Living with metastatic prostate cancer is not always easy and, at times, can feel overwhelming.
Despite recent advances in the treatment of metastatic prostate cancer, the need remains for more treatments to be available.
Your doctor may have mentioned the TALAPRO-2 clinical research study, or perhaps you found your way here by yourself, either way thank you for your interest in our study.
The TALAPRO-2 study will assess a potential treatment option and we're currently looking for men to take part. This website will give you an overview of the study and you can run a quick check to see if you could be eligible to join, should you decide the study is right for you. If you have any further questions, please contact your doctor.
Clinical research studies are an essential part of learning more about diseases like cancer, they bring people together to help compare investigational medicines with current standard of care treatments.Interested? Find out more
The TALAPRO-2 study will assess whether a study drug is safe and effective when given as a possible treatment to patients with metastatic castration-resistant prostate cancer alongside enzalutamide, a treatment that has already been approved for this condition.Join our study
If you join the TALAPRO-2 study you can expect to take six capsules by mouth, once a day, for an average of 85 weeks (this may be longer or shorter depending on how your cancer responds to study treatment). You will either be given the study drug and enzalutamide or a placebo (inactive medicine) and enzalutamide; neither you or the study team will know which study treatment you are taking. It is normal practice in clinical research studies to measure results against a placebo in order to be sure that it's the study drug that is responsible for any benefits seen.
If you would like to join this study and we feel it could be right for you, we will ask you to attend one or more screening visits at the clinic. During this visit, we will ask you some health questions, take blood samples, perform an electrocardiogram (ECG), perform CT/MRI and bone scans and review your recent prostate-specific antigen results. Genetic testing to see if you carry DNA repair defects will require tumor tissue sample and a blood sample. If a tissue sample is not already available, a biopsy will need to be performed.
So that we can monitor how you are responding to the study treatment, you will need to make regular visits (about 25) to the clinic for health assessments such as medical questionnaires, physical examinations, blood samples and CT/MRI and bone scans. You will be required to submit a saliva sample for genetic testing. We will also give you an electronic study diary to take home so that you can record your daily dose of the study drug. You will also complete questionnaires about any pain you experience due to your prostate cancer and record any medication you took to relieve the pain.
After you stop taking your study treatment, we will continue to contact you every 12 weeks by telephone to see how you are doing.
Plus you have not received:
There are other requirements for participation in the study. The study doctor will be able to explain these to you.
We need to check a few things before we can say whether or not the study may be right for you.
There are two steps to the pre-screening process.
Please answer the questions below and enter your contact details.
Please be assured that any information you provide will be kept confidential and will not be shared, discussed or sold to any third party organization.
If your answers indicate that the study may be right for you, and you select a study site, your contact information will be forwarded to that study team.
Contacting a study site does not mean you have to join the study, the study site can give you more information and answer any questions you may have.
If you are not eligible to join the study, all information that you provided will be deleted from our database.
Please take a moment to answer these questions to find out if you may be eligible to join the TALAPRO-2 study.
You may complete this form on behalf of an interested participant, however, someone from the study site will need to speak with them directly in order to further determine if they may be eligible.
Reference: 1. Scher HI et al. PLoS One 2015; 10(10): e0139440.