A Study of Cabazitaxel and Pelvic Radiation Therapy Combined with Hormone Treatment for Patients with High-Risk Localized Prostate Cancer

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What is this study about?

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.

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.

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.

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.

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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Institut Gustave Roussy Villejuif France
Oncopole Claudius Regaud Toulouse France
Centre Jean Perrin Clermont Ferrand France
Institut De Cancerologie De Lorraine Vandoeuvre Les Nancy France
Clinique Pasteur Toulouse France
Hospital Universitario De Salamanca Salamanca Spain
Centre Hospitalier Regional Et Universitaire De Brest Brest France

Other Sites

Site Name City Country Status
Hopital Tenon Paris France
Centre Hospitalier Universitaire De Nimes Nimes France
Centre Hospitalier Universitaire De Poitiers Poitiers France
Hospital Del Mar Barcelona Spain
Grand Hopital De Charleroi Charleroi Belgium
Centre Hospitalier Prive Saint-Gregoire Saint-Gregoire France
Althaia Xarxa Assistencial Universitaria De Manresa Fundacio Privada Manresa Spain
Clinique Pasteur Lanroze Brest France
Hopital Prive Toulon Hyeres Sainte Marguerite Hyeres France
CHP Sainte Marie Osny Osny France
Consorci Sanitari De Terrassa Terrassa Spain
Centre Hospitalier Universitaire d’Orléans Orléans France
Hospital Clinic De Barcelona Barcelona Spain
Centre Hospitalier Metropole Savoie Chambery France
Hospital Universitario Lucus Augusti Lugo Spain
Clinique Ambroise Pare Beuvry France
CHC MontLegia Liege Belgium
Hopital Prive Des Cotes D’armor Plerin France
Unite De Recherche Clinique HIA Begin Saint-Mande France
Hopital Prive Clairval Marseille France
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Institut de Cancérologie de l’Ouest Saint-Herblain France
Centre Francois Baclesse Caen France
Centre De Lutte Contre Le Cancer Eugene Marquis Rennes France
Oncoradio Centre Oncogard Nimes France
Hospital Universitario Virgen De La Victoria Malaga Spain
Cbxtjnchd Ukyztylffvevqh Sxdpngxxy Woluwe-Saint-Lambert Belgium
Cmhyxx Luoc Bxcuzc Lyon France
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Hilrtbkn Utchrtaxlhqss Mkyui Tgbrghep Terrassa Spain
Cdzqsl Aczpvmc dp Cvcgipmcklze Mougins France
Cadqvy Hrgfpmwrvih Ea Uwxcvnddqcifc De Llddczd Limoges France
Acqpohtqla Phswwiuh Hevkxfkh Dh Ptqja Paris France
Avdtnibobw Pbplweju Hupxezcv Dz Mivzimhyi Marseille France
Bgknyaeb Uiqzyhuowh Hgsclrpq Cyedoz Besançon France
Cagkzs Harhvgnngab Rafrlixs Uxopncvblbqhm Dd Trxsi Tours France
Gpzyxf Hltfcjealki Uzgvxvvkgtafx Pgmqv Pdhhxkwcglf Ey Nbnwqpxtyffu Paris France
Hjzceqxh Ufvdpwjpknult Hvplftzp Tmsop y Pabmti Itaqbcjx Cvsuja dxytgkkvxujwfnxbo (pexh Badalona Spain
Iwsgublc dd Craifiycgjzz Hcznlievcav Ujnskvljetozk dr Skqia Eutzyvb (dymjxrd Saint Priest En Jarez France
Htlfyrvb Vrpc ddhzoacr Barcelona Spain
Idqboczs Pylulrerkkrsukw Chfrzd Cemrko Marseille France
Ixagrgjt Cushu Paris France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
16.12.2013
France France
Not recruiting
16.12.2013
Spain Spain
Not recruiting
16.12.2013

Trial locations

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.

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.

Trial ID:
2024-517622-25-00
NCT ID:
NCT01952223
Trial Phase:
Therapeutic confirmatory (Phase III)

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