Actively Recruiting
PEnile ReHABilitation After Nerve Sparing Robot-assisted Radical Prostatectomy for Prostate Cancer 2.0, a Multicentre, Randomized Clinical Trial (PEHAB-II)
Led by The Netherlands Cancer Institute · Updated on 2025-03-13
198
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
Sponsors
T
The Netherlands Cancer Institute
Lead Sponsor
A
Antoni van Leeuwenhoek Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating two different rehabilitation approaches to improve recovery of erectile function in men who have undergone nerve-sparing robot-assisted radical prostatectomy for localized prostate cancer. This randomized trial aims to find the best penile rehabilitation strategy to reduce postoperative erectile dysfunction, which remains common despite nerve-sparing surgery. The study is conducted at multiple centers in the Netherlands and focuses on patients aged 18 to 70 years with non-metastatic prostate cancer. Participants will be randomly assigned to one of two groups: one receiving a daily dose of 75-100 mg Sildenafil combined with vacuum device therapy for 10 minutes a day, five times a week, for 12 months; and the other receiving on-demand Sildenafil therapy up to three times per week. After the first year, treatment intensity may be adjusted for an additional year using on-demand Sildenafil, vacuum device therapy, or optional intracavernosal injection therapy, depending on patient preference. The study treatment period lasts 24 months, concluding with a one-month drug washout before final assessments. Participants will attend baseline and follow-up evaluations every three months via phone, online surveys, and outpatient clinic visits lasting about 20 minutes. They will complete questionnaires on sexual function and quality of life and provide one blood sample at baseline for hormone and metabolic testing. Researchers will monitor erectile function over 24 months using validated questionnaires, assess side effects, adherence, and quality of life. The primary outcome is recovery of an adequate unassisted erection at 24 months post-surgery.
CONDITIONS
Brief Title
PEnile ReHABilitation After Nerve Sparing Robot-assisted Radical Prostatectomy for Prostate Cancer 2.0 (PEHAB-II)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male patients aged over 18 years and under 70 years
- Naturally developed penis without prior surgical interventions
- Histologically confirmed prostate cancer
- Scheduled for radical prostatectomy with at least one-sided nerve-sparing procedure
- Non-metastatic disease (cN0M0)
- Pre-operative erections good enough for intercourse
- Motivated to participate in a penile rehabilitation program
- Unilateral nerve-sparing or Fascia Preservation score of 5 or higher
- Pre-diagnostic IIEF-EF score of 22 or higher, with or without PDE5 inhibitors
- For patients without penetrative sex, EPIC-erection score of 83 or higher
- Willing to provide blood samples for hormone and metabolic tests
- Testosterone level of at least 12 nmol/l measured pre- or post-operatively
- Signed informed consent form
You will not qualify if you...
- Previous pelvic radiation therapy
- Current androgen deprivation therapy
- Blood disorders such as sickle cell anemia, leukemia, or bone marrow tumors
- Severe heart failure (NYHA class 3 or higher)
- Conditions increasing susceptibility to vasodilators or unstable angina
- Use of nitrate oxide for coronary artery disease
- Low blood pressure (below 90/50 mmHg)
- Recent stroke or heart attack
- Blood clotting disorders or prolonged erections
- Neurological diseases including TIA, stroke, Parkinson's, or polyneuropathy
- Allergy to Sildenafil
- Vision loss in one eye from non-arteritic anterior ischemic optic neuropathy
- Severe liver impairment
- Hereditary retinal degenerative disorders such as retinitis pigmentosa
- Use of alpha-blockers unless discontinued before participation
- Inability to read or speak Dutch
- Pathological tumor stage greater than pT3b
- Adjuvant radiotherapy or hormonal therapy
- Severe penile deformity preventing vacuum device use
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for baseline blood samples and assessments
Duration - Up to 24 months with initial 12 months of intensive or less intensive therapy followed by 12 months of adjusted treatment
Participants receive penile rehabilitation therapy after nerve-sparing radical prostatectomy. This includes either daily doses of Sildenafil combined with vacuum device therapy or on-demand Sildenafil use, followed by adjusted therapy options based on recovery and preference.
Outpatient clinic visits and telephonic or online assessments every 3 months
Duration - 1 month
Participants undergo a drug washout period one month before the end of the study to assess erectile function without medication, followed by final evaluations.
1 visit (in-person) for drug washout and final assessment
Trial Site Locations
Total: 3 locations
1
Canisius Wilhelmina Ziekenhuis
Nijmegen, Gelderland, Netherlands, 6532SZ
Not Yet Recruiting
2
Antoni van Leeuwenhoek hospital, Netherlands Cancer Institute
Amsterdam, North Holland, Netherlands, 1066CX
Actively Recruiting
3
Maasstad ziekenhuis
Rotterdam, South Holland, Netherlands, 3079DZ
Not Yet Recruiting
Research Team
I
Inge Cox, MD
M
Melianthe Nicolai, MD/PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here