What is the purpose of the study?

The purpose of this study is to investigate the stability timeframe of blood samples taken for prostate-specific antigen (PSA) testing, and to specifically identify if the blood test result remains the same after the recommended 24-hr period. This biomarker is used to test prostate cancer risk. We will be testing the PSA level at day zero, at 24-hr, at 48 hr and at 72hr.

What is prostate cancer?

The prostate is a satsuma sized gland located in the pelvis of men between the penis and bladder. The role of the prostate is to help with the production of semen. Prostate cancer is as a result of abnormal cells that have continued to grow. Prostate cancer usually develops slowly over years, with there being little to no signs or symptoms until the prostate gland starts to affect the urethra, a tube that allows urine to pass from the bladder to the penis via the prostate. Current research shows that 1 in 8 men will be diagnosed with prostate cancer during their lifetime.

What is PSA?

The PSA test is a blood test that measures the level of prostate specific antigen (PSA) in your blood. The prostate gland produces the protein PSA and sometimes it can leak out of the prostate into the bloodstream. A raised level of PSA can be an indication of prostate cancer but there are several other health problems that can cause it such as: an enlarged prostate (Benign Prostatic Hyperplasia), an inflamed prostate (Prostatitis), having a catheter, a relatively quick onset of unable pass urine like normal (acute urinary retention) and a urine infection.

Why have I been chosen?

You have volunteered as a biological male, over the age of 18 years, and you currently have no symptoms of prostate cancer (see below). It is important to speak to your GP if you do notice any of the below symptoms. Symptoms do not necessarily mean that you have prostate cancer, but, you should not take part in this study and you should see your GP.

     Symptoms:

• Needing to pass urine more frequently (including night-time)
• Needing to get to the toilet quickly to pass urine (urinary urgency)
• Difficulty in/taking longer to start to pass urine (urinary hesitancy)
• Flow of urine becomes weak
• Feeling that you have not completely emptied your bladder after you have been
• Blood in urine or semen
• Dribbling towards the end of passing urine
• Unexplained weight loss
• Lower back or bone pain

Do I have to take part?

It is up to you to decide whether or not to take part. If you decide to take part you are still free to change your mind or withdraw at any time and without giving a reason. This will not affect the standard of treatment or care you receive.

What will happen to me if I take part?

You will be required to visit Sankey Biolabs (Room G39, Daresbury Innovation Centre, Keckwick Lane, Daresbury, Warrington, WA4 4FS) on one occasion – this will be booked through a booking portal for you to choose your preferred date and time. During this appointment you will have a blood test where a vial of blood will be taken for each day that we will be testing the sample; therefore, there will be four vials in total. Before you take part, you should not have:

• An active urinary infection or within the previous six weeks’;
• Ejaculated in the previous 48 hrs;
• Exercised vigorously, for example, cycling in the previous 48 hrs;
• Had a urological intervention such as prostate biopsy in previous six weeks’.

What are the possible disadvantages and risks of taking part?

You may experience a short bout of soreness as a consequence of the venous blood draw which could last up to 48 hrs. After which symptoms will ease. This response is common and will have no lasting effect.

What are the possible benefits of taking part?

By taking part in this study, you will have the opportunity to have your PSA tested. If you do have a raised PSA, PAM Wellness will contact you within three to four weeks’ of the study by email to inform you of this. You will not be contacted if you have a normal PSA level.

What if something goes wrong?

If you wish to complain or have any concerns about any aspect of the way you have been approached or treated during the course of this study, please contact [email protected]   

Will my taking part in the study be kept confidential?

All information which is collected about you during the course of the research will be kept strictly confidential.

What will happen to the results of the research study?

The results will be written up into an internal validation study. If you do have a raised PSA result at day zero, PAM Wellness will contact you within three to four weeks’ of the study by email to inform you of this. If you have a raised PSA result after day zero, PAM Wellness will contact you within three to four weeks’ of the study by email to inform you of this, and advise you that this result is part of a study and it is your responsibility to follow up with your GP. You will not be contacted if you have a normal PSA level.

Who is organising and funding the research?

The research is conducted by PAM Wellness, part of PAM Group.

Who may I contact for further information?

If you would like more information about the research before you decide whether or not you would be willing to take part, please contact:

Email: [email protected]

Thank you for your interest in this research.