PEnile ReHABilitation After Nerve Sparing Robot-assisted Radical Prostatectomy for Prostate Cancer 2.0 (PEHAB-II)

NCT06875258 | Recruiting Phase 4

• 1 other identifier: M23PB2
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 3

Brief Summary

The PEHAB-II study is prospective, randomized trial designed to assess the effect of two different rehabilitation strategies on the recovery of erectile function in nerve sparing prostatectomy patients. The two rehabilitation strategies consist of 1)12 months daily doses of 100 mg Sildenafil combined with vacuum device (VED) therapy for 10 minutes a day, five times a week or 2) Standard of care: monotherapy with an on-demand dosage of 100mg Sildenafil. The study will be performed in multiple centers in the Netherlands.

Conditions

Erectile Dysfunction Following Radical Prostatectomy

Keywords

Penile rehabilitation; Vacuum pump device; Sildenafil; Nerve sparing prostatectomy; Quality of life; Sexual quality of life; Prostate cancer survivorship

Outcome Measures

Primary Outcomes (1)

• Erectile function without tools

  To determine the difference in rates of patients achieving good unassisted erections at 24 months of follow-up after receiving either 12 months of 75/100mg Sildenafil daily and VED therapy 5 times a week or 75/100mg Sildenafil on demand (≤3 times a week) as a penile rehabilitation program.

  24 months

Secondary Outcomes (5)

• Erectile Function

  Varying from 6-24 months

• Health en sexual quality of life:

  12 and 24 months

• Adherence

  12 months

• Best tool to evaluate erectile function:

  6 months

• Side effects

  12 months

Study Arms (2)

Intensive rehabilitation arm

EXPERIMENTAL

12 months daily doses of 75/100 mg Sildenafil combined with vacuum device (VED) therapy for 10 minutes a day, five times a week. Followed by one year on demand use of Phosphodiesterase type 5 inhibitors (PDE5i) (max. 3 times/a week) and/or VED (max. 3 times/a week) and/or Injection therapy (max once/ a week) (based on patients preference and needs).

Drug: Sildenafil; Device: Erectile vacuum device

Less intensive rehabilitation arm

ACTIVE COMPARATOR

Monotherapy with an on-demand dosage of 75/100mg Sildenafil (max. 3 times/a week). Followed by one year on demand use of PDE5i (max. 3 times/a week) and/or VED and/or Injection therapy (max once/ a week). (based on patients preference and needs).

Drug: Sildenafil

Interventions

Sildenafil DRUG

Taken daily or on demand. First two weeks dosage of 75mg to manage side effects. If side effects are bearable, dosage will be adjusted to 100mg

Also known as: Mylan

Intensive rehabilitation arm; Less intensive rehabilitation arm

Erectile vacuum device DEVICE

5 days a week, generating 5 erections per day

Also known as: Active 3 Erection System

Intensive rehabilitation arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pre-screening eligibility criteria
• Age \> 18 years and \< 70 years
• Patients who have a penis that has developed naturally, without surgical interventions.
• Histologically confirmed PCa
• Scheduled for RP as primary treatment with the intention of at least a one-sided nerve-sparing procedure.
• Non-metastatic disease (cN0M0)
• Pre-operative erections good enough for intercourse (anamnestic)
• Motivated to participate in a penile rehabilitation program
• To be eligible to participate in this study, a subject must meet all of the following post- operative criteria:
• All of the above-mentioned pre-screening eligibility criteria
• At least unilateral nerve-sparing or if available Fascia Preservation (FP) score =\>5
• A pre-diagnostic anamnestic erection that was good enough for intercourse.
• A pre-diagnostic IIEF-EF\>=22 with or without PDE5i. For patients without a partner or did not participate in penetrative sex we use accumulated score of EPIC- erectile function; Q8b, Q9 and Q10 \>=83.
• Willing to provide one blood sample to determine testosterone level, hemoglobin 1Ac, liver enzymes and lipid profile
• Testosterone levels of at least \>=12 nmol/l, measured pre or post-operative

You may not qualify if:

• Regarding history of oncological treatment
• Previous pelvic radiation therapy
• Patients on Androgen Deprivation Therapy (ADT)
• Patients with diseases that affect the red blood cells (e.g., sickle cell anaemia), blood cancer (leukaemia) or bone marrow tumors Regarding history of cardiovascular diseases
• Patients with heart failure New York Heart Association (NYHA) ≥ class 3
• Patients with increased susceptibility to vasodilators include those with left ventricular outflow obstruction (e.g., aortic stenosis, hypertrophic obstructive cardiomyopathy), or those with the rare syndrome of multiple system atrophy manifesting as severely impaired autonomic control of blood pressure.
• Patients with unstable angina pectoris
• Patients using nitride oxide for coronary artery disease
• Patients with hypotension (blood pressure \<90/50 mmHg)
• Patients with recent history of stroke or myocardial infarction
• Patients with diseases that affect blood clotting or causes bleeding (i.e. coagulation disorders) or prolonged erections
• Patients with neurological diseases; such as transient ischemic attack (TIA), Cerebrovascular accident(CVA), Parkinson, and polyneuropathy.
• Allergy regarding Sildenafil
• Patients who have loss of vision in one eye because of non-arteritic anterior ischaemic optic neuropathy (NAION), regardless of whether this episode was in connection or not with previous PDE5 inhibitor exposure.
• Patients with severe hepatic impairment

Sponsors & Collaborators

• The Netherlands Cancer Institute: lead
• Antoni van Leeuwenhoek Hospital: collaborator
• Viatris Inc.: collaborator
• Memidis Pharma: collaborator

Study Sites (3)

Canisius Wilhelmina Ziekenhuis

Nijmegen, Gelderland, 6532SZ, Netherlands

NOT YET RECRUITING

Antoni van Leeuwenhoek hospital, Netherlands Cancer Institute

Amsterdam, North Holland, 1066CX, Netherlands

RECRUITING

Maasstad ziekenhuis

Rotterdam, South Holland, 3079DZ, Netherlands

NOT YET RECRUITING

MeSH Terms

Interventions

Sildenafil Citrate

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Inge Cox, MD

  NCI-Antoni van Leeuwenhoek hospital

  STUDY DIRECTOR

• Melianthe Nicolai, MD/PhD

  NCI-Antoni van Leeuwenhoek hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Inge Cox, MD

CONTACT

020 - 512 9111; i.cox@nki.nl

Melianthe Nicolai, MD/PhD

CONTACT

020 - 512 9111; m.nicolai@nki.nl

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2024
• First Posted: March 13, 2025
• Study Start: January 15, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: March 13, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

NL (3)