Study on Enzalutamide and Talazoparib for Treating Metastatic Hormone-Naïve Prostate Cancer in Patients

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What is this study about?

This clinical trial is focused on studying the treatment of metastatic hormone-naïve prostate cancer, a type of prostate cancer that has spread to other parts of the body but has not yet been treated with hormone therapy. The study is evaluating the effectiveness of two medications, Enzalutamide and Talazoparib (also known by the code name PF-06944076), in combination with a standard treatment called androgen deprivation therapy (ADT). The purpose of the study is to assess how well these medications work together in reducing the levels of a protein called prostate-specific antigen (PSA), which is often higher in men with prostate cancer.

Participants in the study will be randomly assigned to receive either the combination of Enzalutamide and Talazoparib or a placebo, along with ADT. The study will monitor the participants over a period of time to see how their PSA levels respond to the treatment. The goal is to determine if the combination of these medications can lead to a complete response, meaning the PSA levels drop to very low levels, indicating a reduction in cancer activity.

The trial will also look at other outcomes, such as how long participants remain free from cancer progression and their overall survival. Additionally, the study will monitor any side effects experienced by participants to ensure the safety of the treatment. The trial is expected to continue until 2025, with participants being closely observed throughout the study period to gather comprehensive data on the effectiveness and safety of the treatment.

1 joining the study

Upon joining the study, the patient will begin by providing informed consent, confirming understanding and agreement to participate in the trial.

The patient will undergo initial assessments to confirm eligibility, including medical history review and physical examination.

2 treatment initiation

The patient will start treatment with enzalutamide and talazoparib. Enzalutamide is administered as 40 mg film-coated tablets taken orally.

Talazoparib is provided in two forms: 0.1 mg and 0.25 mg hard capsules, also taken orally. The specific dosage and frequency will be determined by the study protocol.

3 treatment duration

The treatment will continue for a specified period, with regular monitoring to assess the patient’s response and any side effects.

The primary goal is to evaluate the antitumor activity of the combination treatment in patients with metastatic hormone-naïve prostate cancer.

4 monitoring and assessments

Throughout the trial, the patient will attend scheduled visits for laboratory tests and imaging studies to monitor the cancer’s response to treatment.

The patient’s prostate-specific antigen (PSA) levels will be measured regularly to assess treatment effectiveness.

5 completion of treatment

At the end of the treatment period, the patient will undergo final assessments to evaluate the overall response to the therapy.

The study aims to determine the percentage of patients achieving a complete response, defined as PSA levels below 0.2 ng/mL at month 12.

6 follow-up

After completing the treatment, the patient will continue to be monitored for any long-term effects and overall survival.

Follow-up visits will be scheduled to ensure the patient’s well-being and to gather additional data for the study.

Who Can Join the Study?

Must be an adult over 18 years old and have signed a form agreeing to participate in the study.
Must agree to use a condom during sexual activity with a pregnant woman and use additional effective birth control methods during the study and for a certain period after the last dose of medication.
Must agree not to donate sperm during the study and for a certain period after the last dose of medication.
Must have a prostate-specific antigen (PSA) level of 4 ng/mL or higher at diagnosis or before starting hormone therapy.
Must be willing and able to attend scheduled visits, follow the treatment plan, and undergo tests and procedures required by the study.
Must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1, which means being fully active or having some symptoms but still able to carry out light work.
Must have high-volume metastatic disease, which means cancer has spread to other parts of the body, as shown by scans.
Must have a life expectancy of at least 12 months.
Must have a confirmed diagnosis of prostate adenocarcinoma, a type of prostate cancer, without certain other features, based on recent biopsy results.
Must be willing and able to provide tumor samples during the study for additional research.
Must have adequate blood and organ function, as shown by specific medical tests, within 28 days before starting the study treatment.
If taking bisphosphonates or denosumab, medications for bone health, the dosage must have been stable for at least 4 weeks before starting the study.

Who Cannot Join the Study?

Patients who have already received treatment for their prostate cancer.
Patients with other types of cancer that are not under control.
Patients with serious heart problems.
Patients with severe liver or kidney disease.
Patients who are unable to take oral medications.
Patients with any condition that might make it unsafe for them to participate in the study.
Patients who are allergic to any of the study medications.
Patients who are participating in another clinical trial.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Hospital Universitario 12 De Octubre	Madrid	Spain
Hospital Del Mar	Barcelona	Spain
Fundacion Instituto Valenciano De Oncologia	Valencia	Spain
Hospital Unviersitario Miguel Servet	Zaragoza	Spain
Hospital Clinic De Barcelona	Barcelona	Spain
Hospital Universitario Virgen De La Victoria	Malaga	Spain
Ilshdmjk Czyhwu Dtettkkcsbgmxxgig	L'hospitalet De Llobregat	Spain
Hhjgdcub Vdam dsgtebwa	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Spain	Not recruiting	02.09.2020

Trial locations

Investigated drugs:

Enzalutamide

Enzalutamide is a medication used to treat prostate cancer. It works by blocking the effects of male hormones that can promote the growth of cancer cells. In this trial, enzalutamide is being tested for its ability to help control prostate cancer when used in combination with other treatments.

Talazoparib (PF-06944076) is an experimental drug being studied for its potential to treat prostate cancer. It is believed to work by interfering with the cancer cells’ ability to repair their DNA, which may lead to the death of these cells. In this trial, talazoparib is being used alongside enzalutamide to see if the combination is more effective in treating prostate cancer.

ADT (Androgen Deprivation Therapy) is a standard treatment for prostate cancer that reduces the levels of male hormones in the body. These hormones can fuel the growth of prostate cancer cells, so lowering their levels can help slow the progression of the disease. In this trial, ADT is used in combination with enzalutamide and talazoparib to evaluate its effectiveness in treating metastatic hormone-naïve prostate cancer.

Investigated diseases:

Prostate cancer

Metastatic Hormone-Naïve Prostate Cancer (mHNPC) – This is a type of prostate cancer that has spread to other parts of the body but has not yet been treated with hormone therapy. The disease begins in the prostate gland and can progress to affect bones, lymph nodes, and other organs. In its early stages, it may not cause noticeable symptoms, but as it advances, it can lead to urinary difficulties, bone pain, and other systemic symptoms. The progression of mHNPC is influenced by the cancer’s ability to grow in the presence of normal levels of male hormones. Over time, the cancer may become resistant to hormone therapy, leading to more aggressive disease behavior. The focus of research is often on understanding how the cancer spreads and finding ways to slow its progression.

Trial ID:

2023-509387-24-00

Protocol code:

MEDOPP234

NCT ID:

NCT04332744

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Enzalutamide and Talazoparib for Treating Metastatic Hormone-Naïve Prostate Cancer in Patients

What is this study about?

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