Clinical trials are research studies that involve people. They’re the final step in a long process that begins with research in a lab and animal testing. Clinical trials aim to find out if a new medical treatment or strategy, like a drug, medical device, or procedure, is safe and effective for people.

They might also investigate ways to prevent diseases, diagnose conditions more accurately, or explore how to improve the quality of life for individuals with chronic illnesses. Clinical trials are essential in advancing medical knowledge and patient care.

Each clinical trial has specific eligibility criteria that determine who can participate. These criteria can include age, gender, type and stage of disease, previous treatment history, and other medical conditions. Some trials seek participants with specific illnesses or conditions, while others need healthy participants.

It’s important to remember that the criteria are not used to exclude potential participants personally, but rather to ensure the safety of the trial and to determine the effectiveness of the treatment.

There are several types of clinical trials, including treatment trials (testing new treatments), prevention trials (looking for better ways to prevent diseases), diagnostic trials (conducted to find better tests or procedures for diagnosing a particular disease), and quality-of-life trials (exploring ways to improve the quality of life for individuals with a chronic illness).

Clinical trials also go through various phases:

• Phase 1 trials are the first stage of testing in humans and aim to identify side effects and determine the treatment’s safety. These typically involve a small number of participants.

• Phase 2 trials continue to assess safety but also start to evaluate how well the new treatment works.

• Phase 3 trials involve several hundreds to thousands of patients and provide the critical information about effectiveness and side effects required for regulatory approval.

• Phase 4 trials happen after a treatment has been approved and are used to gather more information about long-term risks, benefits, and optimal use.

Remember, it’s important to discuss your options with your healthcare provider before deciding to participate in a clinical trial. They can provide personalized advice based on your situation and health status.

Use of placebos

Placebos are sometimes used in clinical trials to test whether the results of a drug are better than no treatment at all. In these cases, a placebo designed to look like the drug being tested, but without any of the active ingredients, is administered to some participants for the duration of the study.

If a placebo is used in a clinical trial, you’ll be informed before participating that patients will receive either the treatment being studied or the placebo, at random. Individual participants aren’t informed which one they’ll receive. If you have any questions about the effects of placebos or the reasons behind their use, ask your doctor or the clinical trial investigator.

Participating in a clinical trial is a serious commitment with several stages that may require more time and attention than standard treatment. It can involve more frequent check-ups and medical tests, and a possibility of experiencing unknown side effects. It’s crucial for participants to communicate openly with the healthcare team, ask questions, and report any changes in health.

Screening: Initially, potential participants undergo screening processes to ensure they meet the trial’s eligibility criteria. These criteria can include factors like age, gender, type and stage of disease, previous treatment history, and other medical conditions. The screening process often involves tests and procedures, such as blood tests or imaging scans.

Informed Consent: Before participation, each individual must fully understand the nature of the trial, its purpose, the procedures involved, potential risks, and benefits. This is called the informed consent process. It ensures patients can make informed decisions about their participation. Patients have the right to withdraw from the study at any time, for any reason, without any impact on their standard medical care.

Treatment Phase: Once enrolled, participants will typically enter the treatment phase. This could involve testing new medical interventions, such as drugs or procedures, or comparing existing treatments. Participants might be grouped into different “arms” or segments of the study, with each receiving a different treatment.

Participants will receive regular medical care from a research team, which typically includes doctors, nurses, and other health professionals. They will monitor the participant’s health closely and provide specific instructions regarding the treatment.

Follow-Up: After the treatment phase, participants enter the follow-up phase. The research team continues to monitor the participants for specific periods to assess the long-term effects and efficacy of the treatment. This phase can last for months or even years.

Data Collection: Throughout the trial, researchers will collect data about the participant’s health, the effect of the intervention, and any side effects. This data is crucial for understanding the intervention’s effectiveness and safety.

Remember, each clinical trial is unique, just like each patient’s journey. The potential benefits, such as accessing new treatments and contributing to medical research, must be weighed against the potential risks. Always consult with your healthcare provider to make the best decision for your health.

When getting involved in a clinical trial – there can be a lot of new terminology you haven’t heard before. Below is some common terminology used during a clinical trial:

Abiraterone: A medication used to decrease the production of testosterone in the body, used in the treatment of prostate cancer.

Androgen Deprivation Therapy (ADT): Treatments that reduce levels of male hormones in the body to help slow the growth of prostate cancer.

Biomarkers: Biological molecules found in blood, other body fluids, or tissues that are a sign of a normal or abnormal process, or of a condition or disease.

Bosniak Classification: A system used to classify kidney cysts based on imaging characteristics on intravenous contrast-enhanced computed tomography (CT) scan.

ccRCC (Clear Cell Renal Cell Carcinoma): The most common type of kidney cancer.

CT (Computed Tomography): An imaging technique that uses a series of X-ray images to create cross-sectional images of the body.

Cytotoxic Chemotherapy: A type of chemotherapy that kills cells, especially cancer cells, whether they are at rest or dividing.

