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Metastatic Castration-Resistant Prostate CarcinomaPhase 2NCT05960578

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

A Phase 2 study testing Apalutamide, Biopsy and Biospecimen Collection in people with Metastatic Castration-Resistant Prostate Carcinoma and Prostate Adenocarcinoma, run by University of Washington at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Apalutamide, Biopsy and Biospecimen Collection
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
1 siteUnited States
Study dates
23 May 2024to 14 Apr 2026
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • History of histologically diagnosed prostatic adenocarcinoma
  • Participants must have progressed on no more than one novel hormonal therapy (NHT) by PSA or radiographic criteria (per Prostate Cancer Working Group 3 [PCWG3] or Response Evaluation Criteria in Solid Tumors [RECIST] version [v]1.1) and a castrate serum testosterone level (i.e., ≤ 50 ng/dL). If progressive disease by radiographic criteria, PSA must be ≥ 2ng/ml. PSA progression will be defined as at least two successive PSA rises above the nadir, separated by ≥ 1 week, with the last determination having a value of ≥ 2 ng/mL. NHTs include but are not limited to either abiraterone, enzalutamide, darolutamide, or apalutamide. (Biosimilar or generic agents may be allowed at the discretion of the principal investigator [PI].) Note: prior NHT exposure that did not result in disease progression will not be counted as prior line, i.e., patient's that completed prior abiraterone course in the localized setting, patients that changed NHT due to toxicity or financial toxicity
  • Participants must have previously progressed on a novel hormonal therapy (NHT) by PSA or radiographic criteria (per PCWG3 or RECIST v1.1). NHTs include but are not limited to either abiraterone, enzalutamide, darolutamide, or apalutamide. (Biosimilar or generic agents may be allowed at the discretion of the principal investigator [PI].) Note: prior NHT exposure that did not result in disease progression will not be counted as prior line, i.e., patient's that completed prior abiraterone course in the localized setting, patients that changed NHT due to toxicity or financial toxicity
  • Participants may have received one prior line of taxane chemotherapy in any setting
  • Participants must be >= 18 years of age prior to signing informed consent
  • Eastern Cooperative Oncology Group (ECOG) performance status score =< 2
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  • Hemoglobin >= 9.0 g/dL, independent of transfusion and/or growth factors within 3 months prior to randomization
  • Platelet count >= 100,000 x 10^9/uL independent of transfusion and/or growth factors within 3 months prior to randomization
  • Absolute neutrophil count >= 1.5 x 10^3/mL
  • Serum albumin >= 3.0 g/dL
  • Serum creatinine =< 1.5 mg/dL
  • Serum potassium >= 3.5 mmol/L
  • Serum total bilirubin < 1.5 x upper limit of normal (ULN) (Note: In subjects with Gilbert's syndrome, if total bilirubin is > 1.5 x ULN, measure direct and indirect bilirubin and if direct bilirubin is =< 1.5 x ULN, subject may be eligible)
  • Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase =< 1.5 x ULN
  • Agrees to use a condom (even men with vasectomies) and another effective method of birth control if he is having sex with a woman of childbearing potential or agrees to use a condom if he is having sex with a woman who is pregnant while on study drug and for 3 months following the last dose of study drug. Must also agree not to donate sperm during the study and for 3 months after receiving the last dose of study drug
  • Medications known to lower the seizure threshold (see list under prohibited meds) must be discontinued or substituted at least 4 weeks prior to study entry
  • Have had no known recent close contact with a person with active tuberculosis (TB) or, if there has been such contact, will be referred to a physician specializing in TB to undergo additional evaluation
  • Participants must sign an informed consent form (ICF) indicating that they understand the purpose of, and procedures required for, the study and are willing to participate in the study

