Trial for advanced prostate cancer: combining new drug Fuzuloparib with standard therapy

Recruting new patients

Select region:

Navigation:

    What is this study about?

    This trial is a large, carefully planned test that aims to measure how well a new treatment for prostate cancer works. The treatment uses a medicine called Fuzuloparib, paired with other known medications, Abiraterone Acetate and Prednisone (together callled AA-P). It will be compared against a placebo—a substance that looks identical but doesn’t include the active drug—combined with AA-P. The particular type of cancer this trial is working on is a very challenging one that has spread in the body and resisted traditional hormonal treatments. The study will carefully check how well the cancer responds to the treatment and how the patients feel during the treatment, looking for signs of improvement or any side effects.

    Learn more about this Trial

      I accept the Terms of Use and Privacy Policy*

       I consent to the Service Operator sending commercial information*

      I consent to the Service Operator using telecommunications terminal devices and automatic calling systems in marketing communications*

      Success

      Your form submitted successfully!

      Error

      Sorry! your form was not submitted properly, Please check the errors above.

      Locations

      Where does the clinical trial take place?

      Gent , Belgium

      Haine Saint Paul , Belgium

      Kortrijk , Belgium

      Novy Jicin , Czechia

      Prague , Czechia

      La Roche-sur-Yon , France

      Lille , France

      Lyon , France

      Nimes , France

      Paris , France

      Pierre-Benite , France

      Rennes , France

      Saint-Herblain , France

      Strasbourg , France

      Toulouse , France

      Budapest , Hungary

      Budapest , Hungary

      Gyula , Hungary

      Kecskemu00e9t , Hungary

      Tatabanya , Hungary

      Gdynia , Poland

      Grudziadz , Poland

      Kobylniki , Poland

      Koszalin , Poland

      Krakow , Poland

      Poznan , Poland

      Warszawa , Poland

      Wroclaw , Poland

      Castellu00f3 de la Plana , Spain

      Barcelona , Spain

      Barcelona , Spain

      Barcelona , Spain

      Cu00f3rdoba , Spain

      Girona , Spain

      Madrid , Spain

      Madrid , Spain

      Madrid , Spain

      Mu00e1laga , Spain

      Sevilla , Spain

      Valencia , Spain

      London , United Kingdom

      London , United Kingdom

      London , United Kingdom

      Oxford , United Kingdom

      Sutton , United Kingdom

      You can join this study in:

      Study Steps

      How Complex Will My Study Be and What Phases Will I Go Through?

      In this clinical trial, patients are allocated to one of two treatment groups:

      1. Treatment group A (EXPERIMENTAL): Patients in this group will take Fuzuloparib in combination with Abiraterone Acetate and Prednisone (AA-P). The specific steps for the medications involved are as follows:
      – Fuzuloparib capsules (50 mg strength) at a dosage of 150 mg taken twice a day (Bid) by mouth (po).
      – Abiraterone acetate tablets (250 mg strength) at a dosage of 1000 mg taken once a day (Qd) by mouth.
      – Prednisone tablets (5 mg strength) at a dosage of 5 mg taken twice a day by mouth.

      2. Treatment group B (PLACEBO_COMPARATOR): Patients in this group will take a placebo equivalent of Fuzuloparib along with Abiraterone Acetate and Prednisone. The administration of the placebo and the other drugs will mirror the dosing of group A【9†source】.

      These are the medication steps for patients participating in the clinical trial based on the group they are assigned to. The exact period for taking these drugs will be in line with the study protocol and under the supervision of the trial’s medical staff.


      Diseases Under Investigation

      What Conditions Qualify Me for This Study?

      To join the study, you need to have a confirmed diagnosis of prostate adenocarcinoma and disease progression of metastatic prostate cancer while on androgen deprivation therapy【7†source】.


      Terms and conditions

      What Requirements I Have to Meet To Join This Study?

      When Am I Eligible to Join the Study?

      To join the study, you must meet the following Inclusion Criteria:

      • Informed consent: You must be able and willing to provide written informed consent.
      • ECOG performance status: You need to have a score of 0 to 1 on the ECOG performance status scale, which measures how your disease affects your daily living abilities. A score of 0 means you are fully active and can carry on all pre-disease activities without restriction; a score of 1 indicates you are restricted in physically strenuous activity but can walk and carry out light work.
      • Age requirement: You must be 18 years old or older.
      • Diagnosis confirmation: Your diagnosis of prostate adenocarcinoma must be confirmed.
      • Disease progression: You must have evidence of disease progression of metastatic prostate cancer while on androgen deprivation therapy.
      • Organ function: The functional level of your organs must meet the specified requirements (these should be detailed elsewhere in the trial documentation).
      • Biomarker assessment: You must provide blood and tumor tissue samples during the screening phase to determine the DRD (DNA damage repair deficiencies) status【9†source】.

