Recruiting

Study on Darolutamide and Triptorelin for Patients with Localized High-Risk Prostate Cancer

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 prostate cancer, specifically in patients who have a high risk of the cancer returning after treatment. The study will explore the effectiveness of a medication called darolutamide, which is taken as a film-coated tablet, and a type of targeted radiation therapy known as stereotactic dose escalated radiotherapy. Additionally, the study will involve the use of triptorelin, a medication given as an injection, which helps manage hormone levels in the body.

The purpose of the study is to determine how well these treatments work together to prevent the spread of cancer to other parts of the body. Participants will receive either the medication, the radiation therapy, or a combination of both, and some may receive a placebo. The study will last for up to 24 months, during which time participants will have regular check-ups and assessments to monitor their health and the progress of the treatment.

Throughout the study, the main focus will be on how long patients remain free from cancer spreading, known as metastasis-free survival. Other aspects being monitored include the overall survival of patients, the time it takes for the cancer to return locally, and the quality of life of the participants. The study aims to provide valuable information on the safety and effectiveness of combining these treatments for patients with high-risk localized prostate cancer.

The research process

The trial runs in 5 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 must have signed a written informed consent form. This is a document that confirms understanding and agreement to participate in the trial.
The patient must meet specific health criteria, such as having adequate blood counts and liver function, and must be willing to comply with the trial protocol.
Step 2
Initial assessment
The patient undergoes an initial assessment to confirm eligibility. This includes a review of medical history and a physical examination.
Imaging tests, such as MRI and PSMA PET/CT, are conducted to ensure there are no detectable metastases.
Step 3
Treatment phase
The patient begins treatment with darolutamide, which is administered as a film-coated tablet taken orally. The dosage and frequency are determined by the study protocol.
In addition to darolutamide, the patient receives triptorelin, which is administered either intramuscularly or subcutaneously. This medication is part of the androgen deprivation therapy (ADT).
The patient may also receive stereotactic dose escalated radiotherapy targeting the prostate and pelvic nodal radiotherapy, depending on the study group assignment.
Step 4
Monitoring and follow-up
Throughout the trial, the patient attends regular follow-up visits to monitor health status and treatment effects.
These visits include physical examinations, blood tests, and imaging studies to assess the response to treatment and check for any side effects.
Step 5
End of treatment
At the end of the treatment phase, the patient undergoes a final assessment to evaluate the overall response to the therapy.
The patient continues to be monitored for long-term outcomes, including metastasis-free survival and quality of life.

Who can join the trial?

15 criteria

Must have signed a written informed consent form before any trial-specific procedures.
Must have a **haemoglobin** level of at least 90 g/L, without having received a red blood cell transfusion in the last 4 weeks.
Must have normal **liver function**, with specific blood tests (ALT and AST) not more than 2.5 times the normal limit, and **bilirubin** not more than 1.5 times the normal limit.
Must have a **creatinine** level not more than 2 times the normal limit, indicating normal kidney function.
If sexually active, must agree to use an effective method of birth control during treatment and for 1 week after the last dose of the study drug.
Must have health insurance, either through a Social Security System or equivalent private insurance, as required by local regulations for clinical trials.
Must be willing and able to follow the study protocol, including attending treatment sessions, scheduled visits, and follow-up exams.
Must be a man aged between 18 and 80 years.
Must have an **ECOG performance status** of 0 or 1, which means being fully active or having some symptoms but still able to carry out light work.
Must not have any significant health issues that could prevent long-term follow-up.
Must have a confirmed diagnosis of **adenocarcinoma of the prostate**, a type of prostate cancer.
Must meet at least 2 high-risk criteria from the NCCN classification for prostate cancer.
Must have a prostate size of less than 100 cc as measured by an MRI scan.
Must have an **absolute neutrophil count** of at least 1.5 x 10^9/L, indicating a healthy level of a type of white blood cell.
Must have a **platelet count** of at least 100 x 10^9/L, indicating a healthy level of cells that help with blood clotting.

Who cannot join the trial?

6 criteria

Patients who do not have localized prostate cancer with high-risk features of relapse.
Patients who do not meet at least 2 high-risk criteria from the National Comprehensive Cancer Network (NCCN) classification.
Patients with detectable metastasis, which means the cancer has spread to other parts of the body.
Patients with evidence of pelvic lymph node metastasis, meaning the cancer has spread to the lymph nodes in the pelvic area.
Female patients, as the study is only for male subjects.
Patients who are considered part of a vulnerable population, which means they might need special protection or care.

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Verified sites

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

CHU De Martinique
Verified
Fort De France, France
Centr Georges Francois Leclerc
Verified
Dijon, France
Institut De Cancerologie De Lorraine
Responsive
Vandoeuvre Les Nancy, France

Trial locations

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Investigated drugs

Darolutamide
is a medication used in this trial to help treat localized 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 time patients remain free from cancer spreading to other parts of the body.
Stereotactic Dose Escalated Radiotherapy
is a type of radiation therapy used in this trial. It involves delivering high doses of radiation precisely to the prostate cancer cells. The goal is to increase the effectiveness of the treatment by targeting the cancer more accurately, potentially reducing the risk of the cancer returning or spreading.
ADT (Androgen Deprivation Therapy)
is a treatment that reduces the levels of male hormones in the body, which can help slow the growth of prostate cancer. In this trial, ADT is used in combination with other therapies to see if it can improve outcomes for patients with high-risk localized prostate cancer.
Pelvic Nodal Radiotherapy
is a form of radiation therapy that targets the lymph nodes in the pelvic area. This treatment is included in the trial to determine if it can help prevent the spread of prostate cancer by treating areas where cancer cells might have spread.

What is already known about the treatment

Darolutamide – Darolutamide is administered orally in tablet form. It is currently being studied in clinical trials for its effectiveness in treating localized prostate cancer with high-risk features of relapse. The main therapeutic indication is for patients with prostate cancer who have no detectable metastasis. At the molecular level, darolutamide works by blocking androgen receptors, which are involved in the growth of prostate cancer cells. It is classified as an androgen receptor inhibitor.

Investigated diseases

Prostate Cancer – Prostate cancer is a disease where cells in the prostate gland grow uncontrollably. It often progresses slowly and may not show symptoms in the early stages. As it advances, it can cause urinary problems, pelvic discomfort, and erectile dysfunction. High-risk localized prostate cancer refers to cancer that is confined to the prostate but has features suggesting a higher chance of spreading. These features can include a high PSA level, a high Gleason score, or evidence of cancer spreading to nearby tissues. The disease is monitored for signs of progression, such as metastasis or biochemical changes.