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A Study of Cabazitaxel and Pelvic Radiation Therapy Combined with Hormone Treatment for Patients with High-Risk Localized 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 focuses on patients with localized prostate cancer who have high-risk features that make the cancer more likely to return after treatment. The study examines the effectiveness of combining different treatments: cabazitaxel (given as an intravenous infusion), pelvic radiotherapy, and hormone therapy (also known as ADT - Androgen Deprivation Therapy).

The purpose of this research is to determine if adding cabazitaxel treatment and radiation therapy to the pelvic lymph nodes can improve how long patients remain free from cancer progression when combined with standard hormone therapy and radiation treatment. The medication being studied, cabazitaxel (brand name Jevtana), belongs to a group of drugs called antineoplastic agents that are used to treat cancer.

During the study, participants will receive cabazitaxel through an intravenous infusion (delivered directly into a vein), along with radiation therapy to the pelvis area. The treatment period lasts approximately three months, and patients will be monitored for several years afterward to evaluate the long-term effects of the treatment combination. Throughout the study, doctors will track how well the cancer responds to treatment and monitor any side effects that may occur.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial treatment preparation
Your participation begins after signing the informed consent form and completing initial medical assessments.
The study involves treatment with cabazitaxel (given through intravenous infusion) and radiation therapy to the pelvic area.
Your doctor will verify that you meet health requirements, including blood tests for liver function, kidney function, and blood cell counts.
Step 2
Treatment phase
You will receive JEVTANA (cabazitaxel) 60 mg through an intravenous infusion.
You will undergo pelvic radiation therapy sessions according to the treatment schedule.
Your treatment will include hormone therapy (ADT), which may have started up to 6 weeks before beginning the study.
Step 3
Regular monitoring - first 6 months
Blood tests will check your PSA levels (prostate-specific antigen) at 3 months.
Additional health assessments will occur at 6 months, including testosterone level testing.
You will complete quality of life questionnaires at the start and after 6 months of treatment.
Step 4
Long-term follow-up
Regular check-ups will continue yearly for up to 10 years.
Annual assessments will include blood tests, imaging scans, and quality of life questionnaires.
Side effects will be monitored at 1 year, 2 years, and 5 years after treatment.
The study will track any changes in your condition through regular imaging tests (CT scans and bone scans).

Who can join the trial?

18 criteria

Age between 18 and 75 years
Confirmed prostate cancer (adenocarcinoma) diagnosis through tissue examination
Must have at least 2 of these high-risk features:
- Gleason score 8 or higher (a measure of cancer aggressiveness)
- Cancer spread to tissues near the prostate (T3 or T4 stage)
- PSA level of 20 ng/mL or higher (prostate-specific antigen blood test)
- No spread of cancer to other parts of body
- No enlarged lymph nodes in the pelvic area (not larger than 1 cm)
- Good overall physical condition (ECOG score 0-1, meaning able to perform daily activities)
- Life expectancy greater than 10 years
- Adequate blood test results:
  - Platelet count at least 100,000 per microliter
  - Hemoglobin at least 9.0 g/dL
  - White blood cell count (neutrophils) at least 1,500 per microliter
  - Normal liver function tests
  - Good kidney function
  - Must use effective birth control during treatment and for 6 months after
  - Must be willing to attend all scheduled appointments and follow study procedures
  - Must sign an informed consent form
  - Must have health insurance or meet country requirements for clinical trials

Who cannot join the trial?

15 criteria

Prior treatment with chemotherapy or radiotherapy for prostate cancer
Previous surgery to the prostate (except for diagnostic biopsy)
Evidence of cancer spread beyond the prostate (metastatic disease)
Severe heart conditions including unstable angina (chest pain) or recent heart attack within 6 months
Uncontrolled hypertension (high blood pressure)
Active infections requiring treatment
Known allergies to study medications
Significant liver problems
Significant kidney problems
Other active cancers in the past 5 years (except treated non-melanoma skin cancer)
Mental conditions that could interfere with following study procedures
Any condition that, in the investigator's opinion, makes participation unsafe
Unable to give informed consent
Female patients (study is for male patients only)
Age below 18 years

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Verified sites

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

Cliniques Universitaires Saint-Luc
Responsive
Woluwe-Saint-Lambert, Belgium
Grand Hopital De Charleroi
Responsive
Charleroi, Belgium
Institut De Cancerologie De Lorraine
Responsive
Vandoeuvre Les Nancy, France

Trial locations

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Investigated drugs

Cabazitaxel A chemotherapy medication used to treat prostate cancer. It works by stopping cancer cells from dividing and growing. In this trial, it is used before the main treatment (neoadjuvant therapy) in patients with high-risk localized prostate cancer. ADT (Androgen Deprivation Therapy) A hormone therapy that reduces the levels of male hormones (androgens) in the body. This treatment helps slow down the growth of prostate cancer cells that depend on these hormones to grow. Radiation Therapy A treatment that uses high-energy radiation beams to target and destroy cancer cells in the prostate and pelvic area. This therapy is delivered to the specific area where the cancer is located to help control or eliminate the cancer while minimizing damage to surrounding healthy tissue.

Cabazitaxel

What is already known about the treatment

Cabazitaxel - A chemotherapy medication administered through intravenous infusion, belonging to the taxane family of drugs, which has been specifically developed for treating prostate cancer. It works by disrupting the microtubule network in cancer cells, preventing cell division and ultimately leading to cancer cell death. Cabazitaxel is primarily used in combination with other treatments, such as androgen deprivation therapy (ADT) and radiotherapy, for patients with high-risk localized prostate cancer who have significant risk factors for disease relapse. This medication represents an important advancement in prostate cancer treatment, particularly for cases where traditional therapies may be insufficient to prevent disease progression.

Investigated diseases

Prostate Cancer - A disease that develops in the prostate gland, which is part of the male reproductive system. It typically begins when normal prostate cells start to grow uncontrollably, forming a tumor. The cancer can remain localized within the prostate for many years, growing slowly in some cases. High-risk prostate cancer refers to tumors that show specific features indicating they may be more likely to grow and spread. The disease can affect urinary function and may cause other local symptoms as it progresses. The condition becomes more common as men age, with most cases diagnosed in men over 50.