Study of Talazoparib and Enzalutamide combination treatment for patients with metastatic prostate cancer who previously received Abiraterone

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What is this study about?

This clinical trial focuses on patients with metastatic castration-resistant prostate cancer who have previously been treated with abiraterone. The study investigates a combination treatment using two medications: talazoparib and enzalutamide. This type of prostate cancer is characterized by the spread of cancer cells to other parts of the body and does not respond to treatments that lower testosterone levels.

The purpose of this study is to determine how effective the combination of talazoparib plus enzalutamide is as a first-line treatment for patients whose disease has progressed after using abiraterone. Both study medications are taken orally in the form of capsules. Talazoparib is available in two strengths (0.1 mg and 0.25 mg), while enzalutamide is given at a specific dose.

During the study, participants will receive both medications and will be monitored regularly through various tests. The study will track how well the treatment works by measuring changes in PSA (a protein that may indicate prostate cancer activity) levels and by using imaging techniques such as computed tomography and magnetic resonance imaging to assess the response to treatment. Participants will also provide blood samples and tumor tissue samples for additional analysis.

1 Initial treatment phase

You will receive two medications: enzalutamide and talazoparib. Both medications are taken orally in the form of hard capsules.

During treatment, you must continue your current hormone therapy (androgen deprivation therapy) if you have not had surgical removal of testicles.

Regular blood tests will be conducted to monitor your organ function, including liver function, kidney function, and blood cell counts.

2 12-16 week evaluation

Your PSA levels (prostate-specific antigen) will be measured to assess response to treatment.

Imaging tests will be performed to evaluate any changes in tumor size.

The medical team will assess if the treatment is working by looking for at least a 50% decrease in PSA levels or improvement in imaging results.

3 Ongoing monitoring

Regular assessments will continue to track the progression of your disease.

Imaging scans will be performed to monitor any changes in bone or soft tissue.

Blood samples will be collected for biomarker analysis.

Side effects will be monitored and recorded according to standardized criteria.

4 Safety requirements

You must use appropriate birth control methods during the study and for 3 months after the final treatment.

You cannot participate in other clinical trials while receiving this treatment.

You must provide tumor tissue samples for analysis during the study.

Regular attendance at scheduled visits and compliance with all study procedures is required.

Who Can Join the Study?

Must be a male aged 18 or older
Must have a life expectancy of at least 6 months
Must be on ongoing hormone therapy (androgen deprivation therapy) unless previously had surgical removal of testicles
Must have evidence that prostate cancer has gotten worse after at least 12 weeks of treatment with abiraterone, shown by:
– Rising PSA levels (a blood test marker)
– Limited spread of cancer on scans
If previously treated with docetaxel (a chemotherapy drug):
– Must have received no more than 6 treatments
– Last treatment must be at least 6 months before study start
Must have adequate organ function, including:
– Acceptable blood counts
– Good kidney function
– Good liver function
Must be able to swallow tablets
Must agree to use effective birth control methods during the study and for 3 months after
Must not donate sperm during the study and for 3 months after
Must not participate in other clinical trials while in this study
Must have confirmed prostate cancer diagnosis
Must be able to provide written consent
Must have good physical function (ECOG status 0 or 1, meaning able to perform daily activities)
Must be willing to provide:
– Tumor samples
– Blood samples
– Consent for genetic testing
Must have evidence of cancer spread on medical scans
Must have no symptoms or only mild symptoms from prostate cancer

Who Cannot Join the Study?

Prior use of enzalutamide (a hormone therapy medication) or any other similar medications for prostate cancer treatment
Active or untreated brain metastases (cancer that has spread to the brain). Patients with treated and stable brain metastases may be eligible
Significant heart conditions, including uncontrolled high blood pressure, heart failure, or recent heart attack (within 6 months)
Severe liver problems or abnormal liver function tests
Other active cancers requiring treatment (except for non-melanoma skin cancer or treated early-stage cancer)
Known allergic reactions to talazoparib or enzalutamide
Participation in other clinical trials within 30 days before starting this study
Serious infections requiring treatment, including active HIV, Hepatitis B, or Hepatitis C
Major surgery within 4 weeks before starting the study
Any medical condition that could interfere with the study medication or put the patient at increased risk
Female patients (study is specifically 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
Centre Hospitalier Regional Et Universitaire De Brest	Brest	France

Other Sites

Site Name	City	Country
Hospital Universitario 12 De Octubre	Madrid	Spain
Hospital Del Mar	Barcelona	Spain
Hospital Clinic De Barcelona	Barcelona	Spain
Hospital Universitario De Cruces	Barakaldo	Spain
Hospital Universitari De Girona Doctor Josep Trueta	Girona	Spain
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Hospital Universitario Virgen De La Victoria	Malaga	Spain
Hmhphwbo Uxylpiexgqnjp Mhgokny Dd Vjwrnfrdbn	Santander	Spain
Pypb Tvxox Hueqmnjv Upkzbksmvvww	Sabadell	Spain
Gpqjio Hdypgqpftrw Ugzwgtqivermc Pcxpv Pilhgfwkwpc Ew Nkoxugibauxn	Paris	France
Feanksaap Pfsr Lh Iarwvwsotupie Beesxgzny Dwc Hzylwerk Umiwmjujjejqz Ld Prm	Madrid	Spain
Curqpo Ovrkp Lnupkab	Lille	France
Hikkggef Uppmgqclfboizn Sjxhjlwfar &oihnpv Hyvplbs df Hqbwmslxsii	STRASBOURG, Alsace	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	01.05.2024
Spain	Recruiting	01.05.2024

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.

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.

Abiraterone is also a hormone therapy medication used in treating prostate cancer. It works by stopping the production of testosterone throughout the body, including in other tissues besides the testicles. This medication is mentioned as part of the patients’ previous treatment before entering the trial.

Prostate Cancer – A disease that develops in the prostate gland, which is part of the male reproductive system. The cancer begins when prostate cells start to grow uncontrollably, typically developing very slowly over time. As the disease advances, cancer cells can spread from the prostate to other parts of the body, particularly the bones and lymph nodes. Initially, prostate cancer may not cause any symptoms, but in later stages, it can cause difficulty with urination, blood in the urine, or pain in the pelvic area. In some cases, the cancer can become resistant to standard hormone treatments, which is known as castration-resistant prostate cancer.

Trial ID:

2023-510536-37-00

Protocol code:

TEAM PC

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Talazoparib and Enzalutamide combination treatment for patients with metastatic prostate cancer who previously received Abiraterone

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?