Study of Niraparib, Abiraterone Acetate, and Prednisone for Patients with Gene-Mutated Metastatic Castration-Sensitive Prostate Cancer

3 1 1

What is this study about?

This clinical trial is focused on studying a type of prostate cancer known as metastatic castration-sensitive prostate cancer (mCSPC) that has specific genetic changes called homologous recombination repair (HRR) gene mutations. The study is testing a combination of medications to see if they can improve outcomes for patients with this type of cancer. The medications being tested include niraparib, abiraterone acetate, and prednisone. Niraparib is a medication that may help prevent cancer cells from repairing themselves, while abiraterone acetate and prednisone are used to manage prostate cancer by reducing the levels of male hormones that can promote cancer growth.

The purpose of the study is to determine if the combination of niraparib with abiraterone acetate and prednisone is more effective than using abiraterone acetate and prednisone alone. Participants in the study will be randomly assigned to receive either the combination of all three medications or just abiraterone acetate and prednisone. Some participants may receive a placebo instead of niraparib. The study will be conducted over a period of time, and participants will take the medications orally in the form of tablets or capsules. The study aims to observe the effects of these treatments on the progression of the cancer.

Throughout the study, participants will undergo regular monitoring, which may include imaging tests like computed tomography (CT) or magnetic resonance imaging (MRI) to track the cancer’s response to the treatment. The study will help researchers understand if the new combination of medications can provide better outcomes for patients with HRR gene-mutated mCSPC. The study is expected to continue until 2027, with the goal of improving treatment options for this specific type of prostate cancer.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying a diagnosis of prostate adenocarcinoma and the presence of specific gene mutations related to homologous recombination repair (HRR).

Imaging tests such as CT, MRI, or a bone scan may be performed to document metastatic disease.

2 treatment initiation

Participants begin treatment with abiraterone acetate and prednisone. Abiraterone acetate is administered orally in tablet form at a dosage of 250 mg.

Prednisone is also taken orally in tablet form at a dosage of 5 mg.

3 combination therapy

Participants are randomly assigned to receive either a combination of niraparib with abiraterone acetate and prednisone or a placebo with abiraterone acetate and prednisone.

Niraparib is administered orally in capsule form at a dosage of 100 mg.

4 ongoing treatment

The treatment continues with regular monitoring to assess the effectiveness and safety of the medication. This includes periodic imaging tests to evaluate disease progression.

Participants are required to continue androgen deprivation therapy (ADT) throughout the treatment phase.

5 end of study

The study is estimated to conclude by May 7, 2027. At the end of the study, final assessments are conducted to determine the overall effectiveness of the treatment in improving radiographic progression-free survival (rPFS).

Who Can Join the Study?

  • Must have a confirmed diagnosis of prostate adenocarcinoma, which is a type of prostate cancer.
  • Must have a specific change in genes related to homologous recombination repair (HRR). This means there is a change in the genes that help fix DNA damage.
  • Must have cancer that has spread to other parts of the body, as shown by imaging tests like a CT scan (a detailed X-ray) or an MRI (a scan that uses magnets and radio waves). If the cancer has spread to the bones, it must be confirmed by a bone scan or other imaging tests. If the cancer is only in the lymph nodes, the patient cannot participate.
  • Must have started androgen deprivation therapy (ADT) at least 14 days before joining the study. ADT is a treatment that lowers male hormones to slow the growth of cancer. The patient must agree to continue this therapy during the study.
  • Only male participants are eligible for this study.

Who Cannot Join the Study?

  • Patients who do not have a mutation in the HRR gene. This gene is involved in repairing DNA, which is the genetic material in our cells.
  • Patients who do not have metastatic castration-sensitive prostate cancer (mCSPC). This is a type of prostate cancer that has spread to other parts of the body but still responds to treatments that lower testosterone.
  • Patients who are female, 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 Status
Centr Georges Francois Leclerc Dijon France
Technische Universitaet Dresden Dresden Germany
Hospital Jerez de la Frontera Jerez De La Frontera Spain

