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Golimumab and Apalutamide for the Treatment of Castration-Resistant Prostate Cancer, TRAMP Study

NCT05960578 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2026-04-14

No results posted yet for this study

Summary

This phase II trial tests how well golimumab and apalutamide work in treating patients with castration resistant prostate cancer. Golimumab is in a class of medications called tumor necrosis factor (TNF) inhibitors. It works by blocking the action of TNF, a substance in the body that causes inflammation. Apalutamide is in a class of medications called androgen receptor inhibitors. It works by blocking the effects of androgen (a male reproductive hormone) to stop the growth and spread of cancer cells. Giving golimumab and apalutamide may work better in treating patients with castration-resistant prostate cancer.

Conditions

  • Metastatic Castration-Resistant Prostate Carcinoma
  • Prostate Adenocarcinoma
  • Stage IV Prostate Cancer AJCC v8

Interventions

DRUG

Apalutamide

Given PO

PROCEDURE

Biopsy

Undergo tumor biopsy

PROCEDURE

Biospecimen Collection

Undergo collection of blood samples

PROCEDURE

Computed Tomography

Undergo CT scan

DRUG

Golimumab

Given SC

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

PROCEDURE

PSMA PET Scan

Undergo PSMA PET

PROCEDURE

Bone Scan

Undergo bone scan

Sponsors & Collaborators

Principal Investigators

  • Ruben Raychaudhuri, MD · Fred Hutch/University of Washington Cancer Consortium

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-23
Primary Completion
2025-07-29
Completion
2027-04-14
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05960578 on ClinicalTrials.gov