Study on Talazoparib and Enzalutamide for Patients with Metastatic Castration-Resistant Prostate Cancer

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What is this study about?

This clinical trial is focused on studying a type of prostate cancer known as metastatic castration-resistant prostate cancer (mCRPC). This is a form of prostate cancer that continues to grow and spread even when the amount of testosterone in the body is reduced to very low levels. The study is testing a combination of two medications: talazoparib and enzalutamide. Talazoparib is a medication that may help stop cancer cells from repairing themselves, while enzalutamide is used to block the effects of testosterone, which can fuel the growth of prostate cancer cells.

The purpose of the study is to determine if the combination of talazoparib and enzalutamide is more effective than enzalutamide alone in treating mCRPC. Participants in the study will be randomly assigned to receive either the combination of talazoparib and enzalutamide or a placebo with enzalutamide. The study will be conducted over a period of up to 24 months, during which participants will take the medications orally in the form of capsules. The study aims to see if this combination can help prolong the time before the cancer progresses, as assessed by medical imaging techniques.

Throughout the study, participants will have regular check-ups and tests to monitor their health and the effects of the treatment. The study will also look at the safety of the medication combination and how it is processed in the body. This research is important for understanding new ways to treat mCRPC and potentially improve outcomes for patients with this challenging form of cancer.

1 joining the study

Upon joining the study, participants will be required to provide a signed and dated informed consent document. This document confirms that all relevant aspects of the study have been explained and understood.

Participants must meet specific criteria, such as being at least 18 years old, having a life expectancy of at least 12 months, and being able to swallow the study treatment.

2 initial assessments

Participants will undergo initial assessments to confirm eligibility. This includes confirming a diagnosis of metastatic castration-resistant prostate cancer and ensuring ongoing androgen deprivation therapy.

Additional tests may include blood tests, imaging scans, and assessments of disease progression.

3 treatment phase part 1

In Part 1 of the treatment phase, the starting dose of talazoparib in combination with enzalutamide will be determined. Both medications are taken orally.

Participants will be monitored for safety events and the effects of the medication.

4 treatment phase part 2

In Part 2, participants will receive either talazoparib with enzalutamide or a placebo with enzalutamide. This phase is double-blind, meaning neither participants nor researchers know who receives the active medication.

The goal is to assess the effectiveness of the medication in prolonging the time without disease progression.

5 ongoing monitoring

Throughout the study, participants will have regular visits for monitoring. This includes laboratory tests, imaging scans, and assessments of health status.

Participants must comply with scheduled visits and study procedures.

6 end of study

The study is estimated to end by December 31, 2025. Participants will have a final assessment to evaluate the overall impact of the treatment.

Participants will be informed about the results and any further steps if necessary.

Who Can Join the Study?

Must be at least 18 years old. In Japan, must be at least 20 years old.
Must have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale, which measures how well you can perform daily activities.
Must have a life expectancy of at least 12 months, as determined by the study doctor.
Must be able to swallow the study medication and have no known allergies to the study drugs or their ingredients.
If sexually active and capable of ejaculating, must agree to use a condom during sex from the first dose of study treatment until 4 months after the last dose. If the partner is a woman who can become pregnant, she must also use an additional highly effective form of birth control during this time.
Must agree not to donate sperm from the first dose of study treatment until 4 months after the last dose.
Must provide a signed and dated informed consent form, indicating that you understand the important details of the study.
Must be willing and able to attend scheduled visits, follow the treatment plan, and undergo laboratory tests and other study procedures.
Must have a confirmed diagnosis of prostate cancer that is not of the small cell or signet cell type. If there is no previous diagnosis, a new biopsy must confirm the diagnosis and support biomarker analysis.
Must have metastatic castration-resistant prostate cancer (mCRPC) that is either asymptomatic or causes only mild symptoms, with a pain score of less than 4 on a specific questionnaire.
For Part 2 of the study (optional for Part 1): Must have an assessment of DDR mutation status through blood, tissue, or historical analysis, with sponsor approval. Biopsies of certain organs are not allowed solely for study eligibility.
For Part 2 of the study (optional for Part 1): Must consent to provide a saliva sample for genetic testing, unless prohibited by local regulations.
Must be surgically or medically castrated, with a serum testosterone level of 50 ng/dL or lower at screening. If not surgically castrated, ongoing hormone therapy must have started at least 4 weeks before the study and continue throughout.
Must have metastatic disease in the bone or soft tissue, as shown by scans done within 6 weeks before the study. Measurable soft tissue disease is not required.
Must have progressive disease at study entry, shown by one or more of the following: rising prostate-specific antigen (PSA) levels, soft tissue disease progression, or bone disease progression.
Use of bone-strengthening medications like bisphosphonates or denosumab before the study is allowed but not required.

