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Study on Enzalutamide and Leuprorelin Acetate for Men with High-Risk Nonmetastatic Prostate Cancer After Treatment

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What is this study about?

This clinical trial is focused on studying treatments for prostate cancer, specifically in men with high-risk nonmetastatic prostate cancer that is progressing after initial therapy. The study involves three different treatment approaches: a combination of enzalutamide and leuprolide, enzalutamide alone, and leuprolide alone. Enzalutamide is a medication that helps block the effects of male hormones that can promote the growth of cancer cells, while leuprolide is used to lower the levels of these hormones in the body.

The purpose of the study is to evaluate the safety and effectiveness of these treatments. Participants will be randomly assigned to one of the treatment groups and will receive their assigned treatment for a period of up to 90 days. The study will monitor the participants’ health and the progression of their prostate cancer during this time. The trial aims to determine which treatment approach is most effective in managing the disease.

Throughout the study, participants will undergo regular check-ups and assessments to track their response to the treatment. The study will also compare the outcomes of the different treatment groups to understand the benefits and potential side effects of each approach. This research is important for improving treatment options for men with high-risk nonmetastatic prostate cancer.

1 initial treatment phase

Upon joining the study, the patient will begin the initial treatment phase. This involves the administration of medications designed to evaluate their effectiveness and safety in treating high-risk nonmetastatic prostate cancer.

The patient will receive leuprorelin acetate through subcutaneous injection. This medication is used to manage prostate cancer by reducing testosterone levels, which can help slow the growth of cancer cells.

2 medication administration

The patient will be randomly assigned to one of the following treatment groups: enzalutamide plus leuprolide, enzalutamide monotherapy, or placebo plus leuprolide.

If assigned to the enzalutamide group, the patient will take Xtandi (enzalutamide) in the form of 40 mg soft capsules orally. The frequency and duration of this medication will be determined by the study protocol.

3 monitoring and follow-up

Throughout the study, the patient’s health and response to the treatment will be closely monitored. This includes regular check-ups and tests to assess the effectiveness of the medication and to identify any side effects.

The primary goal is to evaluate the efficacy of the combination of enzalutamide plus leuprolide compared to placebo plus leuprolide, as measured by metastasis-free survival (MFS).

4 completion of study

The study is expected to continue until October 31, 2026. Upon completion, the data collected will be analyzed to determine the safety and effectiveness of the treatments.

The patient will be informed of the study results and any potential implications for their ongoing care.

Who Can Join the Study?

  • Must be 18 years or older and willing to give permission to participate in the study.
  • Throughout the study, the patient and his female partner who can have children must use 2 acceptable methods of birth control. One method must be a condom. Other options include:
    • Female partner using birth control pills, injections, or implants.
    • Female partner using an intrauterine device (IUD).
    • Female partner using additional barrier methods like a contraceptive sponge or cap with sperm-killing products.
    • Female partner having had a tubal ligation (surgery to prevent pregnancy) at least 6 months before the study.
    • Patient having had a vasectomy or other procedure that causes infertility at least 6 months before the study.
  • Must use a condom if having sex with a pregnant woman during the study.
  • Must agree not to donate sperm from the first dose of the study drug until 3 months after the last dose.
  • Must have a confirmed diagnosis of prostate cancer from a tissue sample, without certain specific cell types.
  • Prostate cancer must have been initially treated with surgery or radiation therapy, or both, with the aim to cure. Previous use of prostate cryoablation (freezing treatment) is allowed but not considered a cure for this study.
  • Must have a PSA (Prostate-Specific Antigen) doubling time of 9 months or less, as calculated by the study sponsor.
  • PSA level must be at least 1 ng/mL for those who had surgery (with or without radiation) and at least 2 ng/mL above the lowest level for those who had only radiation therapy.
  • Serum testosterone level must be at least 150 ng/dL at the start of the study.
  • Must have an ECOG (Eastern Cooperative Oncology Group) performance status of 0 or 1, which means fully active or restricted in physically strenuous activity but able to carry out light work.
  • Must have an estimated life expectancy of at least 12 months.
  • Must be able to swallow the study drug and follow the study requirements.

Who Cannot Join the Study?

  • Patients who are not male cannot participate in the study.
  • Patients who are part of a vulnerable population, meaning they might need special protection or care, cannot participate in the study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Medical University Of Vienna Vienna Austria
Hospital Universitario De Salamanca Salamanca Spain
Centre Hospitalier Universitaire De Lille Lille France
University Hospital Maastricht Maastricht The Netherlands
Comite Entreprise Paul Papin Angers France