Who cannot join

  • Subjects may not be receiving other investigational agents within 14 days prior to enrollment
  • Subjects with predominant small cell or neuroendocrine variant prostate cancer on most recent standard of care biopsy
  • Evidence of serious and/or unstable pre-existing medical, psychiatric or other condition that could interfere with patient safety
  • Symptomatic central nervous system (CNS) metastases. Treated CNS metastases will be allowed if these are stable for at least 8 weeks prior to enrollment
  • Uncontrolled or active infection, including:
  • Hepatitis B infection (acute or chronic) as defined according to the American Society of Clinical Oncology guidelines, or hepatitis C infection (anti-hepatitis C virus [HCV] antibody positive and HCV-ribonucleic acid [RNA] quantitation positive)
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  • Recent serious infection (e.g., requiring IV antibiotics or hospitalization within last two months)
  • Herpes zoster infection within 2 months of screening
  • History of active granulomatous infection, including histoplasmosis, or coccidioidomycosis
  • HIV (HIV antibody positive)
  • Active or untreated latent tuberculosis
  • History of infected joint prosthesis or received antibiotics for suspected infection of a joint prosthesis in the past five years, if that prosthesis has not been removed or replaced
  • Less serious infections (e.g., acute upper respiratory tract infection, simple urinary tract infection) need not be considered exclusionary at the discretion of the investigator
  • Has impaired wound healing capacity defined as current skin/decubitus ulcers, chronic leg ulcers, known gastric ulcers, or unhealed incisions
  • Major surgery within 2 weeks of the first dose, or will not have fully recovered from surgery, or has surgery planned during the time the subject is expected to participate in the study or within 2 weeks after the last dose of study drug administration (Note: subjects with planned surgical procedures to be conducted under local anesthesia may participate)
  • Co-administration of other TNF-alpha inhibitors or disease-modifying anti-rheumatic drugs (DMARDS) for the treatment of rheumatoid arthritis or other rheumatologic condition. (Note: prior exposure to TNF-alpha inhibitors is allowed for non-rheumatologic disease (e.g., SARS-CoV-2) if washout period > 5 half-lives prior to study enrollment)
  • Any other issue that would impair the ability of the subject to receive or tolerate the planned treatment at the investigational site, to understand informed consent or any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject (e.g., compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
  • Presence of significant cardiovascular disease including New York Heart Association (NYHA) class II-IV heart failure, uncontrolled arrhythmia, myocardial infarction (MI) or stroke within 6 months
  • History of autoimmune disorder, including multiple sclerosis or optic neuritis, lupus or lupus-like Syndrome
  • Hypersensitivity to any biologics or known allergies or clinically significant reactions to murine, chimeric, or human proteins, monoclonal antibodies (mAbs), or antibody fragments
  • Have a transplanted organ (with the exception of a corneal transplant performed > 3 months prior to first administration of study drug)
  • Currently has a malignancy or a history of malignancy within 3 years before screening (with the exception of prostate cancer, treated superficial bladder cancer, or a nonmelanoma skin cancer that has been adequately treated with no evidence of recurrence for at least 3 months prior to the administration of the first study intervention
  • Immune deficiency syndrome (e.g., severe combined immunodeficiency syndrome [SCIDS], T cell deficiency syndromes, B cell deficiency syndromes, and chronic granulomatous disease)
  • Have had a Bacille Calmette-Guerin (BCG) vaccination within 12 months of screening. Patients must agree not to receive BCG vaccination during the study and within 16 weeks after the last administration of study intervention
  • Known allergies, hypersensitivity, or intolerance to apalutamide or its excipients
  • Gastrointestinal disorder affecting absorption
  • History of seizure or any condition that in the opinion of the investigator may predispose to seizure or treatment with drugs known to lower the seizure threshold within 4 weeks prior to starting treatment with apalutamide

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Fred Hutch/University of Washington Cancer Consortium

    Seattle, Washington, 98109

Other trials in United States

About this study

Official title: TRAMP: Tumor Necrosis Factor- α Blockade and AR Inhibition in Men With CRPC

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.

Read the 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.

Being tested
Apalutamide, Biopsy, Biospecimen Collection, Computed Tomography, Golimumab
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ApalutamideDrug

    Also called ARN 509, ARN-509, ARN509, Erleada

    Given PO

  • BiopsyProcedure or surgery

    Also called BIOPSY_TYPE, Bx

    Undergo tumor biopsy

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection

    Undergo collection of blood samples

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo CT scan

  • GolimumabDrug

    Also called CNTO 148, Immunoglobulin G1, Anti-(Human Tumor Necrosis Factor Alpha) (Human Monoclonal CNTO 148 Gamma-1-Chain), Disulfide with Human Monoclonal CNTO 148 Kappa-Chain, Dimer

    Given SC

  • Magnetic Resonance ImagingProcedure or surgery

    Also called Magnetic Resonance, Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance

