RecruitingNAINTERVENTIONAL

EFFICACY OF INTRAOPERATIVE ARISTA POLYSACCHARIDE APPLICATION ON THE POSTOPERATIVE BLOOD LOSS IN PATIENTS UNDERGOING RARP FOR THE TREATMENT OF PROSTATE CANCER

This research is investigating if a special gel, ARISTA™ AH, can help men who are having surgery for prostate cancer. The surgery, called a robot-assisted radical prostatectomy, involves removing the prostate. Researchers want to see if applying this gel to specific areas during the operation helps to reduce bleeding after the surgery. They're also looking at whether it might help men maintain better erectile function within 3, 6, and 12 months after the operation. This is an important study because reducing bleeding and improving quality of life, like erectile function, are key goals for men recovering from prostate cancer treatment.

At a glance

Status

Recruiting

Phase

Sponsor

St. Antonius Hospital Gronau

Enrolment target

362

Start

16 Jan 2025

Estimated completion

30 Jan 2027

Prostate Cancer (Adenocarcinoma)Blood Loss, Postoperative Erectile Function

What is this study about?

When men undergo surgery for prostate cancer, especially an operation called a robot-assisted radical prostatectomy, one of the challenges can be managing bleeding during and after the procedure. Another important concern for many men is how the surgery might affect their erectile function afterwards. This research aims to see if a specific product, a gel called ARISTA™ AH, can make a positive difference in these areas.

The study involves applying this gel to certain nerves near the prostate, which are important for sexual function, immediately after the prostate is removed. The main goal is to find out if men who receive the gel have less bleeding after surgery compared to those who don't. Doctors will measure this by checking their blood levels (hemoglobin) after the operation. If the gel helps reduce bleeding, it could mean a quicker and smoother recovery.

Additionally, the researchers are keenly interested in whether applying this gel might help protect the nerves responsible for erectile function. They will be checking in with participants at 3, 6, and 12 months after surgery to see if there are any differences in erectile function between the group who received the gel and the control group. Understanding this could potentially lead to better outcomes and a higher quality of life for men after prostate cancer surgery.

Key takeaways

This study investigates a gel (ARISTA™ AH) during prostate cancer surgery.
It aims to see if the gel reduces bleeding after the operation.
Researchers will also check if it helps improve erectile function over a year.
Participation involves your planned surgery and follow-up questionnaires.
You won't know if you received the gel or not during the study.
The study helps understand better ways to recover from prostate cancer surgery.

Who may be eligible?

To join this study, you generally need to be a man aged between 45 and 68 years old, and have prostate cancer that’s going to be treated with robot-assisted surgery. It’s important that your cancer hasn’t spread to other parts of your body, and you shouldn’t have had any other treatments for your prostate before, like radiation or different types of surgery.

Before the surgery, you should be able to control your bladder well, and if you're in the group that will potentially receive the gel, your erectile function should be in a moderate range. The study is particularly looking for men whose nerves important for sexual function can be preserved during the operation, either on one or both sides.

You wouldn't be able to join if you have very aggressive prostate cancer, severe learning difficulties, or certain other serious health conditions like Peyronie's disease, severe depression, or if you can't take certain medications used for erectile dysfunction.

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 between 45 and 68 years old?
Do you have prostate cancer requiring robot-assisted surgery?
Has your prostate cancer not spread to other parts of your body?
Have you not had previous prostate treatments like radiation or surgery?
Are you able to control your bladder well before surgery?
Is your erectile function in a moderate range if you're in the initial screening group?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would have your prostate cancer surgery as planned. During the operation, some participants will have the ARISTA™ AH gel applied to specific areas after their prostate is removed, while others will not – this will be decided randomly, like flipping a coin. You wouldn’t know which group you are in. After surgery, your doctors will routinely check your blood for bleeding. You would also have check-ups at 3, 6, and 12 months after the surgery to assess your erectile function using a questionnaire. The total duration of your active participation, including follow-up for erectile function, would be 12 months. All standard care associated with your surgery and recovery would continue as usual.

Potential risks and benefits

Taking part in any research study has potential benefits and risks. A potential benefit of this study could be that applying the ARISTA™ AH gel reduces your risk of bleeding problems after prostate surgery, which might lead to a smoother recovery. There's also a chance it could help preserve your erectile function, though this isn't guaranteed. Unknown risks associated with the gel are possible, but the gel is a hemostat agent that is already used in other surgical settings. You have the right to withdraw from the study at any time without affecting your medical care.

Locations (3)

Martini Klinik am UKE GmbH
Verified postcode
Hamburg, Germany· Recruiting
St. Antonius-Hospital Gronau GmbH, Klinik für Urologie, Urologische Onkologie und Roboter-assistierte Chirurgie
Verified postcode
Gronau, Germany· Recruiting
Klinik und Poliklinik für Urologie des Universitätsklinikums Leipzig
Verified postcode
Leipzig, Germany· Recruiting

Common questions

What is ARISTA™ AH gel?

ARISTA™ AH is a special gel that surgeons use to help control bleeding during an operation.

What is robot-assisted radical prostatectomy?

This is a type of surgery performed using robotic tools to remove the prostate gland when a man has prostate cancer.

Will I know if I'm getting the gel or not?

No, you won't know whether you received the gel or not. This is to ensure the study results are fair and unbiased.

Why is erectile function being checked?

Erectile function can sometimes be affected by prostate cancer surgery, and researchers want to see if the gel might help protect it.

How long will I be involved in the study?

You'll be part of the study for 12 months after your surgery, mainly for follow-up assessments of your erectile function.

How to find out more

Sami-Ramzi Leyh-Bannurah, PD. Dr.

sami-ramzi.leyh-bannurah@uke.de +49741051305 Official trial record

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