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Study on Docetaxel and Carboplatin-Docetaxel Combination for Prostate Cancer Patients Progressing After Olaparib Treatment

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What is this study about?

This clinical trial is focused on studying treatments for prostate cancer, specifically a type known as metastatic castration-resistant prostate cancer (mCRPC). The study involves patients whose cancer has progressed after treatment with a medication called olaparib. The trial will compare two treatment options: one group will receive a combination of docetaxel and prednisone with carboplatin, while the other group will receive only docetaxel and prednisone. The purpose of the study is to determine if the combination treatment is more effective than the treatment without carboplatin.

Participants in the study will be randomly assigned to one of the two treatment groups. The study will last for a period of time during which patients will receive their assigned treatment and be monitored for any changes in their condition. The study aims to see how many patients do not experience disease progression after four months of treatment. Other aspects being observed include the length of time patients live without the disease getting worse, overall survival, and any side effects experienced during the study.

This trial is important for understanding better treatment options for patients with mCRPC who have already been treated with an androgen-receptor signaling inhibitor (ARSI) and olaparib. The study will help determine if adding carboplatin to the standard treatment of docetaxel and prednisone can improve outcomes for these patients. Participants will be closely monitored throughout the study to ensure their safety and to gather valuable information about the effectiveness of the treatments being tested.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria such as a confirmed diagnosis of prostate cancer and previous treatments.

Written informed consent is required to participate in the trial.

2 treatment assignment

Participants are randomly assigned to one of two treatment groups: Arm A or Arm B.

Arm A receives a combination of docetaxel, prednisone, and carboplatin.

Arm B receives docetaxel and prednisone only.

3 treatment administration

In Arm A, docetaxel is administered as an intravenous infusion, prednisone is taken orally, and carboplatin is given as an intravenous infusion.

In Arm B, docetaxel is administered as an intravenous infusion, and prednisone is taken orally.

The treatment cycle is repeated every three weeks.

4 monitoring and assessments

Regular monitoring of health status and response to treatment is conducted.

Assessments include imaging tests, blood tests, and questionnaires to evaluate quality of life.

5 evaluation of treatment effectiveness

The primary goal is to determine the rate of patients without disease progression after four months.

Secondary goals include measuring progression-free survival, overall survival, and response rates.

6 completion of the trial

The trial is expected to conclude by September 2026.

Final assessments are conducted to evaluate the long-term effects and outcomes of the treatments.

Who Can Join the Study?

  • Must have a confirmed diagnosis of prostate cancer through a tissue sample test.
  • Must have a performance status of less than 2 on the ECOG scale, which measures how well you can perform daily activities.
  • Must be able to complete a quality of life questionnaire.
  • Must provide written informed consent to participate in the study.
  • Must have Metastatic Castration Resistant Prostate Cancer (mCRPC), which means the cancer has spread and is not responding to treatments that lower testosterone.
  • Must have a previously detected BRCA mutation, which is a change in a gene that can affect cancer risk.
  • Must have been treated for mCRPC with an androgen-receptor signaling inhibitor (ARSI) and then with a drug called olaparib.
  • Must have shown signs of cancer progression while on olaparib, such as:
    • Increase in measurable disease size.
    • New cancer lesions appearing, especially in bones.
    • Rising PSA levels, which is a protein made by the prostate, with specific criteria for increase.
  • Must have effective castration, meaning low testosterone levels, achieved by surgery or medication.
  • Must be at least 18 years old.

Who Cannot Join the Study?

  • Patients who have not been diagnosed with prostate cancer cannot participate. Prostate cancer is a type of cancer that occurs in the prostate, a small gland in men that produces seminal fluid.
  • Patients who have not previously been treated with an androgen-receptor signaling inhibitor (ARSI) followed by olaparib are excluded. ARSI is a type of medication that blocks the effects of male hormones, and olaparib is a drug used to treat certain types of cancer.
  • Only male patients are eligible for this study.
  • Patients who are considered part of a vulnerable population are not eligible. A vulnerable population includes groups who may have limited ability to protect their own interests, such as children or those with certain disabilities.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
IRCCS Humanitas Research Hospital Rozzano Italy

Other Sites

Site Name City Country Status
Azienda Ospedaliero-Universitaria Maggiore Della Carita Novara Italy
Azienda Sanitaria Locale Cn2 Alba-Bra Alba Italy
Istituto Oncologico Veneto Padua Italy
Centro Di Riferimento Oncologico Di Aviano Aviano Italy
Azienda Ospedaliero Universitaria Di Modena Modena Italy
Azienda Sanitaria Universitaria Friuli Centrale Udine Italy
Azienda Ospedaliera Ordine Mauriziano Di Torino Turin Italy
Azienda Sanitaria Locale Napoli 2 Nord Frattamaggiore Italy
Aolzzio Ovcqjkebsin Utciiqtejefut Ouavqxsj Rfnkvmx Foggia Italy
Isywej Izclasyp Fhzdxeexawdad Olynagccstl Rome Italy

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

Trial status

Country Status Recruitment Start
Italy Italy
Not yet recruiting
01.09.2024

Trial locations

Investigated drugs:

Docetaxel is a medication used in this trial to treat patients with metastatic castration-resistant prostate cancer (mCRPC). It works by interfering with the growth of cancer cells, slowing down or stopping their spread in the body.

Prednisone is a steroid used alongside other medications in this trial. It helps reduce inflammation and can also help manage some side effects of cancer treatment, improving the patient’s comfort and quality of life.

Carboplatin is a chemotherapy drug used in combination with docetaxel and prednisone in one arm of the trial. It works by damaging the DNA of cancer cells, which prevents them from dividing and growing, ultimately leading to their death.

Investigated diseases:

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 other parts of the body, such as bones and lymph nodes. Hormonal changes and genetic factors can influence its development. Monitoring and regular check-ups are crucial for managing its progression.

Trial ID:
2023-503676-25-01
Protocol code:
POSEIDON
Trial Phase:
Therapeutic exploratory (Phase II)

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