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

3 1 1

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
Centre Hospitalier Regional Et Universitaire De Brest Brest France
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

Other Sites

Site Name City Country Status
University Hospital Ostrava Ostrava Czechia
Turku University Hospital Turku Finland
IRCCS Istituto Nazionale Tumori Fondazione Pascale Naples Italy
Az Maria Middelares Gent Gent Belgium
University Hospital Olomouc Olomouc Czechia
Centro Di Riferimento Oncologico Di Aviano Aviano Italy
Sykehuset Innlandet HF Brumunddal Norway
AZ Sint-Lucas & Volkskliniek Gent Belgium
Cgxqwqsof Uimtdubsceqklk Sjsiaofol Woluwe-Saint-Lambert Belgium
Hjmv Hlalqjqg Hague The Netherlands
Hjqsbepf Vugl djaguwnm Barcelona Spain
Frlpzeit nmokwwiyo Mmpzw a Hxiewkv Prague Czechia
Upaxgpnsylxoshlxjwgyw Twcwdfenf Aft Tuebingen Germany
Ixkhjbdz Rzbanukbc Pul Lx Synroi Dwl Txmtuc Dirh Agpaqii Incn Smffaa Meldola Italy
Upmsgwyqsahuubezj Dzycz Sklnq Dr Vizvys Verona Italy
Hiefsnva Conrey Dx Bavwcedyo Barcelona Spain
Chvuqta Uepifqrfjrcvkfmtphfy Bbvugc Kzw Berlin Germany
Hlucikml Uvryinstri Cxyeeik Hljjgvzy Helsinki Finland
Fllbbljr Ndytisljf Ksvqxyltp Vwytsjwhg Prague Czechia
Hjohylqj Cwxtsmu Sct Ckghje Madrid Spain
Ughyaqjmpzcrwxopzpiqt Hnwsjfypnd Auq Heidelberg Germany
Crszbzj Oomufxrzicv Cgexzp &nbfapy Sxrqoe Elqp Shumen Bulgaria
Snkjt Sztb Jxhn Ds Rlof Reus Spain
Ahkkpjg Uahkn Sxouctvsm Lvbpea Dv Bwjvgfg Bologna Italy
Cnhanl Ljmn Bguwnl Lyon France
Afigqkk Oehlzovftgi Pdqh Gcbjlnmk Xgyxh Bergamo Italy
Ccfsom hnpjdwojzsd uapswjqrhhyuy dy Lzngu Liege Belgium
Clvgbf Hfrlvbundfl Lyqv Stp Pierre Benite France
Hqrxghbp Ufwmnwdimdrhl Pbddje Dn Hvufuy Dh Mfxoaewdoiq Majadahonda Spain
Utazhymwqu Ddcar Sjkef Dm Bmixvyv Brescia Italy
Fsfdgbqxz Imylujwwm Vnwlyzgocn Dh Osiyxkgnn Valencia Spain
Asgvzrbw Zbchpxeydt Gphfwacgz Kortrijk Belgium
Caktkgv Oxhuaqxolgc Cdtkzu Plmdkkg Emzb Plovdiv Bulgaria
Ifjfzqmn Dw Cjptryrqqjai Sbsgslvddv Ehaltu STRASBOURG, Alsace France
Orqigokb Olzpmehgur Irhypjo Budapest Hungary
Cyltwpix Vmhavv Huhs Le Mans France
Hch Nnwh Lille France
Inhxbklv Jjpjy Bgytyo Brussels Belgium
Akkjewc Ojoygwfuunbanhaiauphxinmr Syj Lpahe Gvsokra Orbassano Italy
Nbhkhev Olgbrkmlhrs Ufela Bratislava Slovakia
Mvjqjks Mfuuenk Clsqxu Amersfoort The Netherlands
Mlwuswim ssgkwm Presov Slovakia
Hewkpjao Uxvlbyfhifmvw Lvgxd Awngbat Lugo Spain
Genvuc Ulutgonfis Fddyevgiq Frankfurt Germany
Jemf Fniuen Dnqftlhir Kawhmv Ee Rdbtogxokhaxlr Budapest Hungary
Adstamg Ulb Tahngzi Sxl Ejc Arezzo Italy
Atdzqwr Sosak Saztszssl Trmrywrfplcd De Ctcwmgz Cremona Italy
Abfkamj Pfgesgyoewb Ppn I Sumybwt Sdjljsbp Trento Italy
Ctdl Svrgwgdd Dfoyi Szvvggpphl San Giovanni Rotondo Italy
Ssdbnqdcxyiaa Uzkpykpy Srhtl Fyktvcrhur Ml Tsrrkj Tzsxioreasj Mi Plz Gqm Nuertingen Germany
Vooxodqlzknmguum Oyrmjehmugm Uqobj anks Kosice Slovakia
Caudeg Hcqndarqokg Plwqt Sjjrqqyxoodrtg Saint-Gregoire France
Mz Azcxptdn Cxawjg Cahtcd Madrid Spain
Mmabszabavkk Hihnfvdr Fof Adpsha Trimmospostvw Hrpjxjrq Lyqv Panagyurishte Bulgaria
Asdqfak Xgwqd Ajlrzxaqsdix Umxcauvvzvrab Dx Mxweywq Fhptooox Pusgogs Manresa Spain
Idbnvgfl Gxcgtlv Reims France
Plmwjbhp Uzylnwjanx Augkgwqgyc samkho Trencin Slovakia
Hvbdhlze Umixaouhjwtho Hsskuuea Thvdf y Pkwzgx Icpmotft Cnreph ddtoawgbobebhsowf (tdip Badalona Spain
Hmzztov Budebt &otaffm Cblyjl Bhdwxyi 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
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.

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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