Who Cannot Join the Study?

Patients who have a different type of cancer other than Metastatic Castration-resistant Prostate Cancer.
Patients who are not male, as the study is only for male participants.
Patients who are considered part of a vulnerable population, which means they might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Institut Gustave Roussy	Villejuif	France
Hôpital Européen Georges-Pompidou	Paris	France
Kuopio University Hospital	Kuopio	Finland

Other Sites

Site Name	City	Country
University Hospital Ostrava	Ostrava	Czechia
Hospital Da Luz S.A.	Lisbon	Portugal
Fakultni Nemocnice Hradec Kralove	Novy Hradec Kralove	Czechia
Karolinska University Hospital	Solna	Sweden
Semmelweis University	Budapest	Hungary
Turku University Hospital	Turku	Finland
IRCCS Istituto Nazionale Tumori Fondazione Pascale	Naples	Italy
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.	Porto	Portugal
CHU Bordeauxt	Bordeaux	France
AZ Sint-Lucas & Volkskliniek	Gent	Belgium
Europejskie Centrum Zdrowia Otwock Sp. z o.o.	Otwock	Poland
HUS Helsinki University Hospital	Helsinki	Finland
Hujwlwru Vhmz dcgzjonm	Barcelona	Spain
Igpmrfve Rqspiiyne Pgz Lb Skldxg Dqh Tssofx Dajn Ayupnmx Iomk Saewll	Meldola	Italy
Aycqppqj Uzbscoehnp Hpcvfchk	Lorenskog	Norway
Hxqpigtc Cnpxfg Db Bulsxuwwa	Barcelona	Spain
Uydkivbtbdwgnpgsuscob Dqfhzmgrpir Ajv	Duesseldorf	Germany
Ukoywbdlrb Cmryvhpg Hvmjkhym Vxbcoe Dw Lw Adbjzajx	Murcia	Spain
Unulcjevsrfj Dq Sntngfos Dx Csxpyxiqby	Santiago De Compostela	Spain
Utwynhqfbprzzymwomznn Mryxrqbv Ahs	Munster	Germany
Uvmkedxhyldzsxkurluor Hxljfdxaly Axk	Heidelberg	Germany
Csfwzl Livo Bvqxua	Lyon	France
Uupxyodlamac Zbwujcknrh Glnw	Gent	Belgium
Hgwriqbg Udbttijlgaauq 1t Dv Oqzsocf	Madrid	Spain
Hdegidac Uqsywoendjtgg Dh Lu Pervilmw	Madrid	Spain
Ifkgmgta Ctyfwd Dhabqpfylymfospwe	L'hospitalet De Llobregat	Spain
Qlwxz Soevjm Cbivsdnyy Hfwaflno &issmko Siepczjathp Ufjzpiabyx Hjnfmtdh &mwzjpu Vtwwkbw Gspmzbvrloqhghceba	Gothenburg	Sweden
Afhaumep Znsnyzabjc Glikivrpk	Kortrijk	Belgium
Savpbiyg Pxdbepjfq Slb z owme	Gdynia	Poland
Cqer Cudwlu Cbuqfob Awosjtkeo Bgjhy Aawmryquvk	Braga	Portugal
Obii Utcsdpniqk Hiocfvgu	Oulu	Finland
Iinxmbdc Dl Cuvmougyjizr Slslyytbzw Ezxyht	STRASBOURG, Alsace	France
Mibtpegwi siaulh	Horovice	Czechia
Djdwshbn Ob	Helsinki	Finland
Cpzbsgtc Vsvbfl Hsih	Le Mans	France
Paugvvmpxzy Lepxpcvn &bggruaqshpczyupigpg Ronyd Kfuuxkwriwl	Konin	Poland
Adwkpvk Ouujqfqmwebtktnwlewfuipvf Sca Lwway Gcgkpnc	Orbassano	Italy
Cqiisbzuivzj Cbrlcwji Cpyqjd	Lisbon	Portugal
Urbjpeogzp Oj Pvtl	Pecs	Hungary
Pmjwfgfuih hwrschjuvzklzeh	Tampere	Finland
Ahboxfj Stepy Sskmkttbs Tsbwnakhhtia Dw Cpqsxnz	Cremona	Italy
Hvdchilu Fcbt	Suresnes	France
Azxiwqs Pmluakwvmrl Plb I Sciicfy Scmpqfxx	Trento	Italy
Rdctuu Vnsrubbwiniuc	Umea	Sweden
Sam Olrxw Hbrivaxo Hq	Trondheim	Norway
Sgodmsfwwmrmy Ueoturbz Svklo Fksrvagvqu Mx Tkvaje Thukradxpbp My Pwx Gsv	Nuertingen	Germany
Ml Aymbgwue Cgjpor Cjqyyw	Madrid	Spain
Cwdifcps Skmiyhydeeca Oknnsqflb (khjeo	Ottignies	Belgium

