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Androgen Receptor Inhibitor
Apalutamide for Bladder Cancer
Phase 1
Waitlist Available
Led By Edward M Messing
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have had cross sectional imaging of the abdomen and pelvis (computed tomography [CT] or magnetic resonance imaging [MRI] with or without contrast) within 6 months prior to enrollment with no signs of upper tract urothelial cancer (UC), invasive, nor metastatic disease
Eastern Cooperative Oncology Group (ECOG) performance status =< 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 28 days
Awards & highlights
Study Summary
This trial is testing a medication to see if it stops the growth and spread of bladder cancer cells.
Who is the study for?
This trial is for biologic male adults with non-muscle invasive bladder cancer, who are in good health and have not had certain treatments or conditions that could interfere with the study. They must be able to sign consent, have no signs of advanced disease on recent scans, and agree to use contraception.Check my eligibility
What is being tested?
The trial is testing if Apalutamide affects a protein called EGFR in patients with non-muscle invasive bladder cancer. It includes biospecimen collection, questionnaires, surgery to remove the tumor from the bladder, and administration of Apalutamide.See study design
What are the potential side effects?
Apalutamide may cause side effects such as fatigue, high blood pressure, rash, diarrhea, weight loss and fractures. It can also affect liver function tests and might lead to falls or injuries.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My recent scans show no signs of cancer spread in my abdomen or pelvis.
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I am fully active and can carry on all pre-disease activities without restriction.
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I am a man and I am 18 years old or older.
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My bladder cancer is suspected to be non-muscle invasive, as confirmed by a specialist.
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I have been recently diagnosed with bladder cancer or it has come back.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 28 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 28 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The relative Epidermal Growth Factor Receptor (EGFR) expression level
Secondary outcome measures
AR expression in adjacent urothelium with EGFR expression in participants treated with and without apalutamide
Effect of apalutamide on EGFR expression
Toxicity of participants treated with and without apalutamide
Other outcome measures
AR and EGFR (and possibly phosphorylated EGFR [pEGFR]) staining levels
Analysis of fibroblast growth factor receptor 3 (FGFR3) in deoxyribonucleic acid (DNA)
Biopsy
+10 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: ARM 1 (apalutamide,TURBT)Experimental Treatment4 Interventions
Patients receive apalutamide PO QD on days 1-21. Patients undergo TURBT on day 21. Up to 28 days of treatment is permitted in the absence of unacceptable toxicity. Patients undergo blood specimen collection at baseline and at time of TURBT.
Group II: ARM 2 (TURBT)Active Control3 Interventions
Patients undergo TURBT on day 21. Patients undergo blood specimen collection at baseline and at time of TURBT.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 2
~1730
Apalutamide
2015
Completed Phase 2
~3310
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,933,073 Total Patients Enrolled
Edward M MessingPrincipal InvestigatorUniversity of Wisconsin, Madison
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your testosterone levels are at least 300 ng/dL.I have had radiation therapy to my pelvis, prostate, or rectum.I haven't taken hormone therapies or anti-hormone treatments in the last 6 months.I have one or more tumors.Your white blood cell count is too low.I am fully active and can carry on all pre-disease activities without restriction.I am a man willing to use effective birth control during the study.I am a man and I am 18 years old or older.I do not have any serious illnesses or social situations that would stop me from following the study's requirements.My recent scans show no signs of cancer spread in my abdomen or pelvis.I am not on medications that raise seizure risks or severe drug interactions with apalutamide.Your alanine aminotransferase (ALT) level in your blood is not more than two times the normal limit at the study site.I have had bladder cancer that spread into the muscle or other types of urinary cancer.Your thyroid stimulating hormone (TSH) levels are within the normal range for the hospital or clinic where you are being tested.My urine culture showed less than 50,000 colonies/cc, or I've been treated and tested negative off antibiotics.You had allergic reactions to similar medications as apalutamide in the past.My bladder cancer is suspected to be non-muscle invasive, as confirmed by a specialist.Your AST level in the blood is not more than twice the normal limit for the testing facility.Your bilirubin levels must be within a certain range, but if you have Gilbert's syndrome, there are different rules for measuring your bilirubin levels.I have been recently diagnosed with bladder cancer or it has come back.
Research Study Groups:
This trial has the following groups:- Group 1: ARM 2 (TURBT)
- Group 2: ARM 1 (apalutamide,TURBT)
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.
Are there plentiful medical centers conducting this experiment in the city?
"The medical investigation is currently running in 6 distinct locations, including Bethesda, Tucson and Los Angeles. To minimise travel needs, it's important to pick the closest site if you decide to participate."
Answered by AI
Has the FDA sanctioned Transurethral Resection of Bladder Tumor?
"Due to the preliminary nature of this trial, Transurethral Resection of Bladder Tumor is provisionally given a score of one on our safety scale. As it stands, there are limited data points which support its efficacy and security."
Answered by AI
Are there any open enrollment spots for this research at present?
"Clinicaltrials.gov confirms that, as of now, this medical trial is no longer seeking volunteers to participate. This research initiative was initially published on February 12th 2023 and last modified on September 2nd 2022. Nevertheless, there are currently 2729 other studies actively recruiting patients."
Answered by AI
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