Active not recruitingPHASE3INTERVENTIONAL

A Trial Comparing Docetaxel 75 mg/m2 (3w) Versus Docetaxel 50 mg/m2 (2w) in Combination With Darolutamide + ADT in mHSPC Patients

This research trial is for men with advanced prostate cancer that is still sensitive to hormone treatment. We're looking at two different ways to give the chemotherapy drug Docetaxel, in combination with Darolutamide and standard hormone therapy (ADT). One group will receive Docetaxel every three weeks, while the other will receive a slightly lower dose every two weeks. The main goal is to see which schedule leads to fewer serious side effects. By understanding this, doctors can give patients the most effective treatment with the fewest problems. The study will also follow patients to see how their cancer progresses over time.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Jena University Hospital

Enrolment target

250

Start

16 May 2023

Estimated completion

01 Jan 2027

Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

What is this study about?

This study is a research trial for men who have metastatic hormone-sensitive prostate cancer (mHSPC). This means the prostate cancer has spread to other parts of the body but still responds to hormone therapy. The trial is comparing two ways of giving a chemotherapy drug called Docetaxel, which is already used to treat prostate cancer. All patients in the study will also receive a standard hormone treatment (ADT) and another drug called Darolutamide.

Imagine you have a headache and can take one strong painkiller once, or a slightly weaker one more often. This study is similar, but for cancer treatment. Doctors want to understand if giving Docetaxel in a slightly different schedule will reduce serious side effects, while still being effective. One group will get a standard dose of Docetaxel every three weeks, and the other will get a slightly lower dose every two weeks. Both groups will have 6 total treatments of Docetaxel.

The main thing the doctors are checking is how many serious side effects (called Grade 3-5 adverse events) patients experience with each Docetaxel schedule. They will also look closely at a specific side effect called neutropenia, which is a drop in certain white blood cells. By finding out which treatment schedule causes fewer serious problems, doctors can make better decisions about how to treat patients with mHSPC in the future, aiming for the best possible quality of life.

Key takeaways

Compares two Docetaxel schedules for advanced prostate cancer.
Patients also receive Darolutamide and standard hormone therapy.
Main goal is to identify fewer serious side effects.
Treatment is given for 6 cycles of Docetaxel.
You will be randomly assigned to one of two treatment groups.

Who may be eligible?

This study is looking for men at least 18 years old who have prostate cancer that has spread to other parts of their body, and it's still responding to hormone treatment. Your doctor will need to confirm your cancer diagnosis and that it has spread through scans like bone scans, CT scans, or MRI scans.

You must be healthy enough to receive the study medications (Docetaxel, Darolutamide, and standard hormone therapy) in your doctor's opinion. You also need to have started hormone therapy recently, no more than 12 weeks before joining the study.

Important things that would mean you can't join include having only lymph node metastases (spread to lymph nodes) without other types of spread. Also, your blood test results and liver/kidney function need to be within a certain healthy range.

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.

Am I a man aged 18 or older?
Do I have prostate cancer that has spread to other parts of my body?
Is my prostate cancer still responsive to hormone treatment?
Have I recently started hormone therapy (within the last 12 weeks)?
Am I generally healthy enough for these treatments, as judged by my doctor?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be assigned by chance (like flipping a coin) to one of two groups. Both groups will receive the standard hormone therapy (ADT) and Darolutamide. Additionally:

* One group will receive 6 doses of Docetaxel every three weeks. * The other group will receive 6 doses of Docetaxel every two weeks.

After you finish your 6 Docetaxel treatments, you will continue taking Darolutamide and ADT, and your health will be monitored regularly. You'll have regular appointments for check-ups, blood tests, and scans to see how you are doing and how the treatment is working. The study will continue to follow you until your cancer shows signs of becoming resistant to hormone therapy. We expect you will need to attend regular clinic visits for check-ups, blood tests, and scans throughout the treatment and follow-up period.

Potential risks and benefits

Taking part in this study might offer a chance to receive active treatment for your cancer, and potentially help researchers find better ways to treat metastatic hormone-sensitive prostate cancer in the future. However, there are potential risks, including side effects from the medications like Docetaxel, Darolutamide, and ADT. These can range from mild to serious and will be explained in detail by your study doctor. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (43)

Ordensklinikum Linz GmbH, Elisabethinen
Verified postcode
Linz, Austria
Krankenhaus der Barmherzigen Brüder
Verified postcode
Vienna, Austria
Nationales Centrum für Tumorerkrankungen (NCT) Heidelberg
Verified postcode
Heidelberg, Germany
Klinikum Wetzlar
Verified postcode
Wetzlar, Germany
Med. Hochschule Hannover
Verified postcode
Hanover, Germany
Urologische Klinik München Planegg
Verified postcode
Planegg, Germany
Urologicum Duisburg
Verified postcode
Duisburg, Germany
Brüderkrankenhaus St- Josef Paderborn
Verified postcode
Paderborn, Germany
Urologisches Zentrum Euregio
Verified postcode
Würselen, Germany
Krankenhaus Martha-Maria Halle Dölau gGmbH
Verified postcode
Halle, Germany
Praxisgemeinschaft f. Onkologie & Urologie
City only
Wilhelmshaven, Germany
University Hospital Jena, Department of Urology
Verified postcode
Jena, Germany

Common questions

What is 'hormone-sensitive prostate cancer'?

This means your prostate cancer generally responds well to treatments that lower male hormones, like testosterone.

What is Docetaxel?

Docetaxel is a type of chemotherapy drug used to treat various cancers, including prostate cancer. It works by stopping cancer cells from growing and dividing.

What is Darolutamide?

Darolutamide is a newer hormonal treatment that blocks male hormones from reaching cancer cells, helping to slow cancer growth.

What does 'randomized' mean in a study?

It means you will be assigned to a treatment group by chance, like drawing names from a hat. This helps ensure the study results are fair and reliable.

How long will I be followed in this study?

You will receive Docetaxel treatment for about 12-18 weeks (6 cycles), and then continue Darolutamide and ADT. You will be monitored until your cancer shows signs of progressing.