1. Prostate cancer is the most common non-skin cancer in America, and the 4th most
common tumor diagnosed worldwide.
2. In the United States, 1 in 8 men will be diagnosed with prostate cancer in his lifetime.
For men of African descent, 1 in 5 men will develop the disease.
3. A man of African descent is 73% more likely to develop prostate cancer than a
Caucasian man, and is nearly 2.3 times more likely to die from the disease.
4. In 2017, more than 161,000 men will be diagnosed with prostate cancer, and nearly
27,000 men will die from the disease. One new case occurs every 3.3 minutes and
a man dies from prostate cancer every 20 minutes.
5. A non-smoking man is more likely to develop prostate cancer than he is to develop
colon, bladder, melanoma, lymphoma and kidney cancers combined.
6. It is estimated that more than 3 million American men are living with prostate cancer.
7. As men increase in age, their risk of developing prostate cancer increases
exponentially. About 6 in 10 cases are found in men over the age of 65.
8. Men with relatives—father, brother, son—with a history of prostate cancer are twice
as likely to develop the disease.
9. If the cancer is caught at its earliest stages, most men will not experience
10. Prostate cancer is 100% treatable if detected early.
- How long does the average trial last?
- What if I am on other medication(s) from my regular doctor?
- What are the risks involved?
- What if I am harmed?
- Are there any tests requiring painful shots or blood samples?
- What should I do if I want a friend/parent to join a study?
- Will I be paid?
- Will I be reimbursed for gas?
- What kinds of medical problems would prevent participation in the clinical trial?
- Do I have to talk to my health insurance company before enrolling in a study?
- What if I miss a dose?
- Can I drop out at any time?
- Are there placebos involved?
If you decide that a clinical study may be right for you, make a list of questions and discuss them with the study doctor at your initial visit.
After a study is complete, the FDA decides whether to continue or halt the drug’s development. If it remains in development, the sponsor may build in a compassionate use extension for the study. This means that eligible patients may receive the study drug for a predefined amount of time without having to undergo any typical study procedures, such as blood tests or clinical ratings. This usually occurs in later studies, such as Phase III and Phase IV (post-marketing surveillance).
In some cases, a study doctor may dispense approved medication samples and provide additional consultation free of charge. These are just a few of the ways he or she might show appreciation for a patients involvement in a study.
There are three primary phases an investigational drug has to go through before it can be approved by the FDA, and a fourth phase that an approved drug may enter.
In this phase of a clinical trial, the sponsor wants to determine the maximum tolerated dose for the medication. Mode of action (how the drug exerts its effects), safety and side effects – these are some of the main issues that are of the utmost concern to drug makers at this stage of the clinical trial process. It is important to note that in Phase I studies, the overall safety of the medication in patients has not been established. Efficacy in Phase I, if observed, must be considered anecdotal until confirmed in more advanced studies.
A drug reaches Phase II only when the FDA has reviewed the Phase I data and concludes that the drug is safe for patients, and that its clinical activity may be beneficial against a particular disease or condition. At this point, a larger group of patients are enrolled and condition- or disease-specific rating scales are used to record data. The goals are to continue safety assessment and to determine dosage for pivotal, Phase III efficacy trials.
This is an important turning point for drug development. The medication has already passed the rigorous testing and review process required by the FDA, and now it is ready to be studied in an even larger patient population, with even more advanced rating scales and clinical measures. In recent years, there has been a growing industry trend to not only measure clinical effectiveness at this phase, but also measure “real world” results. For example, if patients show clinical improvement after entering the study, how are their activities of daily living improving (e.g., patients can work in the garden more often or attend their child’s games on a regular basis)? Most medications that reach Phase III will at least be considered for approval by an FDA advisory board.
At this phase in development, the drug has already been granted FDA approval. Phase IV studies are often performed to either identify an additional use for an already approved drug, or to gather additional safety information from a larger group of patients. In some cases, Phase IV studies are implemented to establish effectiveness in a subgroup of patients, for example, patients over age 65.
The FDA is the governing agency that develops the policies and guidelines for all clinical research, regardless of manufacturer, study phase or drug type. There are also independent Institutional Review Boards (IRB) that review and approve all study-related documents, such as protocols, Informed Consent forms, physician credentials and eligibility, and patient recruitment materials, such as print advertisements and public service announcements. (See “Protocol” and “Informed Consent” Form in the “Common Terms Used in Clinical Trials” section.)
There are several reasons why clinical trials are important. First, the participant may have a positive response to the study medication, and his disease or condition may improve. In addition, participants receive free laboratory and medical testing. More often than not, the study medication is in development because it works differently than other drugs on the market, and therefore, it may present an alternative course of treatment for the patient.
Second, participation in a clinical trial helps manufacturers make informed decisions about whether to pursue getting a particular drug approved by the Food & Drug Administration (FDA). In the best-case scenarios, these data can help get a new medication approved by the FDA, and ultimately continue the industry’s efforts in developing medications that are safer, more effective, and work faster than any before them.
A clinical trial is the investigation of a new medication for the treatment of a disease. The work might be sponsored by a pharmaceutical or biotechnology company, government or a private foundation. The purpose of these studies is to find out whether a medication is safe to use and effective against various diseases or medical conditions. In order to study the medication, several questions need to be answered first. For example, what patient population or disease is the drug meant to treat? What criteria should be used for accepting participants into the study? What general and disease-specific information are the study doctors going to obtain?
Essentially, once these and other important study questions are answered, the study doctors (investigators) are chosen, the regulatory documents are approved and the study is ready to begin.
Prostate cancer is the most common non-skin cancer in America, affecting 1 in 8 men.
In 2017, more than 161,000 men will be diagnosed with prostate cancer, and nearly 27,000 men will die from the disease. One new case occurs every 3.3 minutes and
a man dies from prostate cancer every 20 minutes.
It is estimated that more than 3 million American men are living with prostate cancer.
A non-smoking man is more likely to develop prostate cancer than he is to develop colon, bladder, melanoma, lymphoma and kidney cancers combined.
As men increase in age, their risk of developing prostate cancer increases exponentially. Although only 1 in 10,000 under age 40 will be diagnosed, the rate shoots up to 1 in 38 for ages 40 to 59, and 1 in 14 for ages 60 to 69. About 60% of all prostate cancers are diagnosed in men over the age of 65 and 97% occur in men 50 years of age and older.
African American men are 56% more likely to develop prostate cancer compared with Caucasian men and nearly 2.5 times as likely to die from the disease. You can read more about prostate cancer in African American men here.
Men with a single first-degree relative—father, brother or son—with a history of prostate cancer are twice as likely to develop the disease, while those with two or more relatives are nearly four times as likely to be diagnosed. The risk is highest in men whose family members were diagnosed before age 65.