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	18.12.2017
Czechia	Not recruiting	18.12.2017
Finland	Not recruiting	18.12.2017
France	Not recruiting	18.12.2017
Germany	Not recruiting	18.12.2017
Hungary	Not recruiting	18.12.2017
Italy	Not recruiting	18.12.2017
Norway	Not recruiting	18.12.2017
Poland	Not recruiting	18.12.2017
Portugal	Not recruiting	18.12.2017
Spain	Not recruiting	18.12.2017
Sweden	Not recruiting	18.12.2017

Trial locations

Investigated Drugs:

Talazoparib is a medication used in this clinical trial to treat prostate cancer that has spread to other parts of the body and is resistant to standard hormone therapy. It works by blocking a specific protein in cancer cells, which helps to stop the cancer from growing and spreading. In this study, talazoparib is being tested to see if it can improve the outcomes for patients when used together with another medication.

Enzalutamide is another medication used in this trial. It is a type of hormone therapy that helps to slow down the growth of prostate cancer by blocking the effects of male hormones that can promote cancer growth. Enzalutamide is already used to treat prostate cancer, and in this study, it is being combined with talazoparib to see if the combination is more effective than enzalutamide alone.

Metastatic Castration-resistant Prostate Cancer – This is a type of prostate cancer that continues to grow and spread to other parts of the body despite low levels of testosterone. It typically progresses by spreading to bones and lymph nodes, causing pain and other symptoms. The cancer cells in this condition are resistant to treatments that lower testosterone, a hormone that usually fuels prostate cancer growth. Over time, the disease can lead to complications such as bone fractures and spinal cord compression. The progression of the disease is often monitored through imaging tests and blood markers. As the cancer advances, it may cause more severe symptoms and impact daily activities.

Trial ID:

2023-509087-20-00

Protocol code:

C3441021

NCT ID:

NCT03395197

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Talazoparib and Enzalutamide for Patients with Metastatic Castration-Resistant Prostate Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?