Finding Clinical Trials for Testicular Cancer

Clinical trials and testicular cancer

What is a Clinical Trial?

The clinical trial is one of the most important scientific tools medicine has to test and develop new treatments, which can include anything from surgery to medications. The clinical trial is the field test for new treatments. It will either prove them to be effective and safe or just the opposite. The clinical trial determines whether a certain treatment or medication actually makes it to the market, becoming available to healthcare providers and their patients.

The Food and Drug Administration (FDA) only approves medications and other treatments after adequate clinical trials have proven their efficacy and safety.

What are the Phases of a Clinical Trial?

There are typically four phases for clinical trials. Each one has unique purposes and characteristics. 

  • PHASE 1: The purpose of the phase I clinical trial is to determine the dose strength and scheduling of a certain medication or other treatment which is safe to use in cancer. It also gives the research team an idea about the type of condition that may be responding to the investigational drug. The main purpose of a phase I trial is to establish whether the drug is safe to further test for efficacy in a Phase II study. During this phase, the effectiveness of the treatment is not being assessed. The number of patients involved in this phase of a clinical trial is typically smaller than subsequent phases.
  • PHASE 2: The main purpose of the phase II clinical trial is to determine whether the drug has any efficacy in a given condition. It also further assesses the safety of the dose and strength of the medication that has been established in the Phase I study. A larger number of subjects are typically involved compared to phase I making side-effect monitoring more useful as well
  • PHASE 3: Phase III is typically the last phase before a treatment can seek approval from the FDA. The main purpose of the phase III clinical trial is to determine the effectiveness of a new therapeutic strategy for a given condition or a new drug compared with the previously used standard of care treatment or to placebo. The biggest difference between phase II and phase III is the involvement of a comparison group, which is typically treated with a previously established treatment or placebo, and compared to the group receiving the new test treatment. This way the actual effectiveness can be established or disproven since there is a control group available for comparison. Think of it like watching a sporting team. Watching a team practice by itself may give an idea of their skill but having them actively compete a well-established team would be far more effective at determining their true level of skill. Phase III trials also involve more participants than phase II.
  • PHASE 4: The fourth phase of a clinical trial investigates the long-term side effects of a new drug. This phase occurs after the drug has been officially approved and is being used in the mainstream outside of a structured clinical trial.

    What are the Advantages of a Clinical Trial?

    The most obvious benefit to a clinical trial is access to a treatment or medication that may potentially help you which would otherwise be inaccessible. In addition, the treatment may be free-of-charge. From a broader view, it aids tremendously in the advancement of medicine and treatments. This has never been truer than in the case of cancer. Nearly every treatment, including surgery, radiation, chemotherapy and other medications is a direct result of clinical trials.

    Are there Disadvantages to Clinical Trials?

    There are several potential drawbacks to clinical trials. Location can be an issue. Many clinical trials have several sites but travel or temporary relocation may be a necessity. Many trials are blinded. This means the participants don't know what treatment they're receiving. The main disadvantage of a clinical trial is that the agent, being investigational, may lack efficacy and it have unforeseen side effects.

    Ethical Issues in Clinical Trials

    Clinical trials are highly regulated and guided by ethical principles. Committees, commonly known as Institutional Review Boards or IRBs, must approve any planned clinical trial before it can recruit participants. Approval is based on safety and preservation of human rights. The IRB typically performs periodic follow-ups throughout the trial as well to make sure rights are preserved.

    When to Consider Clinical Trials for Testicular Cancer

    Most stages of testicular cancer are cured with treatments which are already available and well-established. Cure rates for testicular cancers in metastatic phase are 70-80% and there is an unmet need for some of the patients with metastatic testicular cancer. Therefore, in order to further  improve the cure rate of testicular cancer, it may be wise to see what clinical trials are available. This is particularly true if several high-risk features are present such as lack of a complete response to initial treatment, high volumes of tumor, and elevated tumor markers.

    How to Find Clinical Trials for Testicular Cancer

    There are several different approaches to finding an appropriate clinical trial.  For example, multiple online resources are available to anyone with internet access. ClinicalTrials.gov is the largest online database for trials. The National Institute of Cancer (NCI) also maintains a search specifically for NCI-sponsored trials. Outside of electronic resources, oncology practices, especially large academic centers, have professionals that can provide information on the availability of trials. Clinicaltrials.gov allows you to enter a generalized search term such as "testicular cancer". Results can be refined by location as well by other parameters. Contact information will be available with each trial.

    Eligibility

    Certain eligibility criteria must be met in order to participate in a clinical trial. Eligibility takes into account not only cancer type but also stage and prior treatments. Other health conditions, especially significant heart disease, may render potential participants ineligible. On clinicaltrials.gov, it gives information regarding inclusion and exclusion criteria for each trial. The best way is to check with the research team and find out whether you are eligible for the study or not.

    Other Considerations

    Clinical trials go beyond studying treatment protocols for cancer. For instance, there are trials that evaluate quality of life issues, follow-up for cancer survivors, management of side effects from treatment and genomic studies, just to name a few. It's worth doing a search simply to see what's available.

    For further questions regarding clinical trials, check with your cancer health care professionals.

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