Study on the Effectiveness of Abiraterone, Capivasertib, and Enzalutamide in Patients with Metastatic Prostate Cancer

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What is this study about?

This clinical trial is focused on studying treatments for metastatic prostate cancer, which is a type of cancer that has spread beyond the prostate gland. The study aims to evaluate the effectiveness of different treatment options based on specific genetic markers found in the cancer cells. These markers are identified through a process involving circulating tumor DNA (ctDNA) or tumor tissue DNA. The goal is to determine which treatment works best for patients with these specific markers, compared to the standard treatments currently available.

The trial involves several medications, including abiraterone, capivasertib, enzalutamide (also known as MDV3100), niraparib, darolutamide (also known as ODM-201 or BAY 1841788), cabazitaxel, olaparib, docetaxel, and radium ra 223 dichloride. These medications are used in different combinations to see how well they work in slowing down the progression of the cancer. Some of these drugs are taken orally as tablets, while others are given through intravenous infusion, which means they are delivered directly into the bloodstream through a vein.

Participants in the study will receive one of these treatments or a placebo, and their progress will be monitored over time to see how the cancer responds. The study will help researchers understand which treatments are most effective for patients with specific genetic markers, potentially leading to more personalized and effective treatment options for those with metastatic prostate cancer.

1 joining the study

Upon joining the study, the patient will be informed about the trial’s objectives and procedures. The patient must provide informed consent, indicating understanding and agreement to participate in the study.

2 initial assessment

The patient will undergo an initial assessment to confirm eligibility. This includes a review of medical history, physical examination, and necessary imaging tests such as CT or MRI scans to document metastatic disease.

3 treatment assignment

The patient will be randomly assigned to a treatment group based on biomarker analysis. This analysis uses DNA from tumor tissue or blood to determine the most suitable treatment class.

4 treatment administration

The patient will receive one of the following treatments, depending on the assigned group:

Abiraterone: Oral administration, dosage as prescribed by the study protocol.

Capivasertib: Oral administration, dosage as prescribed by the study protocol.

Enzalutamide: Oral administration, dosage as prescribed by the study protocol.

Niraparib and Abiraterone Acetate: Oral administration, dosage as prescribed by the study protocol.

Cabazitaxel: Administered via intravenous infusion, dosage as prescribed by the study protocol.

Olaparib: Oral administration, dosage as prescribed by the study protocol.

Darolutamide: Oral administration, dosage as prescribed by the study protocol.

Radium Ra 223 Dichloride: Administered via intravenous route, dosage as prescribed by the study protocol.

5 monitoring and follow-up

The patient will be monitored regularly to assess treatment effectiveness and side effects. This includes blood tests, imaging studies, and questionnaires about quality of life.

Progression-free survival will be evaluated to determine the time until disease progression or lack of clinical benefit.

6 completion of the study

The study is estimated to end by December 31, 2026. Upon completion, the patient will undergo a final assessment to evaluate overall health and treatment outcomes.

Who Can Join the Study?

Male patients, aged over 18 years, with confirmed prostate cancer.
Starting treatment for cancer that has spread to other parts of the body.
Includes patients with newly diagnosed cancer that still responds to hormones or cancer that has progressed despite low testosterone levels.
Cancer spread must be confirmed by imaging tests like bone scans, CT, or MRI.
Must be in good health to receive all treatments in the study, with adequate blood, liver, and kidney function.
Albumin level in the blood must be 28 g/L or higher.
Performance status, which measures daily living abilities, should be between 0 and 2 on the ECOG/WHO scale.
Must be able to understand the study information and sign a consent form.
Must agree to use effective birth control during the study and for 6 months after, and not donate sperm during this time.

Who Cannot Join the Study?

Patients who do not have prostate cancer cannot participate.
Patients who are not male cannot participate.
Patients who are not within the specified age range cannot participate. The age range is typically defined by the study, so it’s important to check if you fall within it.
Patients who are part of a vulnerable population, which means groups that might need special protection, cannot participate.

