Have you been diagnosed with Metastatic Castration Resistant Prostate Cancer (mCRPC)?

Consider joining the LORIKEET clinical trial for people living with Metastatic Castration Resistant Prostate Cancer (mCRPC)
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Short Clinical Trial Summary

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Medical Condition

Metastatic Castration Resistant Prostate Cancer (mCRPC)
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Participation Duration

  • Screening: 28 Days ​
  • Treatment: up to 2 years ​
  • Follow up: up to 2 years
  • Total duration: up to 4 years
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Clinical Trial Phase

2

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What is Metastatic Castration Resistant Prostate Cancer (mCRPC)?

Prostate cancer is the second most frequent cancer and the fifth leading cause of cancer death in men around the world. Prostate cancer is commonly treated with medications to reduce levels of male hormones in the body (such as testosterone). This treatment is called androgen deprivation therapy (ADT). Unfortunately, cancer that initially improves from ADT may eventually become resistant to treatment and continue to progress. When this happens, it is called castration resistant prostate cancer (CRPC). Once the cancer has spread to other parts of the body such as the bones or lymph nodes, the cancer is considered metastatic.
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What is the LORIKEET clinical trial?

The goal of the LORIKEET clinical trial is to learn more about an investigational medication, lorigerlimab, and its safety and efficacy (how well it works) in patients with metastatic castration resistant prostate cancer (mCRPC). “Investigational” means that the medication is not currently approved by any health authority except for use in clinical trials, like the LORIKEET trial. The investigational medication, lorigerlimab, is an immunotherapy treatment. Immunotherapy drugs change how a person’s immune system works so that it may be used to fight cancer or other diseases.

Participants in the LORIKEET trial will be assigned randomly (like rolling dice) to one of two groups:

Lorigerlimab in combination with an approved standard of care regimen for mCRPC (docetaxel and prednisone)
Standard of care (docetaxel and prednisone) only

Lorigerlimab and docetaxel will be administered through a needle in a vein (intravenously or IV) at the clinical trial center once every three weeks. Prednisone will be taken twice a day by mouth as a tablet.

You have a 2 out of 3 chance of receiving the investigational medication in combination with standard of care (docetaxel and prednisone). Docetaxel and prednisone are approved in the United States (US), Europe, Australia, and other regions for treating mCRPC. If you are eligible to join the trial and decide to participate, your clinical trial doctor will tell you what drugs you will receive.

Who can participate in the LORIKEET clinical trial?

You may be eligible to participate in the LORIKEET clinical trial if you:
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Are at least 18 years old
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Have been diagnosed with metastatic castration-resistant prostate cancer (mCRPC)
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Have received prior androgen receptor axis targeted therapies (ARAT) e.g., abiraterone, enzalutamide and others

What happens if I participate?

Before deciding if you want to take part in this clinical trial, the trial doctor will discuss your options and provide you with detailed information about the trial and what it means to participate. Part of the clinical trial information provided by the trial doctor is an informed consent document. Please take your time and read this information carefully. It is important that you ask your trial doctor if something is unclear or if you have any questions about the trial before you sign the Informed Consent Form. Whether or not you decide to join the LORIKEET trial is completely your decision. You can withdraw at any time and for any reason.

The trial is divided into several parts:

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LORIKEET Trial Screening Period
(up to 4 weeks)

Your medical history will be reviewed and tests will be done to find out if you can participate.
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LORIKEET Trial Treatment Period
(up to 2 years depending on if and how long you respond to the treatment and whether you have side effects from the treatment)

During this period, you will visit the trial center to perform different tests, such as blood tests, tumor assessments, physical exams and vital signs. You will receive the treatment you have been assigned every three weeks. During this time, your health will be continuously monitored by your trial doctor.
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Follow Up Period
(up to 2 years)

You will need to visit the trial center about 30 days after your final dose of trial medication. As part of the follow-up period, you will be contacted about every 3 months for up to 24 months after the treatment period has been completed to assess your health status. If you discontinue treatment before your cancer worsens, you will continue to have additional blood tests and scans every 12 weeks for up to 24 months.
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How do I Participate?

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Submit your contact information.

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Answer our call to answer more questions and learn about the trial.

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Confirm your interest and trial center location.

Speak with the trial center about the next steps to participate.

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More information about the trial centers taking part in the LORIKEET clinical trial is available here, at ClinicalTrials.gov.

Please enter your contact details so that the medical professional can reach you to discuss trial participation.

Submitting your contact details does not mean you have to join the trial. That is your decision to make if you are eligible for the trial.

Frequently Asked Questions

Where can I find more information about this trial?

You can learn more about this trial by visiting https://www.clinicaltrials.gov/study/NCT05848011.

What is a clinical trial?

Clinical trials explore whether a new drug, treatment, or device is safe and effective for humans.

Clinical trials are scientific studies in which new drugs and treatments are tested to find out if they are safe and effective for people to take and use. They are one of the most important steps in bringing new potential treatments to patients.

Does it cost anything to participate?

No. Participants will receive the investigational or standard-of-care medicine and all clinical trial-related assessments and procedures at no cost.

Why is clinical research important?

Clinical research adds to medical knowledge and helps bring new potential treatments to people with medical conditions. To bring new treatments to the public, they need be assessed in clinical trials to determine if they work and are safe.

Clinical trials rely on the participation of volunteers. It can take several years for a new potential treatment to reach the public. Often, this timeline is due to how long it takes to complete the clinical trial.

Prescription drugs go through clinical trials to make sure that they are effective and to understand what side effects may be involved.

Who runs clinical trials?

Clinical trials can be sponsored or funded by pharmaceutical or biotechnology companies, academic medical centers, voluntary groups, or health care providers. The LORIKEET trial is sponsored and funded by a biopharmaceutical company, MacroGenics, Inc.

Every clinical trial center is led by a principal investigator, who is a medical doctor. Clinical trials also have a research team that may include doctors, nurses, and other health care professionals.

What are the phases of clinical trials?

Clinical trials are conducted in different phases.

Phase I

The first trial in humans. These are small trials with 20-100 participants, mostly in healthy volunteers. The main objectives are to investigate:

  • Safety of the trial medication
  • How the trial medication is absorbed by the body and what dosage should be used
  • How the trial medication is removed from the body
  • Potential side effects

Phase II

Small trials with around 100-500 participants. The main objectives are to investigate:

  • Ongoing safety
  • Whether the trial medication works for a particular disease
  • The best dose of the trial medication

Phase III

Large trials with around 500 or more participants. These are the main trials for final approval by health authorities. The main objectives are to investigate:

  • Safety and side effects in bigger populations
  • Whether the trial medication works for a particular disease
  • How the treatment compares to already existing standard therapies

Phase IV

Large trials in patients after the trial medication has been approved by regulatory authorities for prescription use (or public use if it isn’t a medicine that requires a prescription). The main objectives are to investigate:

  • Side effects during day-to-day use in the population
  • Risks and benefits over a longer period of time

Who are Trialbee and what role do they play?

Trialbee is a global patient recruitment company working together with MacroGenics (the sponsor) on the LORIKEET trial to assist with the identification of potential participants.

Do I have to go through Trialbee to participate in this clinical trial?

No. This is just one option. A list of the trial centers that are taking part in the LORIKEET clinical trial is available on clinicaltrials.gov. You should discuss the trial with your doctor if you are interested in learning more.

The Trialbee process is designed to help determine if you may be eligible to participate in the clinical trial, if participation may be right for you and will connect you with your nearest clinical trial center.