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Study on Darolutamide, Triptorelin, and Leuprorelin Acetate for Patients with Newly Diagnosed Prostate Cancer and Pelvic Lymph Node Metastases

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying treatments for prostate cancer that has spread to the pelvic lymph nodes. The study will evaluate the effects of adding a medication called darolutamide to standard treatments, which include androgen deprivation therapy (ADT) and radiation therapy. Darolutamide is a type of medication known as an antiandrogen, which helps block male hormones that can promote cancer growth. The trial will also involve the use of other hormone therapies, such as triptorelin, leuprorelin acetate, and degarelix, which are given by injection to help reduce hormone levels in the body.

The purpose of this study is to see how well the combination of these treatments works in preventing the cancer from getting worse. Participants will be randomly assigned to receive either darolutamide or a placebo, along with the standard hormone and radiation therapies. The study will last for up to 24 months, during which time participants will receive regular check-ups and monitoring to assess their health and the effectiveness of the treatment.

Throughout the study, participants will undergo various tests and scans, such as MRI and CT scans, to monitor the cancer's response to treatment. The study aims to improve understanding of how these treatments can help manage prostate cancer and improve outcomes for patients. Participants will be closely monitored for any side effects or changes in their condition, and their quality of life will also be assessed during the trial period.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the patient will be informed about the trial's objectives and procedures. Written informed consent is required to participate.
The patient must meet specific health criteria, including a confirmed diagnosis of prostate cancer with pelvic lymph node metastases and a life expectancy of at least 36 months.
Step 2
Initial assessment
An initial assessment will be conducted, including imaging tests such as pelvic MRI and possibly a CT scan or PET-CT to confirm the extent of the disease.
Blood tests will be performed to ensure the patient meets the necessary health requirements, such as adequate blood counts and liver function.
Step 3
Treatment initiation
The treatment phase begins with the administration of androgen deprivation therapy (ADT), which may include medications like leuprorelin acetate or degarelix, given by injection.
Darolutamide, an oral medication, will be added to the treatment regimen. The dosage and frequency will be determined by the study protocol.
Step 4
Radiation therapy
Radiation therapy will be administered as part of the treatment plan. The schedule and duration will be specified by the study protocol.
The combination of darolutamide, ADT, and radiation therapy aims to improve failure-free survival.
Step 5
Follow-up and monitoring
Regular follow-up visits will be scheduled to monitor the patient's response to treatment and any side effects.
Blood tests, imaging studies, and assessments of prostate-specific antigen (PSA) levels will be conducted periodically to evaluate treatment effectiveness.
Step 6
End of study participation
The study participation will conclude after a 3-year follow-up period or earlier if specific criteria are met, such as disease progression or withdrawal from the study.
The primary goal is to assess the impact of the treatment on failure-free survival, with secondary goals including overall survival and quality of life.

Who can join the trial?

16 criteria

Must have been newly diagnosed with prostate cancer that has spread to the pelvic lymph nodes.
Must be at least 18 years old.
Must have a confirmed diagnosis of prostate adenocarcinoma, which is a type of prostate cancer.
Must have undergone initial staging tests, including a pelvic MRI and other scans to check the spread of cancer.
Any T stage of cancer is acceptable.
N stage must be N1, indicating cancer has spread to pelvic lymph nodes.
Must plan to undergo long-term hormone therapy for 24 months to lower male hormones.
Hormonal therapy with LHRH agonist or antagonist is allowed if started up to 3 months before the study.
Must be able to receive the study treatment and have a life expectancy of at least 36 months. ECOG Performance Status should be between 0 and 2, which measures daily living abilities.
Blood tests must show hemoglobin levels of at least 9.0 g/dl, a certain number of neutrophils (a type of white blood cell), and a platelet count of at least 100,000/μl. No recent growth factor or blood transfusion within 7 days before the test.
Screening blood tests must show liver enzymes (ALT and AST) less than 2.5 times the normal limit, total bilirubin less than 1.5 times the normal limit, and creatinine less than 2.0 times the normal limit. Exceptions are made for Gilbert's disease.
Sexually active participants must agree to use condoms during the study and for 3 months after the study ends, unless they are surgically sterile.
Must provide written informed consent to participate in the study.
Must be willing and able to follow the study's schedule for follow-up visits.
Must be part of the social security system.
Use of 5-alpha reductase inhibitors, such as finasteride or dutasteride, is allowed.

Who cannot join the trial?

8 criteria

Patients who have already received treatment for prostate cancer.
Patients with other types of cancer that are currently being treated.
Patients with serious heart problems, such as heart failure or recent heart attack.
Patients with severe liver or kidney disease.
Patients who are unable to follow the study procedures or attend study visits.
Patients who are allergic to the study medication or any of its ingredients.
Patients who are participating in another clinical trial.
Patients with any condition that the study doctors believe would make it unsafe to participate.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
CHU Grenoble Alpes
La Tronche, France
Verified
Centr Georges Francois Leclerc
Dijon, France
Verified
Centre Hospitalier Regional Et Universitaire De Brest
Brest, France

Trial locations

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Investigated drugs

Darolutamide
is a medication used in this trial to help treat prostate cancer. It works by blocking the effects of male hormones that can promote the growth of cancer cells. This medication is being tested to see if it can improve the outcomes for patients with prostate cancer that has spread to the pelvic lymph nodes.
Androgen Deprivation Therapy (ADT)
is a treatment that reduces the levels of male hormones in the body. These hormones can help prostate cancer cells grow, so lowering their levels can slow down or stop the growth of the cancer. ADT is a standard treatment for prostate cancer and is being used in this trial to see how well it works in combination with other therapies.
Radiotherapy
is a treatment that uses high-energy rays to target and kill cancer cells. In this trial, radiotherapy is used to treat prostate cancer that has spread to the pelvic lymph nodes. The goal is to see if combining radiotherapy with other treatments can improve patient outcomes.

What is already known about the treatment

Darolutamide – Darolutamide is administered orally in tablet form and is currently being evaluated in clinical trials for its effectiveness in treating newly diagnosed prostate cancer with pelvic lymph node metastases. It is an androgen receptor inhibitor, which means it works by blocking the action of male hormones that can promote the growth of cancer cells. This medication is classified as a non-steroidal antiandrogen and is being studied for its potential to improve survival outcomes when used in combination with androgen deprivation therapy (ADT) and radiotherapy.

Investigated diseases

Prostate Cancer with Pelvic Lymph Node Metastases – This condition occurs when prostate cancer cells spread from the prostate gland to the pelvic lymph nodes. Initially, prostate cancer may not cause noticeable symptoms, but as it progresses, it can lead to difficulties in urination, pelvic pain, and blood in the urine. When the cancer spreads to the lymph nodes, it indicates a more advanced stage of the disease. The progression involves the growth and multiplication of cancer cells in the lymph nodes, which can further spread to other parts of the body. Monitoring involves tracking changes in prostate-specific antigen (PSA) levels and imaging tests to assess the spread. The disease's progression can vary, with some patients experiencing rapid changes while others may have a slower course.