Other Sites

Site Name City Country Status
Istituto Oncologico Veneto Padua Italy
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy Bydgoszcz Poland
Azienda Socio Sanitaria Territoriale Di Cremona Cremona Italy
Istituto Europeo Di Oncologia S.r.l. Milan Italy
Hospital Foch Suresnes France
IRCCS Istituto Nazionale Tumori Fondazione Pascale Naples Italy
Azienda Provinciale Per I Servizi Sanitari Trento Italy
Casa Sollievo Della Sofferenza San Giovanni Rotondo Italy
Staedtisches Klinikum Braunschweig gGmbH Brunswick Germany
Næstved Hospital Næstved Denmark
Hospital Universitario 12 De Octubre Madrid Spain
Algemeen Ziekenhuis Delta Roeselare Belgium
Azienda Unita Locale Socio Sanitaria N 8 Berica Vicenza Italy
Studienpraxis Urologie Susan Feyerabend MD Tilman Todenhoefer MD PhD GbR Nuertingen Germany
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur Namur Belgium
Komarom-Esztergom Varmegyei Szent Borbala Korhaz Tatabanya Hungary
Institut Sainte Catherine Avignon France
Complex Oncological Center Plovdiv EOOD Plovdiv Bulgaria
Szpital Grochowski Im.Dr Med. Rafała Masztaka Sp. z o.o. Warsaw Poland
Specjalistyczne Gabinety Sp. z o.o. Cracow Poland
Azienda Sanitaria Locale Napoli 2 Nord Frattamaggiore Italy
Polimed Specjalistyczna Przychodnia Lekarska Wroclaw Poland
University Of Debrecen Debrecen Hungary
Ospedale San Raffaele S.r.l. Milan Italy
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS Candiolo Italy
Hospital Clinic De Barcelona Barcelona Spain
Fakultni Nemocnice Hradec Kralove Novy Hradec Kralove Czechia
Karolinska University Hospital Solna Sweden
Champalimaud Clinical Centre Lisbon Portugal
Sygehus Lillebaelt Vejle Sygehus Vejle Denmark
Aalborg University Hospital Aalborg Denmark
Gasthuiszusters Antwerpen Antwerp Belgium
Borsod-Abauj-Zemplen Varmegyei Koezponti Korhaz Es Egyetemi Oktatokorhaz Miskolc Hungary
Hospital General Universitario De Castellon Castello De La Plana Spain
In Vivo Sp. z o.o. Bydgoszcz Poland
CHC MontLegia Liege Belgium
Unite De Recherche Clinique HIA Begin Saint-Mande France
Rigshospitalet Copenhagen Denmark
Azienda USL Toscana Sud Est Arezzo Italy
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
University Of Szeged Szeged Hungary
Krajska nemocnice Liberec a.s. Liberec Czechia
Hospital Universitario Hm Monteprincipe Boadilla Del Monte Spain
Hospital Universitario Virgen De La Victoria Malaga Spain
Clinique Saint-Pierre Ottignies (CSPO) Ottignies Belgium
Azienda Ospedaliero Universitaria Pisana Pisa Italy
Soedersjukhuset AB Stockholm Sweden
Cnebdw Lwyx Bbqodi Lyon France
Hrimhjzv Uwhgtvamtieqi Dj Ls Ptwzqeuo Madrid Spain
Stxmyhfl Pltixbcrc Syj z oire Gdynia Poland
Penu Tvkrx Hvubgihb Ubznwffacfuc Sabadell Spain
Ccyccj di Rdwvdvukggsbq &virjcd Cjxmmaeo Soiklv Amqu STRASBOURG, Alsace France
Izigctsx Rjxztnkek Psq Lc Spsymi Djp Tlvzpq Darm Alvgdrx Ihwe Syvajw Meldola Italy
Bkvjtnlu Uixkfhqxoj Hvnucdsa Cwqamp Besançon France
Sqh Eedosqess Hmdmkmkb Tsmqeyn Tilburg The Netherlands
Hbjgvxvb Dw Li Sjdxe Cmpg I Sawq Pyw Barcelona Spain
Ikqkwsiy Cznetl Dzpvlkfuvmocbcswy L'hospitalet De Llobregat Spain
Czgbre Obxez Lyzbjvl Lille France
Hlckgvby Undapshcxiqtv dq A Cwysgf A Coruna Galicia Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
16.10.2020
Bulgaria Bulgaria
Not recruiting
16.10.2020
Czechia Czechia
Not recruiting
16.10.2020
Denmark Denmark
Not recruiting
16.10.2020
France France
Not recruiting
16.10.2020
Germany Germany
Not recruiting
16.10.2020
Hungary Hungary
Not recruiting
16.10.2020
Italy Italy
Not recruiting
16.10.2020
Poland Poland
Not recruiting
16.10.2020
Portugal Portugal
Not recruiting
16.10.2020
Spain Spain
Not recruiting
16.10.2020
Sweden Sweden
Not recruiting
16.10.2020
The Netherlands The Netherlands
Not recruiting
16.10.2020

Trial locations

Niraparib is a medication used in this trial to see if it can help treat prostate cancer that has specific genetic mutations. It is being tested to find out if it can improve the condition of patients when used together with other medications.

Abiraterone Acetate is a medication that helps lower the levels of certain hormones in the body. It is used in this trial to see if it can help control prostate cancer when combined with other treatments.

Prednisone is a type of steroid that is used to reduce inflammation and help manage symptoms. In this trial, it is used alongside other medications to see if it can improve the treatment of prostate cancer.

Investigated diseases:

Metastatic Castration-Sensitive Prostate Cancer (mCSPC) – This is a type of prostate cancer that has spread to other parts of the body but still responds to treatments that lower testosterone levels. It is characterized by the presence of cancer cells in distant organs or bones, beyond the prostate gland. The disease progresses as cancer cells continue to grow and spread, despite initial responses to hormone therapy. Over time, the cancer may become resistant to treatments that lower testosterone, leading to further progression. The presence of mutations in homologous recombination repair (HRR) genes can influence the behavior and progression of the disease.

Trial ID:
2023-506365-64-00
Protocol code:
67652000PCR3002
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

  • Study of ifinatamab deruxtecan alone or in combination with other treatments for patients with metastatic castration-resistant prostate cancer

    Recruiting

    1 1 1 1
    Investigated diseases:
    France Germany Ireland Italy The Netherlands Poland +1
  • A study to evaluate the safety and effectiveness of AZD9750 and saruparib in patients with metastatic prostate cancer

    Recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands Spain