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Androgen Receptor Inhibitor
Golimumab + Apalutamide for Prostate Cancer
Phase 2
Recruiting
Led By Jessica Hawley
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years
Awards & highlights
Study Summary
This trial tests how well two medications can treat prostate cancer that doesn't respond to hormone therapy. Golimumab and apalutamide block substances that cause inflammation and hormones that help cancer cells grow.
Who is the study for?
Men with castration-resistant prostate cancer who have tried hormone therapy for at least 6 months and show signs of disease progression. They must be over 18, understand the study, and agree to use contraception. Excluded are those with small cell or neuroendocrine prostate cancer, recent chemotherapy in the CRPC setting, certain infections like hepatitis B/C, major surgery within two weeks before the trial or planned during it.Check my eligibility
What is being tested?
The TRAMP study is testing golimumab (a TNF inhibitor that reduces inflammation) combined with apalutamide (an androgen receptor inhibitor that blocks male hormones) to see if they're effective against advanced prostate cancer resistant to standard hormonal treatments.See study design
What are the potential side effects?
Potential side effects include immune system reactions due to TNF inhibition which can cause organ inflammation, increased risk of infection; and from blocking androgens: fatigue, hot flashes, bone pain, cognitive changes, gastrointestinal issues.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Prostate specific antigen (PSA)50 response rate
Secondary outcome measures
Incidence of adverse events
Objective response rate
PSA Doubling Time
+3 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (golimumab, apalutamide)Experimental Treatment7 Interventions
Patients receive golimumab SC every 4 weeks for 6 doses and apalutamide PO daily. Treatment with apalutaminde 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, and collection of blood samples at baseline, during cycle 4, and at end of treatment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Golimumab
2014
Completed Phase 4
~3480
Computed Tomography
2017
Completed Phase 2
~2720
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Biospecimen Collection
2004
Completed Phase 2
~1700
PSMA PET Scan
2020
N/A
~10
Apalutamide
2015
Completed Phase 2
~3310
Biopsy
2014
Completed Phase 4
~1090
Find a Location
Who is running the clinical trial?
University of WashingtonLead Sponsor
1,741 Previous Clinical Trials
1,847,726 Total Patients Enrolled
18 Trials studying Prostate Cancer
8,244 Patients Enrolled for Prostate Cancer
Janssen Scientific Affairs, LLCIndustry Sponsor
159 Previous Clinical Trials
580,484 Total Patients Enrolled
11 Trials studying Prostate Cancer
1,343 Patients Enrolled for Prostate Cancer
Jessica HawleyPrincipal InvestigatorFred Hutch/University of Washington Cancer Consortium
1 Previous Clinical Trials
48 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have an immune deficiency or HIV.I have received chemotherapy for castration-resistant prostate cancer.I have a history of disorders related to my lymph nodes.I have had a seizure or condition that could lead to a seizure in the last 4 weeks.My latest biopsy shows I have a rare type of prostate cancer.I received a BCG vaccine in the last year.I have an active infection caused by granulomas.I am taking other medications for rheumatoid arthritis.My wounds heal slowly or poorly.I have had TB before the screening.I have not had lupus, sensitivity to biologics, organ transplants, or cancer in the last 5 years.My brain metastases have been stable for at least 8 weeks.My condition is worsening and not under control.I have been diagnosed with prostate cancer through a tissue examination.I have not had major surgery in the last 2 weeks and do not plan any during the study.I have not had any heart problems in the last 3 months.I haven't had a serious infection or been hospitalized for one in the last 2 months.I do not have symptoms that suggest I have tuberculosis.I have an infection caused by nontuberculous mycobacteria or another opportunistic infection.My high blood pressure is not under control.My prostate cancer has worsened after the last treatment.I had chemotherapy for hormone-sensitive cancer more than 6 months ago.I am 18 years old or older.I have received more than 6 weeks of hormone therapy for prostate cancer.I have hepatitis B or C.My prostate cancer is growing despite low testosterone levels.I stopped taking seizure-risk increasing meds 4 weeks ago.My recent chest X-ray showed no signs of active tuberculosis.I have been diagnosed with or have a history of heart failure.I have not had any serious illnesses in the last 6 months.I have been treated with a new hormone therapy for at least 6 months.I have a digestive condition that affects how my body absorbs food.I can take care of myself and am up and about more than 50% of my waking hours.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (golimumab, apalutamide)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA endorsed golimumab and apalutamide as viable remedies?
"Despite being at Phase 2, golimumab and apalutamide have some evidence of safety; thus, our team assigned the drug combination a score of two."
Answered by AI
Is it still possible to join this investigation as a participant?
"According to clinicaltrials.gov, this medical investigation has ceased recruitment of patients as of July 20th, 2023. Although applicants are no longer being accepted for this trial, there are still 1,997 other studies that actively require participants."
Answered by AI
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