Darolutamide: A medication used to treat non-metastatic castration-resistant prostate cancer.

DDR Gene Mutated mCSPC (DNA Damage Repair Gene Mutated Metastatic Castration-Sensitive Prostate Cancer): Prostate cancer that has spread to other parts of the body, continues to respond to treatments to lower testosterone, and has mutations in the genes that help repair damage to DNA.

Enzalutamide: A medication used to treat prostate cancer.

Ex-vivo: Outside the living body, in a laboratory setting.

GAG Scores: These could potentially refer to a specific scoring or rating system used in the trial, but the exact meaning isn’t clear without more context.

Leibovich Points: A scoring system used to predict the risk of kidney cancer spreading after the kidney has been removed.

Leuprolide: A medication used to treat prostate cancer by reducing the level of testosterone in the body.

Luteinizing hormone releasing hormone analog (LHRHA): A synthetic hormone that helps to decrease testosterone levels, used in the treatment of prostate cancer.

mCRPC (Metastatic Castration-resistant Prostate Cancer): A stage of prostate cancer where the cancer has spread to other parts of the body and continues to grow despite treatments to lower testosterone.

Metastatic: Referring to cancer that has spread from its original location to other parts of the body.

mHSPC (Metastatic Hormone-Sensitive Prostate Cancer): A type of prostate cancer that has spread to other parts of the body and is still responding to treatments that lower testosterone levels.

New Hormonal Agents (NHAs): A newer class of medications that block the effect of androgens, used in the treatment of prostate cancer.

nmCRPC (Non-metastatic Castration-resistant Prostate Cancer): A stage of prostate cancer where the cancer has not spread beyond the prostate but continues to grow despite treatments to lower testosterone.

Non-steroidal anti androgen (NSAA): A type of medication that blocks the effects of androgens (male hormones) in the body, used in the treatment of prostate cancer.

Olaparib: A medication used in the treatment of certain types of cancer, including metastatic castration-resistant prostate cancer.

Overall Survival (OS): The length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that patients diagnosed with the disease are still alive.

Pathological Complete Response (pCR): No evidence of cancer cells in a tissue sample removed during surgery or biopsy after treatment.

Pelvic Lymph Node Dissection (pLND): A surgical procedure to remove lymph nodes in the pelvic area to check for the spread of cancer.

Prospective Cohort: A research study that follows over time a group of similar individuals (cohorts) who differ with respect to certain factors under study, to determine how these factors affect rates of a certain outcome.

Proteomic: The large-scale study of proteins, particularly their structures and functions.

Radical Prostatectomy (RP): A surgical procedure to remove the entire prostate gland and some of the tissue around it, used to treat prostate cancer.

Radiographic Progression-Free Survival (rPFS): The length of time during and after treatment that a patient lives with cancer but it does not get worse as measured by imaging tests.

Survivorship: The health and life of a person following the end of cancer treatment.

Talazoparib: A medication used to treat certain types of cancer, including prostate cancer, in patients with specific genetic mutations.

(Alberta Prostate Cancer Research Initiative)

GAG Scores for Surveillance of Recurrence in Leibovich Points ≥5 non-metastatic ccRCC (AUR87A).

AUR87A is an observational prospective multicenter diagnostics test cohort study for detection of renal cell carcinoma recurrence as determined by the reference standard, which is imaging using computed tomography (CT) of the chest and abdomen at defined intervals after primary surgery. (More Information)

A Study in Which Non-metastatic Castration-resistant Prostate Cancer (nmCRPC) Patients for Whom a Decision to Treat with Darolutamide Has Been Made Before Enrollment Are Observed and Certain Outcomes Are Described (DAROL)

The purpose of this study is to find out in the real-world setting, if darolutamide is safe and effective for patients diagnosed with prostate cancer that has not spread to other parts of the body. When a patient is enrolled to the study, his/her physician would have already made the decision to treat patient with darolutamide per local standard practice. (More Information)

Safety and Efficacy Study of Enzalutamide Plus Leuprolide in Patients with Nonmetastatic Prostate Cancer (EMBARK)

The purpose of this study is to assess enzalutamide plus leuprolide in patients with high-risk nonmetastatic prostate cancer progressing after radical prostatectomy or radiotherapy or both. (More Information)

Enzalutamide in First Line Androgen Deprivation Therapy for Metastatic Prostate Cancer (ENZAMET)

The purpose of this study is to determine the effectiveness of enzalutamide, versus a conventional non-steroidal anti androgen (NSAA), when combined with a luteinizing hormone releasing hormone analog (LHRHA) or surgical castration, as first line androgen deprivation therapy (ADT) for newly diagnosed metastatic prostate cancer. (More Information)

A research study for men who are not receiving any active treatment for their prostate cancer (active surveillance). This study aims to evaluate the biomarkers in urine samples to examine the presence of prostate cancer as well as determining how aggressive the cancer is.

