Not recruiting

Study on Sildenafil and Vacuum Erection Device Therapy for Men with Prostate Cancer Undergoing Nerve-Sparing Surgery

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on helping men recover their ability to have natural erections after undergoing a specific type of surgery for prostate cancer. The surgery, known as nerve-sparing robot-assisted radical prostatectomy, aims to remove the prostate while preserving the nerves that are important for erectile function. The study will test two different approaches to help men regain their erectile function. One group will take a daily dose of sildenafil, a medication commonly used to treat erectile dysfunction, along with using a vacuum erection device (VED) five times a week. The other group will take sildenafil on demand, up to three times a week, without the use of a VED.

The purpose of the study is to determine which approach is more effective in helping men achieve good unassisted erections 24 months after surgery. Participants will be followed for a total of 24 months, with regular check-ins to monitor their progress. The study will also look at other aspects of sexual health and quality of life, such as orgasmic function, feelings of masculinity, and the impact on partners. The trial will include the use of questionnaires to gather information on these topics.

In addition to sildenafil, another treatment option being studied is Androskat, which is a solution for injection containing two active substances: phentolamine mesilate and papaverine hydrochloride. This treatment is administered through an injection directly into the penis. The study will compare the effectiveness and side effects of these treatments to determine the best approach for penile rehabilitation after prostate cancer surgery.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Beginning of the trial
Upon joining the study, you will be randomly assigned to one of two groups. This is to compare different approaches to penile rehabilitation after prostate surgery.
Step 2
Medication and therapy
If you are in the first group, you will take sildenafil daily. The dosage will be either 75 mg or 100 mg, depending on your specific needs. You will also use a vacuum erection device (VED) five times a week. This will continue for 12 months.
If you are in the second group, you will take sildenafil on demand, up to three times a week, with the same dosage options of 75 mg or 100 mg. This will also continue for 12 months.
Step 3
Follow-up assessments
Throughout the trial, your progress will be monitored. You will have assessments at 6, 9, 12, 18, and 24 months to evaluate your erectile function and overall health.
These assessments will include questionnaires about your sexual health and quality of life. Blood samples may be taken to check testosterone levels and other health indicators.
Step 4
End of the trial
At the end of the 24-month period, a final assessment will be conducted to determine the effectiveness of the rehabilitation program you followed.
The goal is to see if you have achieved good unassisted erections and to evaluate any changes in your sexual health and quality of life.

Who can join the trial?

13 criteria

Age must be between 18 and 75 years old.
Must be motivated to participate in a program to help improve erections.
Must have had at least one side of the prostate nerves spared during surgery, or a specific score (FP score) of 5 or more.
Before diagnosis, must have had erections good enough for intercourse.
Must have a penis that developed naturally, without any surgical changes.
Before diagnosis, must have had a score of 22 or more on a questionnaire about erectile function (IIEF-EF), with or without medication. If no partner or no penetrative sex, a different score (EPIC) of 83 or more is used.
Must be willing to give blood samples to check testosterone levels, blood sugar (Hb1Ac), liver function, and cholesterol levels.
Testosterone levels must be at least 9 nmol/l, measured before or after surgery. Blood should be taken before 11 am and before breakfast, without symptoms like low sex drive, low energy, or problems with orgasm.
Must sign a form agreeing to participate in the study.
Must have a confirmed diagnosis of prostate cancer through a tissue sample (histology).
Must be scheduled for prostate surgery (RP) with the plan to spare at least one side of the nerves.
Must not have cancer that has spread to other parts of the body (non-metastatic, cN0M0).
Before surgery, must have had erections good enough for intercourse.

Who cannot join the trial?

8 criteria

Patients who have a different type of cancer other than prostate cancer.
Patients who are not within the specified age range for the study.
Patients who are not able to follow the study procedures or take the study medication as required.
Patients who have a medical condition that might interfere with the study results.
Patients who are currently participating in another clinical trial.
Patients who have a history of allergic reactions to the study medication.
Patients who are pregnant or breastfeeding.
Patients who have a significant mental health condition that might affect their ability to participate in the study.

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Verified sites

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Catharina Ziekenhuis Stichting
Verified
Eindhoven, The Netherlands
St. Antonius Ziekenhuis
Verified
Nieuwegein, The Netherlands
Stichting Radboud University Medical Center
Responsive
Nijmegen, The Netherlands

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Investigated drugs

Sildenafil
is a medication used in this clinical trial to help improve erections. It works by increasing blood flow to the penis, which can help men achieve and maintain an erection. In this study, participants are taking Sildenafil either daily or as needed to see which method is more effective in helping them regain good unassisted erections after prostate surgery.
VED therapy
, or Vacuum Erection Device therapy, is another treatment used in this trial. It involves using a device that creates a vacuum around the penis, drawing blood into it and helping to produce an erection. Participants use this therapy several times a week to see if it helps improve their ability to have natural erections over time.

What is already known about the treatment

Sildenafil – Sildenafil is administered orally in the form of tablets and is used to help improve erectile function. It is currently being studied in clinical trials for its effectiveness in penile rehabilitation after prostate surgery. The main therapeutic indication for Sildenafil is to treat erectile dysfunction, particularly in patients recovering from prostate cancer surgery. At the molecular level, Sildenafil works by increasing blood flow to the penis, which helps achieve and maintain an erection. It does this by inhibiting an enzyme called phosphodiesterase type 5 (PDE5), which results in the relaxation of blood vessels. Sildenafil is classified as a phosphodiesterase inhibitor.

Investigated diseases

Prostate cancer – Prostate cancer is a disease where cells in the prostate gland grow uncontrollably. The prostate is a small gland in men that produces seminal fluid. As the cancer progresses, it may spread to nearby tissues or other parts of the body. Initially, prostate cancer may not cause noticeable symptoms. Over time, it can lead to difficulties with urination, blood in the urine, or pelvic discomfort. The progression of the disease can vary, with some cases remaining slow-growing and others advancing more rapidly.