Active not recruitingPHASE2INTERVENTIONAL

ODM-201 vs Androgen Deprivation Therapy in Hormone naïve Prostate Cancer

This research is looking at a new drug called ODM-201 for men who have prostate cancer that hasn't been treated with hormone therapy before. It's a study where some men will receive ODM-201 and others will receive the usual hormone therapy, called ADT. The main goal is to check if ODM-201 is as good as ADT at reducing a blood marker called PSA (prostate-specific antigen) in the first 24 weeks. We'll also be looking at the side effects reported by patients and how safe the new drug is. This study will help us understand if ODM-201 could be another effective treatment option for prostate cancer.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Enrolment target

Start

01 Dec 2017

Estimated completion

01 Dec 2036

Prostate Cancer

What is this study about?

This study is for men with prostate cancer who have not yet received hormone therapy. We are comparing a new medication, ODM-201, with the standard hormone therapy currently used, which is called ADT (Androgen Deprivation Therapy). The main aim is to see if ODM-201 can reduce a specific blood marker related to prostate cancer, called PSA, by a similar amount to ADT over 24 weeks. This helps us understand how well the new drug works.

We also want to monitor the difference in side effects between the two treatments, using questionnaires filled out by patients. Your feedback on how you feel will be very important. We will also carefully check the safety of ODM-201 to make sure it is well-tolerated. This information is crucial for determining if ODM-201 could become a valuable new treatment option for prostate cancer.

About 250 men will take part in this study. Those who join will be randomly assigned, like flipping a coin, to either receive ODM-201 or standard ADT. The study will last for at least 24 weeks, but if the treatment is working well and not causing too many side effects, you might be able to continue taking ODM-201 for longer under the supervision of the study doctors.

Key takeaways

This study compares a new drug (ODM-201) with standard hormone therapy (ADT) for prostate cancer.
It aims to see if ODM-201 can lower PSA levels similarly to ADT and whether it has fewer side effects.
Participation involves either taking ODM-201 tablets or receiving ADT injections.
Your health will be closely monitored with regular check-ups, blood tests, and scans.
You can withdraw from the study at any time, for any reason.

Who may be eligible?

To join this study, you must be a man aged 18 or over with prostate cancer that needs ongoing hormone treatment for at least 24 weeks. Your cancer should not have spread to too many places, and it should not be causing you severe symptoms other than possibly urinary issues.

You typically won't be able to join if you've already had hormone therapy for your prostate cancer, such as previous surgery to remove your testes. We also need to check your general health, including your blood test results for organs like your liver and kidneys, to make sure you are well enough to take part and can safely take the study medication. You also need to be able to swallow tablets.

The research team will review your medical history and conduct tests to confirm if you meet all the specific requirements. If you have any mental health conditions or other situations that might make it hard for you to follow the study schedule, you might not be able to participate.

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.

Are you a man at least 18 years old with prostate cancer?
Has your prostate cancer not been treated with hormone therapy before?
Do you need ongoing hormone treatment for at least 24 weeks?
Are your prostate cancer symptoms mild, possibly only affecting urination?
Are you generally well and able to swallow tablets?
Do you have regular access to healthcare for clinic visits and tests?

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 either receive the new drug ODM-201 or the standard hormone therapy (ADT). ODM-201 is given as tablets, two 300mg tablets twice a day (a total of 1200mg daily) with food. The standard ADT is given as injections, usually once a month or every few months, depending on the type.

Initially, the treatment will last for 24 weeks. During this time, you'll have regular visits to the clinic for check-ups, blood tests (including PSA), scans, and to fill out questionnaires about how you're feeling and any side effects. If the treatment is helping you and you're not experiencing difficult side effects, you may be able to continue taking ODM-201 beyond 24 weeks until your disease progresses or side effects become too much. After 24 weeks, the choice of continuing treatment if you are in the ADT group will be made by your treating doctor.

Potential risks and benefits

Taking part in this study could offer some potential benefits. You would receive a new, unapproved medicine (ODM-201) or standard treatment, and your health would be closely monitored by a specialist medical team throughout the study. This close monitoring could help detect any changes in your condition early. However, there are also potential risks involved. New medicines can have unexpected side effects, and some may be serious. The standard ADT also has known side effects, such as hot flushes and tiredness. We cannot guarantee that either treatment will be effective for you. You are free to stop participating in the study at any time, for any reason, without it affecting your future medical care.

Locations (12)

Hopitaux Universitaires Bordet-Erasme - Hopital Universitaire Erasme
Verified postcode
Brussels, Belgium
Cliniques Universitaires Saint-Luc
Verified postcode
Brussels, Belgium
Universitair Ziekenhuis Gent
Verified postcode
Ghent, Belgium
CHU Dinant Godinne - UCL Namur
Verified postcode
Yvoir, Belgium
CHU de Dijon - Centre Georges-Francois-Leclerc
Verified postcode
Dijon, France
Gustave Roussy
Verified postcode
Villejuif, France
Azienda Ospedaliera Citta della Salute e della Scienza di Torino - Ospedale Molinette
Verified postcode
Torino, Italy
Institut Catala d'Oncologia - ICO Badalona - Hospital Germans Trias i Pujol
Verified postcode
Badalona, Spain
Hospital Universitario Ramon y Cajal
Verified postcode
Madrid, Spain
Hospital Universitario Virgen De La Victoria
Verified postcode
Málaga, Spain
Hospital Universitario de Salamanca
Verified postcode
Salamanca, Spain
Fundacion Instituto Valenciano De Oncologia
Verified postcode
Valencia, Spain

Common questions

What is ODM-201?

ODM-201 is a new medicine being tested to treat prostate cancer. It is taken as tablets.

What is ADT?

ADT stands for Androgen Deprivation Therapy. It's the standard hormone treatment for prostate cancer, designed to lower male hormones.

Why is PSA important in this study?

PSA (prostate-specific antigen) is a blood marker. For this study, we're checking its levels to see how well each treatment is working to control your prostate cancer.

Will I know which treatment I'm getting?

Yes, this is an 'open label' study, meaning both you and your doctor will know whether you are receiving ODM-201 or the standard hormone therapy (ADT).

How long will I be on the study treatment?

Initially, the study treatment will be for 24 weeks. If the new drug ODM-201 is working well, you might be able to continue taking it for longer.