    Undergo MRI

  • PSMA PET ScanProcedure or surgery

    Also called Prostate-specific Membrane Antigen PET, PSMA PET, PSMA-Positron emission tomography

    Undergo PSMA PET

  • Bone ScanProcedure or surgery

    Also called Bone Scintigraphy

    Undergo bone scan

Study groups in NCT05960578
Study groupRoleWhat they receive
Treatment (golimumab, apalutamide)ExperimentalPatients 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.
Receives: Drug: Apalutamide; Procedure: Biopsy; Procedure: Biospecimen Collection; Procedure: Computed Tomography; Drug: Golimumab; Procedure: Magnetic Resonance Imaging; Procedure: PSMA PET Scan; Procedure: Bone Scan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Prostate Specific Antigen (PSA)50 Response Rate

    Defined by at least a 50% decline in PSA from baseline, in subjects with castrate resistant prostate cancer after combination treatment with TNF-alpha alpha blockade (golimumab) and AR antagonism (apalutamide).

    Measured: Up to 12 weeks

Secondary outcomes (6)

  1. Objective Response Rate

    Will determine objective response rate of measurable or evaluable disease as per Response Evaluation Criteria in Solid Tumors version 1.1 criteria for soft tissue metastases.

    Target Lesions were assessed as follows:

    CR: Disappearance of all target lesions. All pathological lymph nodes short axis reduced to <10 mm. PR: Decrease by ≥30% in the sum of diameters. PD: Increase by ≥20% in the sum of diameters with an absolute increase of ≥5 mm, or appearance of ≥1 new lesion. SD: Neither sufficient shrinkage for PR nor sufficient increase for PD.

    Non-Target Lesions were assessed as follows:

    CR: Disappearance of all non-target lesions, normalization of tumor markers, and all lymph nodes must be non-pathologic in size (<10 mm short axis). Non-CR/Non-PD: Persistence of ≥1 non-target lesion and/or maintenance of tumor marker level above the normal limits. Progressive Disease (PD): Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.

    Measured: Up to 14.5 months

  2. Radiographic Progression Free Survival (PFS)

    The duration of radiographic PFS (rPFS) will be calculated for all treated subjects with soft tissue and/or bone disease as the time from the first dose of IP to the first objective evidence of radiographic progression or death from any cause, whichever occurs first. Radiographic disease progression is defined as progressive disease by RECIST for soft tissue and PCWG3 for bone disease. The PFS will be estimated using the Kaplan-Meier method for the treated population.

    Measured: Up to 14.5 months

  3. PSA PFS

    The interval between enrollment and the date of documented PSA progression. Progression will be declared if patient has documented to have a testosterone less than 50 ng/dL. In cases where a testosterone level has not been obtained and patient has not had an orchiectomy, progressive disease will be deemed if patient had a documented rise in PSA on luteinizing hormone-releasing hormone analogue therapy. Progression free survival curves will be generated using Kaplan-Meier method.

    Measured: Up to 14 months

  4. PSA Doubling Time

    The rate of PSA doubling will be calculated from nadir to confirmed PSA progression after 2 subsequent rises 1 week apart using standard calculators

    Measured: Up to 14 months

  5. Time to Subsequent Antineoplastic Therapy

    The interval between enrollment and the date of documented initiation of next therapy.

    Measured: Up to 16 months

  6. Incidence of Adverse Events

    Assess the incidence and severity of adverse events according to the National Cancer Institute - Common Terminology Criteria for Adverse Events version 5.0.

    Measured: Up to 30 days after final receipt of golimumab and/or apalutamide (up to 15 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jul 2023
  2. Study start23 May 2024
  3. Primary completion29 Jul 2025
  4. Study completion14 Apr 2026

Why it stopped: The trial was ended sooner than expected due to a combination of factors, including slow accrual, lower than anticipated benefit to patients, and loss of funding from the study sponsor.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05960578
Sponsor's protocol ID
RG1123487
Other IDs
NCI-2023-04887, FHIRB0020135
Status last verified
Aug 2026
First submitted
10 Jul 2023
Last updated
19 Oct 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Apalutamide, Biopsy and Biospecimen Collection in people with Metastatic Castration-Resistant Prostate Carcinoma and Prostate Adenocarcinoma, run by University of Washington at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prostate Specific Antigen (PSA)50 Response Rate (time frame: Up to 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05960578.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.

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