Study of Fuzuloparib, Abiraterone Acetate, and Prednisone for First-Line Treatment in Patients with Metastatic Castration-Resistant Prostate Cancer

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What is this study about?

This clinical trial is focused on studying a type of prostate cancer known as Metastatic Castration-Resistant Prostate Cancer (mCRPC). This is a form of prostate cancer that has spread to other parts of the body and continues to grow even when the amount of testosterone in the body is reduced to very low levels. The study is investigating the effectiveness of a new treatment combination that includes the drug Fuzuloparib, along with Abiraterone Acetate and Prednisone (referred to as AA-P). Fuzuloparib is being tested to see if it can improve outcomes when added to the standard treatment of AA-P.

The purpose of the study is to determine if the combination of Fuzuloparib with AA-P is more effective than a placebo combined with AA-P as a first-line treatment for patients with mCRPC. Participants in the study will be randomly assigned to receive either the Fuzuloparib combination or the placebo combination. The study is designed to be “double-blind,” meaning neither the participants nor the researchers will know who is receiving the actual treatment or the placebo, to ensure unbiased results.

Throughout the study, participants will take the medications orally, as they are in the form of tablets or capsules. The study will monitor the progression of the cancer and assess the overall health and survival of the participants. The trial aims to provide valuable information on whether adding Fuzuloparib to the existing treatment can offer better outcomes for patients with this challenging form of prostate cancer.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age, organ function, and disease progression.

Blood and tumor tissue samples may be collected to determine specific genetic markers.

2 randomization

Participants are randomly assigned to one of two groups: one receiving the study medication fuzuloparib combined with abiraterone acetate and prednisone, and the other receiving a placebo combined with the same medications.

This process is double-blind, meaning neither the participant nor the study team knows which group the participant is in.

3 medication administration

Participants take abiraterone acetate as a 500 mg film-coated tablet orally once daily.

Participants take prednisone as a 5 mg tablet orally twice daily.

Participants in the study medication group take fuzuloparib orally, while those in the placebo group take a placebo capsule.

4 ongoing monitoring

Regular monitoring is conducted to assess the effectiveness and safety of the treatment. This includes imaging tests and blood tests.

Participants are evaluated for disease progression and any side effects from the medications.

5 end of treatment

The study treatment continues until disease progression, unacceptable side effects, or the participant decides to withdraw.

After the treatment ends, follow-up assessments are conducted to monitor the participant’s health and gather additional data.

Who Can Join the Study?

  • Must be at least 18 years old.
  • Organs must be working well, and no blood transfusion or special blood treatments should have been done within 2 weeks before the blood test.
  • If you can ejaculate and are sexually active, you must agree to use effective birth control and not donate sperm from the first dose until 3 months after the last dose of the study treatment.
  • Must join the clinical trial voluntarily, understand it, and have signed the informed consent form.
  • Must have an ECOG performance status score of 0 to 1, which means you are fully active or have some symptoms but can still do light work.
  • Expected to live for at least 6 more months.
  • Must have prostate adenocarcinoma, a type of prostate cancer, confirmed by tests, with no signs of other specific cancer types.
  • Must have cancer that has spread to other parts of the body, shown by imaging tests.
  • The prostate cancer must have gotten worse while on treatment to lower male hormones.
  • Must be on continuous treatment with a drug that lowers male hormones or have had surgery to remove both testicles. If you haven’t had the surgery, you must plan to keep taking the hormone-lowering drug before and during the study.
  • Testosterone levels must be at or below the castration level, which is 50 ng/dL or 1.73 nmol/L, during screening.
  • Must provide blood and tumor tissue samples during screening to check for DRD status. If you are in Cohort 2, you must be DRD positive, meaning you have a specific genetic feature related to DNA repair.

Who Cannot Join the Study?

  • Patients who do not have metastatic castration-resistant prostate cancer cannot participate. This is a type of prostate cancer that has spread to other parts of the body and does not respond to treatments that lower testosterone.
  • Only male patients are eligible for this study.
  • Patients who are part of a vulnerable population are not eligible. This means groups of people who might need special protection, like those who cannot make decisions for themselves.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Szpital Wojewodzki Im. Mikolaja Kopernika W Koszalinie Koszalin Poland

Other Sites

Site Name City Country Status
Universitair Ziekenhuis Gent Gent Belgium
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Hospital Universitario 12 De Octubre Madrid Spain
Hospital Del Mar Barcelona Spain
Fundacion Instituto Valenciano De Oncologia Valencia Spain
Algemeen Ziekenhuis Groeninge Kortrijk Belgium
Bekes Varmegyei Koezponti Korhaz Gyula Hungary
Komarom-Esztergom Varmegyei Szent Borbala Korhaz Tatabanya Hungary
Clinical Research Center Sp. z o.o. Medic-R sp.k. Poznan Poland
Virgen del Rocío University Hospital Sevilla Spain
Hospital Clinic De Barcelona Barcelona Spain
Semmelweis University Budapest Hungary
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie Cracow Poland
Nemocnice AGEL Novy Jicin a.s. Novy Jicin Czechia
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Fakultni Thomayerova nemocnice Prague Czechia
Centre De Lutte Contre Le Cancer Eugene Marquis Rennes France
Hospital Universitario Virgen De La Victoria Malaga Spain
Cqwxbt Llop Bkxoza Lyon France
Stlpmdsj Pyxmwlkpd Szx z oxma Gdynia Poland
Relzlsmqfu Sujjyss Sxezefkoszdabiz Ioj Dhk Wghmtimuvx Bnfgyksgivno Grudziadz Poland
Pwxo Twntf Hfyuwcnq Uiboofjycnbs Sabadell Spain
Bdyonhpqqao Vdvaaievd Ohfinzdxyjsu Kecskemet Hungary
Cbpcio de Rkgyqkjgoesew &eitgtw Cbwzkcak Sybtpz Adnd STRASBOURG, Alsace France
Ntgnkrij Ijrhsixa Oglgzyllc Iaz Myazr Snicdwnqrxyunlqvtitexcpsorqn Iapkfnba Bojtplxn Cracow Poland
Iwgeugvk Czvsgb Dpbarnyzdyhzetofm L'hospitalet De Llobregat 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
14.12.2021
Czechia Czechia
Not recruiting
14.12.2021
France France
Not recruiting
14.12.2021
Hungary Hungary
Not recruiting
14.12.2021
Poland Poland
Not recruiting
14.12.2021
Spain Spain
Not recruiting
14.12.2021

Trial locations

Fuzuloparib is a medication being studied for its potential to treat metastatic castration-resistant prostate cancer. It is being tested to see if it can help slow down the progression of the disease when used in combination with other treatments.

Abiraterone Acetate is a medication used to treat prostate cancer. It works by decreasing the production of certain hormones in the body that can promote the growth of cancer cells.

Prednisone is a type of steroid that is often used in combination with other cancer treatments. It helps reduce inflammation and can improve the effectiveness of other medications used to treat cancer.

Metastatic Castration-Resistant Prostate Cancer – This is a type of prostate cancer that continues to grow and spread to other parts of the body despite treatments that lower testosterone levels. It is characterized by cancer cells that have adapted to survive in a low-testosterone environment. The disease often progresses with the cancer spreading to bones, lymph nodes, or other organs. Patients may experience symptoms such as bone pain, urinary issues, or fatigue as the cancer advances. The progression of the disease can vary, with some individuals experiencing rapid changes while others may have a slower progression.

Trial ID:
2023-509396-16-00
Protocol code:
SHR3162-III-305
NCT ID:
NCT04691804
Trial Phase:
Therapeutic confirmatory (Phase III)

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