Trials / Active Not Recruiting
Active Not RecruitingNCT05960578
Golimumab and Apalutamide for the Treatment of Castration-Resistant Prostate Cancer, TRAMP Study
TRAMP: Tumor Necrosis Factor- α Blockade and AR Inhibition in Men With CRPC
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 8 (actual)
- Sponsor
- University of Washington · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
OUTLINE: Patients receive golimumab subcutaneously (SC) every 4 weeks for 6 doses and apalutamide orally (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 computed tomography (CT) scans or magnetic resonance imaging (MRI), prostate-specific membrane antigen (PSMA) positron emission tomography (PET), bone scan, and collection of blood samples throughout the study. After completion of study treatment, patients are followed every 3 months.
Conditions
- Metastatic Castration-Resistant Prostate Carcinoma
- Prostate Adenocarcinoma
- Stage IV Prostate Cancer AJCC v8
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2024-05-23
- Primary completion
- 2025-07-29
- Completion
- 2027-04-14
- First posted
- 2023-07-27
- Last updated
- 2026-04-14
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05960578. Inclusion in this directory is not an endorsement.