Apalutamide for Bladder Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether the drug apalutamide (also known as Erleada) can affect a protein called EGFR, linked to bladder cancer progression. Apalutamide blocks certain hormones to slow or stop cancer cell growth. Participants will receive either apalutamide or a placebo to observe the effects on the protein. The trial seeks men recently diagnosed with non-muscle invasive bladder cancer who have undergone imaging tests showing no signs of advanced cancer. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the chance to contribute to early-stage cancer research.
Will I have to stop taking my current medications?
The trial requires you to stop taking certain medications that increase seizure risks, anticoagulants, and any drugs that have severe interactions with apalutamide. If you are on these medications, you may need to stop them before participating.
Is there any evidence suggesting that apalutamide is likely to be safe for humans?
Research has shown that apalutamide, a drug that blocks certain hormones, has mostly been studied in prostate cancer. In these studies, patients generally tolerated the treatment well, and serious side effects were rare. For instance, only 0.2% of patients experienced severe issues like a stroke. However, these results come from prostate cancer studies, not bladder cancer, which means bladder cancer patients might react differently to the treatment.
Since apalutamide is in an early stage of testing (phase 1) for bladder cancer, researchers are still collecting safety information specifically for this condition. Phase 1 trials are the first step in clinical testing and mainly focus on safety. While some safety evidence exists from prostate cancer studies, more research is needed to confirm its safety for bladder cancer patients.12345Why do researchers think this study treatment might be promising for bladder cancer?
Unlike the standard treatments for bladder cancer, which often include surgery, chemotherapy, and immunotherapy, apalutamide brings a fresh approach by targeting the androgen receptor pathway. Researchers are excited about apalutamide because it is traditionally used in prostate cancer to block hormones that fuel cancer growth, and they believe it might have similar benefits for bladder cancer. This represents a novel mechanism of action for this type of cancer, potentially offering a new line of attack against tumors. The hope is that apalutamide could provide a more targeted and effective treatment option, possibly with fewer side effects compared to existing therapies.
What evidence suggests that apalutamide might be an effective treatment for bladder cancer?
This trial will compare the effects of apalutamide with a placebo in patients undergoing TURBT for bladder cancer. Research has shown that apalutamide can help treat certain types of prostate cancer by blocking male hormones that promote cancer growth. Studies have found that it significantly lowers the risk of cancer spreading and improves survival rates for prostate cancer patients. For bladder cancer, experts believe apalutamide might work by targeting similar growth pathways. Although direct data on its effects in bladder cancer is limited, its known mechanism provides a strong rationale for exploration. Early findings in related cancers suggest that apalutamide could benefit non-muscle invasive bladder cancer by affecting a protein linked to disease progression.12367
Who Is on the Research Team?
Edward M Messing
Principal Investigator
University of Wisconsin, Madison
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive apalutamide or placebo orally once daily for up to 28 days, with TURBT on day 21
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Apalutamide
Trial Overview
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.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Patients receive apalutamide PO QD on days 1-21. Patients undergo TURBT on day 21. Up to 28 days of apalutamide prior to TURBT is permitted in the absence of unacceptable toxicity. Patients undergo blood and urine sample collection throughout the study. Patients may optionally undergo tumor biopsy at baseline.
Patients receive placebo PO QD on days 1-21. Patients undergo TURBT on day 21. Up to 28 days of placebo prior to TURBT is permitted in the absence of unacceptable toxicity. Patients undergo blood and urine sample collection throughout the study. Patients may optionally undergo tumor biopsy at baseline.
Apalutamide is already approved in United States, European Union for the following indications:
- Non-metastatic castration-resistant prostate cancer (nmCRPC)
- Metastatic castration-sensitive prostate cancer (mCSPC)
- Non-metastatic castration-resistant prostate cancer (nmCRPC)
- Metastatic castration-sensitive prostate cancer (mCSPC)
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor
Published Research Related to This Trial
Citations
1.
innovativemedicine.jnj.com
innovativemedicine.jnj.com/us/johnson-johnson-highlights-ambition-transform-treatment-prostate-cancer-and-bladder-cancer-throughJohnson & Johnson Highlights Ambition to Transform the ...
Key presentations will include new real-world evidence data adding to the strong and differentiated clinical profile of ERLEADA® (apalutamide) ...
Survival outcomes of apalutamide as a starting treatment
In the TITAN trial in mHSPC, the combination of APA + ADT reduced the risk of radiographic progression-free survival by 52% (p < 0.001), reduced ...
Efficacy | ERLEADA® (apalutamide) HCP
Median follow-up time was 44.0 months. 1. The survival rate at 48 months was 65.1% for ERLEADA ® + ADT patients vs 51.8% for placebo + ADT patients.
ERLEADA® (Apalutamide) Demonstrates Statistically ...
October 7, 2024; Largest head-to-head real-world study in mCSPC demonstrated that ERLEADA® reduced risk of death by 23 percent at 24 months ...
Apalutamide holds potential in NMIBC, expert says
In numerous circumstances, apalutamide, when combined with castrative therapies, makes those castrative therapies more effective. Patients live ...
6.
jnjmedicalconnect.com
jnjmedicalconnect.com/products/erleada/medical-content/erleada-use-of-erleada-in-high-risk-localized-or-locally-advanced-prostate-cancerUse of ERLEADA in High-Risk Localized or ...
A summary of clinical data regarding ERLEADA® (apalutamide) use in patients with high-risk localized or locally advanced prostate cancer.
PATIENT-REPORTED OUTCOMES FOR HRQoL 1-6
Across the SPARTAN and TITAN studies, 3 patients (0.2%) treated with ERLEADA® and 2 patients (0.2%) treated with placebo died from a cerebrovascular event.
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