Other Sites

Site Name City Country Status
Centre Hospitalier Departemental Vendee La Roche sur Yon France
Soedersjukhuset AB Stockholm Sweden
Karolinska University Hospital Solna Sweden
Sygehus Lillebaelt Vejle Sygehus Vejle Denmark
Universidade De Santiago De Compostela Santiago De Compostela Spain
Rigshospitalet Copenhagen Denmark
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Universitario 12 De Octubre Madrid Spain
Hospital Del Mar Barcelona Spain
Servei De Salut De Les Illes Balears Palma Spain
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen Gothenburg Sweden
Fundacion Instituto Valenciano De Oncologia Valencia Spain
Univerzitna Nemocnica Martin Martin Slovakia
Uniklinikum Salzburg Salzburg Austria
Pohjois-Pohjanmaan hyvinvointialue Oulu Finland
Uroexam spol. s r.o. Nitra Slovakia
Azienda Ospedaliero-Universitaria San Luigi Gonzaga Orbassano Italy
Catharina Ziekenhuis Stichting Eindhoven The Netherlands
Norrlands University Hospital Umea Sweden
Medikard s.r.o. Presov Slovakia
Hospital Universitari De Girona Doctor Josep Trueta Girona Spain
Unite De Recherche Clinique HIA Begin Saint-Mande France
Azienda Unita Sanitaria Locale Della Romagna Faenza Italy
Pirkanmaan hyvinvointialue Tampere Finland
Azienda Socio Sanitaria Territoriale Di Cremona Cremona Italy
Hospital Foch Suresnes France
Azienda Provinciale Per I Servizi Sanitari Trento Italy
San Camillo Forlanini Hospital Rome Italy
Vychodoslovensky Onkologicky Ustav a.s. Kosice Slovakia
Centre Hospitalier Prive Saint-Gregoire Saint-Gregoire France
MD Anderson Cancer Center Madrid Spain
Wojewodzki Szpital Specjalistyczny Im. Janusza Korczaka W Slupsku Sp. z o.o. Slupsk Poland
Althaia Xarxa Assistencial Universitaria De Manresa Fundacio Privada Manresa Spain
Clinique Pasteur Lanroze Brest France
EMC Instytut Medyczny S.A. Poznan Poland
Iwrlxtie Rmjcvqche Pnm Ls Sykmiu Dau Thhfwv Dfoa Anvwagb Ihsz Sjechv Meldola Italy
Agaelfymj Ueu Amsterdam The Netherlands
Huygaemr Utusftfvsu Cejneov Hrmurwxw Helsinki Finland
Uafgpewuqwfzjs Cgkarvp Khycitvoj Gdansk Poland
Ofugwybkhgpgba Luln Geyh Linz Austria
Ulcjspscphzd Mcvpyql Cdtpwvo Gzytwnkas Groningen The Netherlands
Hlubdsmc Utvimwsnmoxjw Dc Le Puwbyovs Madrid Spain
Pgbc Tqyjn Hbhcapnu Uezrtvcorowt Sabadell Spain
Imlxqwqz Rvjixzqu Dv Cyzazq Dy Mlwgwwpcczq Montpellier France
Etbfkbbdrubwmuhgn hlefckqifgedaoc Seinajoki Finland
Cftojj sjfzry Bratislava Slovakia
Uveqrsabcuyllubsgalzp Öhsohk Orebro Sweden
Alvplpnlee swrbrdbdr Uppsala Sweden
Swwfqg Ufxpjgrqgwkrjvzdzjt Mgjaq Malmo Sweden
Kloyvcnitstxdzpmnh Cpragzs Upnxvfnmvbw Sn z ovb Torun Poland
Supegcigee hblsqgramccghso Pori Finland
Agrhshivdj Pvjdtytf Hanusozr Da Prlfk Paris France
Axmeby Ubnqutzrtm Heruvdkr Aarhus Denmark
Ivmrmmjh Mnbonyewta Mirsvbkdmk Paris France

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

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
05.10.2015
Denmark Denmark
Not recruiting
05.10.2015
Finland Finland
Not recruiting
05.10.2015
France France
Not recruiting
05.10.2015
Italy Italy
Not recruiting
05.10.2015
Poland Poland
Not recruiting
05.10.2015
Slovakia Slovakia
Not recruiting
05.10.2015
Spain Spain
Not recruiting
05.10.2015
Sweden Sweden
Not recruiting
05.10.2015
The Netherlands The Netherlands
Not recruiting
05.10.2015

Trial locations

Investigated Drugs:

Enzalutamide is a medication used in this trial to treat men with high-risk nonmetastatic prostate cancer. It works by blocking the effects of male hormones that can promote the growth of cancer cells. In this study, enzalutamide is being tested both on its own and in combination with another medication to see how effective it is in slowing down or stopping the progression of prostate cancer.

Leuprolide is another medication used in this trial. It is a type of hormone therapy that lowers the levels of testosterone in the body. Testosterone can help prostate cancer cells grow, so by reducing its levels, leuprolide aims to slow down or stop the growth of the cancer. In this study, leuprolide is used in combination with enzalutamide to evaluate the effectiveness of this treatment approach.

Investigated Diseases:

Prostate Cancer – Prostate cancer is a disease where cells in the prostate gland grow uncontrollably. The prostate is a small gland in men that produces seminal fluid. As the cancer progresses, it may spread to nearby tissues or other parts of the body. Early stages often have no symptoms, but as it advances, it can cause urinary problems, pelvic discomfort, or bone pain. The growth rate of prostate cancer can vary, with some types growing slowly and others more aggressively. Monitoring and understanding the progression is crucial for managing the disease effectively.

Trial ID:
2024-513521-23-00
Protocol code:
C3431004/MDV3100-13
NCT ID:
NCT02319837
Trial Phase:
Therapeutic confirmatory (Phase III)

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