Study of talazoparib and enzalutamide combination in men with DDR gene mutated metastatic castration-sensitive prostate cancer

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What is this study about?

This study focuses on men with metastatic castration-sensitive prostate cancer who have specific genetic mutations in their DNA repair genes. The research examines the effectiveness of combining two medications: talazoparib and enzalutamide. Metastatic means the cancer has spread from the prostate to other parts of the body, while castration-sensitive means the cancer still responds to treatments that lower testosterone levels.

The purpose of this study is to determine if adding talazoparib to enzalutamide treatment works better than using enzalutamide with a placebo in treating this type of prostate cancer. The study uses DNA repair gene mutations testing to identify suitable participants. During the study, participants will receive either the combination of talazoparib and enzalutamide or enzalutamide with a placebo.

Throughout the treatment period, which may last up to 24 months, participants will continue to receive hormone therapy that reduces testosterone levels. The study will monitor how the cancer responds to treatment through regular medical examinations and imaging tests. These tests will help determine if the cancer is stable, improving, or getting worse.

1 Initial medication assignment

You will be randomly assigned to one of two treatment groups:

Group 1: Talazoparib capsules + Enzalutamide (Xtandi) 40 mg soft capsules

Group 2: Placebo capsules + Enzalutamide (Xtandi) 40 mg soft capsules

Both medications are taken by mouth

2 Hormone therapy requirement

You must continue taking your prescribed hormone therapy (ADT) throughout the entire study

This involves regular injections of medication that lowers testosterone levels, unless you have had previous surgery to remove both testicles

3 Regular health monitoring

Your cancer progression will be monitored through regular imaging scans

Doctors will check for changes in both soft tissue using CT or MRI scans

Bone scans will be performed to check for bone-related changes

4 Physical condition assessment

Your overall physical condition will be regularly evaluated using the ECOG scale

This scale measures your ability to perform daily activities and self-care

5 Study duration

The study continues until August 2027

Your participation may end earlier if your condition changes or as determined by your doctor

Who Can Join the Study?

  • Must have confirmed prostate cancer (specifically adenocarcinoma type) that has been verified through tissue examination
  • Must undergo testing to confirm specific genetic mutations (called DDR gene mutations) through blood sample or tissue analysis
  • Must be receiving ongoing hormone therapy (ADT) with specific medications, or have had surgical removal of testicles (bilateral orchiectomy). The hormone therapy must continue throughout the study
  • Must have cancer that has spread (metastatic disease) confirmed by:
    • Bone scan showing spread to bones, or
    • CT or MRI scan showing spread to soft tissues
  • Must have good physical functioning ability, scoring either 0 (fully active) or 1 (restricted in physically strenuous activity) on the ECOG performance scale
  • Must be male
  • Must be an adult (18 years or older)
  • Cannot have cancer spread limited to only pelvic lymph nodes
  • Cannot have a condition called superscan (a specific type of bone scan result)

Who Cannot Join the Study?

  • Prior treatment with PARP inhibitors (medications that block DNA repair in cancer cells)
  • Known active brain or spinal cord metastases (cancer that has spread to brain or spine)
  • Significant heart conditions, including:
    • Heart attack within past 6 months
    • Uncontrolled high blood pressure
    • Unstable heart rhythm problems
  • Severe liver problems or active liver disease
  • Other active cancers requiring treatment (except non-melanoma skin cancer)
  • History of seizures or conditions that may cause seizures
  • Major surgery within 4 weeks before starting the study
  • Any serious medical condition that could interfere with study participation
  • Unable to swallow oral medications
  • Known allergic reactions to the study medications
  • Participation in other clinical trials within 4 weeks before this study
  • Female patients (study is only for male participants)
  • 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
Hospital Universitario Y Politecnico La Fe Valencia Spain
Hospital Universitario De Navarra Pamplona Spain
Institut De Cancerologie De Lorraine Vandoeuvre Les Nancy France
Universitaetsmedizin Goettingen Goettingen Germany
Hospital Clinico San Carlos Madrid Spain
Universitaetsklinikum Heidelberg AöR Heidelberg Germany
Centre Hospitalier Regional Et Universitaire De Brest Brest France

