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New treatment option for Non-Muscle Invasive Bladder Urothelial Carcinoma
Official title A Randomized Trial of Bicalutamide in Non-Muscle Invasive Bladder Cancer
ClinicalTrials.gov ID: NCT05521698
What this study is testing
What is Bicalutamide?
Bicalutamide is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for non-muscle invasive bladder urothelial carcinoma.
Also referred to as Casodex.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This phase I trial evaluates the effects of bicalutamide, compared to no study drug (NSD), on epidermal growth factor receptor (EGFR) protein expression in patients with non-muscle invasive bladder cancer. Bicalutamide is in a class of medications called androgen receptor inhibitors.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- Biologic male adults (\>= 18 years old)
- Note: Because no dosing or adverse event (AE) data are currently available on the use of bicalutamide in participants \< 18 years of age, children...
- Have suspected non-muscle invasive bladder carcinoma (NMIBC) on clinic-based cystoscopy or imaging as viewed by an American Urological Association...
- Have had cross sectional imaging of the abdomen and pelvis (computed tomography [CT] or magnetic resonance imaging [MRI] with or without contrast)...
- Note: If adenopathy or upper tract abnormalities are identified, a negative biopsy and or ureteroscopy is required prior to enrollment
You likely can't join if
- Participants who have had a previous exposure to sex hormone (e.g., exogenous androgens) or anti-androgenic therapies (e.g., luteinizing...
- Participants taking Coumarin derivative anticoagulation (e.g., warfarin). Other anticoagulation medications are allowed.
- Participants receiving any other investigational agents.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to bicalutamide.
- History of prior or concurrent muscle invading UC, or concurrent prostatic urethral, urethral, or upper tract UC or non-urothelial bladder cancer
- History of radiation therapy to the pelvis, prostate or prostatic bed, or rectum
See the full eligibility criteria
- Biologic male adults (\>= 18 years old)
- Note: Because no dosing or adverse event (AE) data are currently available on the use of bicalutamide in participants \< 18 years of age, children are excluded from this study but will be eligible for future pediatric...
- Have suspected non-muscle invasive bladder carcinoma (NMIBC) on clinic-based cystoscopy or imaging as viewed by an American Urological Association (AUA) board-certified urologist
- 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...
- Note: If adenopathy or upper tract abnormalities are identified, a negative biopsy and or ureteroscopy is required prior to enrollment
- Newly suspected, diagnosed, or occasionally recurrent bladder cancer (BC)
- Note: Occasional recurrence is defined as =\< 2 prior NMIBC episodes in the 18 months preceding cystoscopy where the index tumor was identified
- Participants with single and multiple tumor lesions
- Eastern Cooperative Oncology Group (ECOG) performance status =\< 1
- Total bilirubin =\ 1.5 x upper limit of normal, measure direct and indirect bilirubin and if direct bilirubin is =\< 1.5 x upper limit of normal, participants may be eligible)
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) =\< 2 × institutional upper limit of normal
- Alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) =\< 2 × institutional upper limit of normal
- Urine Culture \< 50,000 colonies/cc of 1 or more organisms (if found and treated and a confirmed negative culture obtained off antibiotics before study drug is started, they will be eligible)
- Serum Testosterone \>= 250 ng/dL
- Thyroid stimulating hormone (TSH) within institutional normal
- White blood cell count (WBC) \>= 0.5 × institutional lower limit of normal
- The effects of bicalutamide on the developing human fetus at the recommended therapeutic dose are unknown. For this reason, men who are having sex must wear a condom when engaging in any activity that allows for passage...
- Ability to understand and the willingness to sign a written informed consent document
- Participants who have had a previous exposure to sex hormone (e.g., exogenous androgens) or anti-androgenic therapies (e.g., luteinizing hormone-releasing hormone [LHRH] agonists, LHRH antagonists, 5 alpha...
- Participants taking Coumarin derivative anticoagulation (e.g., warfarin). Other anticoagulation medications are allowed.
- Participants receiving any other investigational agents.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to bicalutamide.
- History of prior or concurrent muscle invading UC, or concurrent prostatic urethral, urethral, or upper tract UC or non-urothelial bladder cancer
- History of radiation therapy to the pelvis, prostate or prostatic bed, or rectum
- Any condition (uncontrolled intercurrent illness, psychiatric illness, or social situation) for which, in the opinion of the investigator, participation would not be in the best interest of the participant (e.g...
- Participants with severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, uncontrolled hypertension, recent arterial or venous thromboembolic events (e.g. pulmonary embolism...
- In the opinion of the investigator, participant has underlying uncontrolled hypertension, high cholesterol, or diabetes.
- Allergy or hypersensitivity to bicalutamide, or excipients, unable or unwilling to take ADT.
- Plans to father a child while enrolled in this study or within 130 days after the last dose of study intervention.
The study team makes the final eligibility decision.
Where it's taking place
- Tucson, Arizona, United States
- Los Angeles, California, United States
- Bethesda, Maryland, United States
- Rochester, New York, United States
- Columbus, Ohio, United States
- Madison, Wisconsin, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tucson, Arizona, United States; Los Angeles, California, United States; Bethesda, Maryland, United States; Rochester, New York, United States; Columbus, Ohio, United States; Madison, Wisconsin, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.