      What Reasons Could Exclude Me from the Study?

      Exclusion Criteria:
      1. Prior treatment with any PARP inhibitor: PARP inhibitors are a group of pharmacological inhibitors that prevent poly (ADP-ribose) polymerase (PARP) from repairing DNA damage in cancer cells, leading them to die.
      2. Have received any systemic anti-tumor treatment during the mCRPC (metastatic Castration-Resistant Prostate Cancer) stage or non-metastatic CRPC stage.
      3. Have used any CYP3A4 inducers or inhibitors within 14 days prior to the first dose. CYP3A4 is an important enzyme in the body, mainly found in the liver and the intestine. It oxidizes small foreign organic molecules (xenobiotics), such as toxins or drugs, so that they can be removed from the body.
      4. Plan to receive any other anti-tumor treatment.
      5. Presence of radiologically confirmed tumor lesions in the brain.
      6. Contraindications to the use of Prednisone: Prednisone is a synthetic corticosteroid drug that is particularly effective as an immunosuppressant, and affects virtually all of the immune system.
      7. History of uncontrolled pituitary or adrenal dysfunction: The pituitary and adrenal glands are parts of the endocrine system that regulate several crucial bodily functions. Dysfunction could lead to significant hormonal imbalances and health issues.
      8. Uncontrolled hypertension: Blood pressure that is consistently too high and not managed adequately.
      9. Presence of active heart diseases.
      10. Human immunodeficiency virus-positive: HIV is a virus that attacks cells that help the body fight infection, making a person more vulnerable to other infections and diseases.
      11. Presence of dysphagia, chronic diarrhea, intestinal obstruction, or other factors affecting drug intake and absorption:
      – Dysphagia: Difficulty or discomfort in swallowing.
      – Intestinal obstruction: A blockage that keeps food or liquid from passing through your small intestine or large intestine (colon).
      12. Active HBV or HCV infection: HBV refers to Hepatitis B virus and HCV refers to Hepatitis C virus, both of which can cause infection and liver damage.
      13. Presence of concomitant diseases【9†source】.


      Investigational Medicinal Product

      What Products Are Being Used in This Study?

      The clinical trial involves the following drugs:

      • Fuzuloparib: A drug used in the experimental group which is a small molecule inhibitor targeting poly(ADP-ribose) polymerase (PARP), an enzyme involved in DNA repair. By inhibiting PARP, fuzuloparib can lead to the accumulation of DNA damage in cancer cells, particularly in those with existing DNA repair deficiencies, which may cause cell death and inhibit tumor growth.
      • Abiraterone acetate: This medication is used in combination with prednisone to treat prostate cancer that has spread to other parts of the body. Abiraterone operates by decreasing androgen production, a hormone that can promote the growth of prostate cancer cells.
      • Prednisone: It is a corticosteroid drug that can help to prevent the release of substances in the body that cause inflammation. In this trial, it is used in combination with abiraterone acetate to mitigate side effects and to further suppress the body’s production of androgens【15†source】.

      Have the Medicinal Substances Used in the Trial Been Previously Studied in Medicine?

      The clinical trial involves the following active substances:

      • Fuzuloparib: Fuzuloparib is being evaluated in this clinical trial in combination with Abiraterone Acetate and Prednisone (AA-P). It is used in the treatment group as an experimental drug in the form of capsules at a strength of 50 mg, with a dosing regimen of 150 mg taken twice daily by mouth (Bid, po). Fuzuloparib is being tested for its effectiveness in improving radiographic progression-free survival (rPFS) in subjects with metastatic Castration-Resistant Prostate Cancer (mCRPC), including those unselected for DNA damage repair deficiencies (DRD), as well as in mCRPC subjects harboring DRD[9†source].
      • Abiraterone Acetate: This is a known medication used in combination with Prednisone for treating prostate cancer. In this trial, Abiraterone Acetate is administered in the form of tablets at a strength of 250 mg, with a dosing regimen of 1000 mg taken once daily by mouth (Qd, po)[9†source].
      • Prednisone: Prednisone is a well-documented corticosteroid drug that has various indications, including anti-inflammatory and immunosuppressant effects. Within this trial, it is administered as tablets at a strength of 5 mg, with a dosing regimen of 5 mg taken twice daily by mouth (Bid, po)[9†source].

      Please note that a placebo version of Fuzuloparib is also used in the control arm of the trial in a separate group, named “Treatment group B,” to compare the effects against the active substances.


      Study ID

      CT-EU-00054169

      Recruitment status

      Recruting new patients

      Start of the trial

      3 years ago

      Study phase

      Phase
      III