Have another type of cancer within the past five years, except for treated skin cancer.
Have a history of certain blood disorders or infections.
Have uncontrolled high blood pressure or gastrointestinal disorders affecting absorption.
Have a history of seizures or conditions that may lead to seizures.

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