Other Sites

Site Name City Country Status
Orszagos Onkologiai Intezet Budapest Hungary
Centro Di Riferimento Oncologico Di Aviano Aviano Italy
Azienda Socio Sanitaria Territoriale Di Cremona Cremona Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale Naples Italy
Azienda Provinciale Per I Servizi Sanitari Trento Italy
Casa Sollievo Della Sofferenza San Giovanni Rotondo Italy
Centre hospitalier universitaire de Liege Liege Belgium
Centre Hospitalier Lyon Sud Pierre Benite France
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Az Maria Middelares Gent Gent Belgium
Fundacion Instituto Valenciano De Oncologia Valencia Spain
Studienpraxis Urologie Susan Feyerabend MD Tilman Todenhoefer MD PhD GbR Nuertingen Germany
Algemeen Ziekenhuis Groeninge Kortrijk Belgium
AZ Sint-Lucas & Volkskliniek Gent Belgium
Vychodoslovensky Onkologicky Ustav a.s. Kosice Slovakia
Complex Oncological Center Plovdiv EOOD Plovdiv Bulgaria
Centre Hospitalier Prive Saint-Gregoire Saint-Gregoire France
MD Anderson Cancer Center Madrid Spain
Multiprofile Hospital For Active Treatment-Uni Hospital Ltd. Panagyurishte Bulgaria
Althaia Xarxa Assistencial Universitaria De Manresa Fundacio Privada Manresa Spain
Institut Godinot Reims France
Privatna Urologicka Ambulancia s.r.o. Trencin Slovakia
Haga Hospital Hague The Netherlands
Institut De Cancerologie Strasbourg Europe STRASBOURG, Alsace France
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Azienda Ospedaliero-Universitaria San Luigi Gonzaga Orbassano Italy
Universita’ Degli Studi Di Verona Verona Italy
Hospital Clinic De Barcelona Barcelona Spain
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Narodny Onkologicky Ustav Bratislava Slovakia
Meander Medical Center Amersfoort The Netherlands
Fakultni Nemocnice Kralovske Vinohrady Prague Czechia
Turku University Hospital Turku Finland
Medikard s.r.o. Presov Slovakia
Hospital Universitario Lucus Augusti Lugo Spain
Complex Oncological Center – Shumen EOOD Shumen Bulgaria
Salut Sant Joan De Reus Reus Spain
Jahn Ferenc Del-Pesti Korhaz Es Rendelointezet Budapest Hungary
University Hospital Olomouc Olomouc Czechia
Azienda USL Toscana Sud Est Arezzo Italy
Sykehuset Innlandet HF Brumunddal Norway
Universita Degli Studi Di Brescia Brescia Italy
Clinique Victor Hugo Le Mans France
University Hospital Ostrava Ostrava Czechia
Hopital Bichat – Claude Bernard Paris France
Cdqfjltzr Uuaqiiyygrnnnw Sslbdqtld Woluwe-Saint-Lambert Belgium
Cydfgi Lhff Btbssc Lyon France
Hvc Nnqc Lille France
Ispidzbo Jnqnk Bmqimv Brussels Belgium
Fhotqpqt nccgedbyx Mlciu a Heouclp Prague Czechia
Iuvedvnq Rnvrflnip Plu Ly Sxxojp Dtd Tocdms Dwkq Axmszgf Imal Sifsej Meldola Italy
Hchijskp Uceksrgvuw Cqsvrlb Hijvsvks Helsinki Finland
Gtrxty Urlzanlhqf Fyiqfhusc Frankfurt Germany
Atjclbt Ugzjn Sapsaippw Leikra Do Bhnqqjv Bologna Italy
Aqxjxwo Olkfirckqkp Pkua Ggwtxujb Xwobe Bergamo Italy
Hqamrpqn Uqfzaspiextqt Hdhclrhh Tovmo y Pzjvlc Iwvkcydy Czxraj dwragwoarqbipawhs (cuqa Badalona Spain
Hbwvnkxf Vlzt dgkaezaz Barcelona Spain

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
22.04.2024
Bulgaria Bulgaria
Not recruiting
22.04.2024
Czechia Czechia
Not recruiting
22.04.2024
Finland Finland
Not recruiting
22.04.2024
France France
Not recruiting
22.04.2024
Germany Germany
Not recruiting
22.04.2024
Hungary Hungary
Not recruiting
22.04.2024
Italy Italy
Not recruiting
22.04.2024
Norway Norway
Not recruiting
22.04.2024
Slovakia Slovakia
Not recruiting
22.04.2024
Spain Spain
Not recruiting
22.04.2024
The Netherlands The Netherlands
Not recruiting
22.04.2024

Trial locations

Investigated drugs:

Talazoparib is a medication that belongs to a class of drugs called PARP inhibitors. It works by blocking an enzyme that helps repair damaged DNA in cancer cells, which can help stop cancer cells from growing and dividing. In this trial, it is being studied for treating prostate cancer that has specific genetic mutations.

Enzalutamide is a hormone therapy medication used to treat prostate cancer. It works by blocking the effects of testosterone and other male hormones that can stimulate prostate cancer growth. This medication helps to slow down or stop the growth of prostate cancer cells.

Investigated diseases:

Metastatic Castration-sensitive Prostate Cancer – A condition where prostate cancer has spread beyond the prostate gland to other parts of the body, but still responds to treatments that lower testosterone levels. In this type of cancer, the tumor cells continue to be dependent on male hormones (androgens) for their growth. The cancer typically spreads to lymph nodes, bones, or other organs while maintaining its sensitivity to hormone therapy. This form of prostate cancer represents a stage where the disease has become metastatic but remains responsive to treatments that reduce testosterone levels in the body.

Trial ID:
2024-510809-28-00
Protocol code:
C3441052
NCT ID:
NCT04821622
Trial Phase:
Therapeutic confirmatory (Phase III)

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