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

Part of paid clinical trials in Seattle, Washington.

Sponsor
University of Washington
Study ID
NCT05960578
Phase
PHASE2
Status
Active Not Recruiting

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Apalutamide — DRUG
    Given PO
  • Biopsy — PROCEDURE
    Undergo tumor biopsy
  • Biospecimen Collection — PROCEDURE
    Undergo collection of blood samples
  • Computed Tomography — PROCEDURE
    Undergo CT scan
  • Golimumab — DRUG
    Given SC
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • PSMA PET Scan — PROCEDURE
    Undergo PSMA PET
  • Bone Scan — PROCEDURE
    Undergo bone scan

Study Details

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.

Key Dates

Start date
May 23, 2024
Status verified
Apr 2026
Primary completion
Jul 29, 2025
Completion
Apr 14, 2027

Study Design

Enrollment
8 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (golimumab, apalutamide)
    Patients receive golimumab SC every 4 weeks for 6 doses and apalutamide PO daily. Treatment with apalutamide continues in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy at baseline and during cycle 4. Patients also undergo CT scans or MRI, PSMA PET, bone scan, and collection of blood samples throughout the study.

Primary Outcome Measure

Prostate specific antigen (PSA)50 response rate [ Time Frame: Up to 12 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Fred Hutch/University of Washington Cancer ConsortiumSeattleWashington98109-

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By research site
Fred Hutch/University of Washington Cancer Consortium· Seattle, WA

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