Characterizing the Landscape of Genomic, Proteomic and Molecular Profiling of Urological Cancer with Ex-vivo Assessment of Tumors: A Prospective Cohort

A Study of Participants with Advanced Prostate Cancer in Canada (GURC)

The purpose of this study is to document the course of advanced prostate cancer in Canada in terms of disease progression, real-world treatment, and patient management. (More Information)

The purpose of the study is to determine if the intermittent use of androgen-deprivation therapy (ADT) in participants with metastatic castrate-sensitive prostate cancer (mCSPC) who reached a prostate-specific antigen (PSA) level < 0.2 nanograms/millilitres (ng/mL) after 6 months of treatment with apalutamide and ADT combination therapy provides non-inferior radiographic progression-free survival (rPFS) and a reduced burden of hot flashes measured as 18-month percent change in severity adjusted hot flash score. More Information

Evaluating the Effectiveness of the Nurse Ned Clinic (NurseNed)

The purpose of this non-randomized control trial is to evaluate the effectiveness of a virtual nurse-led survivorship clinic for prostate cancer (PCa) survivors. Through this trial, investigators will compare pre-determined survivorship outcomes of men receiving care via traditional specialist-led PCa virtual care model (Specialist Ned) to those receiving care via the newly-proposed nurse-led PCa virtual care model (Nurse Ned). (More Information)

This is the first pilot phase II trial assessing the response of SBRT layered on Darolutamide (BAY1841788) on RPFS and deferring palliative second line systemic therapy in M0CRPC with oligoprogression. More Information

Study on Olaparib Plus Abiraterone as First-line Therapy in Men with Metastatic Castration-resistant Prostate Cancer

The purpose of this study is to evaluate the efficacy and safety (including evaluating side effects) of combination of olaparib and abiraterone versus placebo and abiraterone in patients with metastatic castration-resistant prostate cancer (mCRPC) who have received no prior cytotoxic chemotherapy or new hormonal agents (NHAs) at metastatic castration-resistant prostate cancer (mCRPC) stage. (More Information)

A Study of Apalutamide in Participants with High-Risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy (PROTEUS)

The purpose of this study is to determine if treatment with apalutamide plus androgen deprivation therapy (ADT) before and after radical prostatectomy (RP) with pelvic lymph node dissection (pLND) in participants with high-risk localized or locally advanced prostate cancer results in an improvement in pathological complete response (pCR) rate and metastasis-free survival (MFS) as compared to placebo plus ADT. (More Information)

Surveillance of Complex Renal Cysts – The SOCRATIC Study (SOCRATIC)

One third of individuals aged >60 years will be diagnosed with at least one renal cyst following abdominal imaging. These cystic lesions are categorized according to the Bosniak classification which categorizes cysts according to their degree of complexity and risk of malignancy. Growing evidence suggests that a significant proportion of Bosniak III and IV cysts are benign and that the malignant ones present low metastatic potential. Since renal surgery carries substantial morbidity (20%) and potential mortality (0.5%), active surveillance has gained attention as a potential tradeoff to surgery to overcome overtreatment. Therefore, prospective studies of long-term follow-up are needed to confirm the oncologic safety of this strategy for patients with Bosniak III/IV cysts. (More Information)

A Study of Apalutamide (ARN-509) in Men with Non-Metastatic Castration-Resistant Prostate Cancer (SPARTAN)

The purpose of this study is to evaluate the efficacy and safety of apalutamide in adult men with high-risk non-metastatic castration-resistant prostate cancer. (More Information)

This multi-center, phase 2, randomized, single-blind, three-arm, active-controlled study is comparing repeat doses, every 28 days, of standard of care (SOC) plus ST-01 against SOC plus 1% lidocaine HCL in men experiencing chronic scrotal content pain (CSCP). The main purpose of this study is to determine if repeat injections of ST-01 are safe and effective in reducing pain. After completing a screening phase participants will be randomized into one of three groups: 1) ST-01 70 mg/mL arm, 2) ST-01 140 mg/mL arm, 3) 1% Lidocaine HCL arm (Control). Participants will receive up to 4 study treatment injections at 28-day intervals. Participants randomized to the Control arm will be given the opportunity to cross over to an ST-01 treatment arm after 2 study treatments. More Information

Study of Talazoparib with Enzalutamide in Men With DDR Gene Mutated mCSPC

The purpose of the study is to evaluate the safety and efficacy of talazoparib in combination with enzalutamide compared with placebo in combination with enzalutamide in participants with DDR-deficient mCSPC. (More Information)

A Study of Apalutamide (JNJ-56021927, ARN-509) Plus Androgen Deprivation Therapy (ADT) Versus ADT in Participants With mHSPC (TITAN)

The purpose of this study is to determine if the addition of apalutamide to ADT provides superior efficacy in improving radiographic progression-free survival (rPFS) or overall survival (OS) for participants with mHSPC. (More Information)