Where you can join this trial?

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Other Sites

Site Name	City	Country
Universitetssykehuset Nord-Norge HF	Tromsø	Norway
Region Oerebro Laen	Orebro	Sweden
Centre hospitalier universitaire de Liege	Liege	Belgium
Universitair Ziekenhuis Gent	Gent	Belgium
Helse Stavanger HF	Stavanger	Norway
Az Maria Middelares Gent	Gent	Belgium
Algemeen Ziekenhuis Groeninge	Kortrijk	Belgium
Vitaz	Sint-Niklaas	Belgium
Algemeen Ziekenhuis Damiaan Oostende	Ostend	Belgium
Region Dalarna	Falun	Sweden
Laenssjukhuset I Kalmar Region Kalmar Laen	Kalmar	Sweden
Region Vaesternorrland	Sundsvall	Sweden
Soedra Aelvsborg Hospital Vaestra Goetalandsregionen	Boras	Sweden
Sørlandet sykehus Kristiansand	Kristiansand	Norway
Karolinska University Hospital	Solna	Sweden
Az St-Jan Brugge-Oostende A.V.	Brugge	Belgium
Norrlands University Hospital	Umea	Sweden
Gasthuiszusters Antwerpen	Antwerp	Belgium
Sykehuset Oestfold HF Kalnes	Graalum	Norway
Sankt Gorans Sjukhus	Stockholm	Sweden
Region Joenkoepings Laen	Jönköping	Sweden
Ziekenhuis Oost Limburg	Genk	Belgium
Region Kronoberg	Vaxjo	Sweden
CHU Helora	La Louviere	Belgium
Ohzaeplvuclkxjheevjxdljpgy	Aalst	Belgium
Aduubngp Uayjcqxyqw Hehgnsse	Lorenskog	Norway
Uuqcbra Udrgpbfvrk Hitsdlnf	Uppsala	Sweden
Hvxqm Mrfgv Oa Rcoxxcm Hp	Aalesund	Norway
Rpgmim Vexldbkhb	Karlstad	Sweden

Trial status

Country	Status	Recruitment Start
Belgium	Recruiting	15.01.2019
Norway	Recruiting	15.01.2019
Sweden	Recruiting	15.01.2019

Trial locations

Investigated drugs:

Abiraterone is a medication used to treat prostate cancer by lowering the levels of male hormones in the body, which can help slow the growth of cancer cells.

Enzalutamide is a treatment for prostate cancer that works by blocking the effects of male hormones, which can help prevent cancer cells from growing and spreading.

Docetaxel is a chemotherapy drug used to treat prostate cancer by interfering with the growth and division of cancer cells, ultimately leading to their death.

Cabazitaxel is another chemotherapy medication used for prostate cancer, particularly when other treatments have not been effective. It works by stopping cancer cells from dividing and growing.

Olaparib is a targeted therapy used in prostate cancer treatment that works by interfering with the cancer cells’ ability to repair their DNA, leading to cell death.

Radium-223 is a radiopharmaceutical used to treat prostate cancer that has spread to the bones. It works by delivering targeted radiation to the cancer cells in the bones, helping to relieve pain and slow the progression of the disease.

Investigated diseases:

Prostate cancer metastatic

Prostate Cancer – Prostate cancer is a disease where cells in the prostate gland grow uncontrollably. It often progresses slowly and may not show symptoms in the early stages. As it advances, it can lead to difficulties in urination, blood in urine, or pelvic discomfort. The disease can spread to nearby tissues or distant parts of the body, such as bones and lymph nodes. There are different stages, including metastatic hormone-sensitive and castration-resistant prostate cancer, which indicate how far the cancer has spread and how it responds to hormone therapy. Understanding the progression of prostate cancer is crucial for determining the most effective treatment strategies.

Trial ID:

2023-506857-40-00

NCT ID:

NCT03903835

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effectiveness of Abiraterone, Capivasertib, and Enzalutamide in Patients with Metastatic Prostate Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?