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

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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 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.
Step 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.
Step 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.
Step 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 trial?

16 criteria

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 trial?

12 criteria

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

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Verified sites

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Verified
Centre Hospitalier Regional Et Universitaire De Brest
Brest, France
Verified
Centre Oscar Lambret
Lille, France
Responsive
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Madrid, Spain

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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.

What is already known about the treatment

Talazoparib
An oral PARP inhibitor medication that works by blocking DNA repair in cancer cells, making them more vulnerable to destruction. This targeted therapy is primarily used in the treatment of metastatic prostate cancer, particularly in cases where the cancer has become resistant to standard hormone therapy. The drug works at the molecular level by trapping PARP enzymes on damaged DNA, preventing cancer cells from repairing themselves and ultimately leading to their death.
Enzalutamide
An oral hormone therapy medication that belongs to the class of androgen receptor inhibitors, used in the treatment of metastatic prostate cancer. It works by blocking the effects of testosterone and other male hormones that can stimulate cancer growth, effectively preventing these hormones from binding to androgen receptors in prostate cancer cells. The medication is particularly valuable in treating castration-resistant prostate cancer, where the disease continues to progress despite traditional hormone therapy.
Abiraterone
An oral medication that works by blocking the production of androgens (male hormones) throughout the body, including in the prostate, adrenal glands, and tumor tissue. It belongs to the class of CYP17 inhibitors and is used in the treatment of metastatic prostate cancer, particularly when the disease has become resistant to other forms of hormone therapy. The drug works by inhibiting an enzyme crucial for androgen production, thereby helping to slow or stop the growth of prostate cancer cells.

Investigated diseases

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.