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AuthorisedTherapeutic exploratory (Phase II)Interventional

Progression under Olaparib: a randomized phaSE II trIal with docetaxel or carboplatin-docetaxel DOublet in mCRPC patieNts

This study is for men with prostate cancer that has spread and needs further treatment. Researchers want to find out if certain chemotherapy combinations are more effective at stopping the cancer from getting worse. Participants will receive one of two treatment plans: docetaxel on its own, or a combination of carboplatin and docetaxel. The main goal is to see how many men in each treatment group have their cancer controlled, meaning it doesn't get worse, for at least four months. This research aims to improve future treatments for advanced prostate cancer.

At a glance

Status
Authorised
Phase
Therapeutic exploratory (Phase II)
Sponsor
Azienda Provinciale Per I Servizi Sanitari
Enrolment target
157
Start
18 Nov 2024

What is this study about?

This study is for men with prostate cancer that has spread to other parts of the body, also known as metastatic castrate-resistant prostate cancer. When cancer spreads, it can become trickier to treat, and doctors are always looking for better ways to help patients. In this study, doctors are comparing two treatment approaches to see which one works best.

Two groups of men will be created randomly, like flipping a coin. One group will receive a chemotherapy drug called docetaxel. The other group will receive a combination of two chemotherapy drugs: carboplatin and docetaxel. Both docetaxel and carboplatin are treatments used for cancer, but doctors want to see if combining them offers a better outcome for men with this type of advanced prostate cancer.

The main thing the doctors want to find out is how many men in each group have their cancer under control, meaning it doesn't get worse, for at least four months after starting treatment. They will also look at how long people live, how long it takes for the cancer to start growing again, and if there are any changes in the cancer itself. They'll also keep a close eye on any side effects and how people feel during the treatment using questionnaires.

Key takeaways

  • It's a study for widespread prostate cancer.
  • Compares two chemotherapy approaches: docetaxel alone vs. docetaxel with carboplatin.
  • Aims to find which treatment is better at controlling cancer for at least 4 months.
  • Participation involves regular hospital visits for treatment and tests.
  • Your health and well-being will be closely monitored throughout the study.

Who may be eligible?

This study is specifically designed for men with prostate cancer that has spread to other parts of the body. You must be at least 18 years old to take part.

There will be other specific health requirements that the doctors will check. For example, they'll need to make sure your other organs, like your kidneys and liver, are working well enough for you to safely receive the study treatments. Your general health will also be an important factor.

It's important to remember that this study is not for everyone with prostate cancer. The research team will carefully review your medical history and conduct tests to confirm if this particular study is right for you and if you meet all the necessary health criteria.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you a man?
  2. Are you 18 years old or older?
  3. Do you have prostate cancer that has spread?
  4. Has your prostate cancer become resistant to hormone therapy?
  5. Are you generally in good enough health to receive chemotherapy?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be randomly assigned to one of two treatment groups. This means you will either receive a drug called docetaxel, or a combination of docetaxel and carboplatin. You will receive these treatments by infusion, which means the drugs will be given directly into your bloodstream through a drip, just like other chemotherapy treatments.

During the study, you will have regular visits to the hospital or clinic to receive your treatment and to have various tests. These tests might include blood tests, scans, and physical examinations to see how the treatment is working and to check for any side effects. You will also be asked to fill out questionnaires about how you are feeling and your quality of life.

The study will monitor you closely over several months. The primary goal is to see how your cancer responds after four months, but monitoring for other outcomes like overall survival and any long-term effects will continue. The doctors and nurses will explain the full schedule of visits and tests if you are considering joining the study.

Potential risks and benefits

Taking part in this study might offer you a chance to receive treatments for your prostate cancer, and it could help doctors learn more about the best ways to treat this condition in the future. However, there's no guarantee that the treatment will work for you, and it might not be better than standard treatments. Like all medicines, the drugs used in this study (such as docetaxel and carboplatin, along with others like dexamethasone and loperamide to manage side effects) have potential side effects, which can vary from mild to severe. You will be told about all known risks before you agree to participate. You are free to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Unverified
    Italy

Common questions

What kind of cancer is this study for?

This study is for men with prostate cancer that has spread to other parts of the body and is no longer responding to hormone therapy.

What are the treatments being tested?

The study is comparing two chemotherapy options: docetaxel on its own, or a combination of docetaxel and carboplatin.

Will I get to choose which treatment I receive?

No, you will be randomly assigned to one of the two treatment groups, like drawing lots or flipping a coin.

What is the main goal of the study?

The main goal is to see which treatment best stops the cancer from growing for at least four months.

How long will I be involved in the study?

You will be monitored for at least four months to assess the treatment's effect, with follow-up for other outcomes over a longer period as determined by the study team.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

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