Authorised Therapeutic use (Phase IV) Prostate cancer

PEHAB II

EU CTIS ID: 2023-507466-40-00

What this study is testing

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.

  • Therapeutic use (Phase IV)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • Pre-screening eligibility criteria: Age > 18 years and < 75 years
  • Pre-screening eligibility criteria: Motivated to participate in a penile rehabilitation program
  • Inclusion criteria: All of the above-mentioned pre-screening eligibility criteria
  • Inclusion criteria: At least unilateral nerve-sparing or if available FP score =>5
  • Inclusion criteria: A pre-diagnostic anamnestic erection that was good enough for intercourse.
  • Pre-screening eligibility criteria: Patients who have a penis that has developed naturally, without surgical interventions.

You likely can't join if

  • Exclusion criteria: Adjuvant radiotherapy or hormonal therapy
  • Exclusion criteria: Inability to use VED such as severe penile deformity or too much peripubic, or belly fat causing fitting problems
  • Exclusion criteria: All of the above-mentioned pre-screening exclusion criteria
  • Pre-screening exclusion criteria: 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
  • Pre-screening exclusion criteria: 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 (within the last 6 months) history of stroke (CVA or TIA) or myocardial infarction  Patients with diseases that affect blood clotting or causes bleeding (i.e. coagulation disorders) or prolonged erections  Patients with a severe renal impairment (creatinine clearance <30 mL/min)  Patients with hepatic impairment (cirrhosis)
  • Pre-screening exclusion criteria: Other pre-screening exclusion criteria:  Patients with other neurological diseases; such as 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  Patients with known hereditary degenerative retinal disorders such as retinitis pigmentosa (a minority of these patients have genetic disorders of retinal phosphodiesterases).  Patients using alpha-blockers, but they may be eligible to participate after discontinuing alpha-blocker use.  The inability to speak and read in Dutch
See the full eligibility criteria
Who can join
  • Pre-screening eligibility criteria: Age > 18 years and < 75 years
  • Pre-screening eligibility criteria: Motivated to participate in a penile rehabilitation program
  • Inclusion criteria: All of the above-mentioned pre-screening eligibility criteria
  • Inclusion criteria: At least unilateral nerve-sparing or if available FP score =>5
  • Inclusion criteria: A pre-diagnostic anamnestic erection that was good enough for intercourse.
  • Pre-screening eligibility criteria: Patients who have a penis that has developed naturally, without surgical interventions.
  • Inclusion criteria: 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.
  • Inclusion criteria: Willing to provide blood samples to determine testosterone level, Hb1Ac, liver enzymes and lipid profile
  • Inclusion criteria: Testosterone levels of at least >9 nmol/l, measured pre or post-operative. Blood needs to be obtained before 11 am and before breakfast with the absence of hypo gonadal symptoms such as loss of libido, lack of energy and orgasmic dysfunction
  • Inclusion criteria: A signed informed consent form
  • Pre-screening eligibility criteria: Histologically confirmed PCa
  • Pre-screening eligibility criteria: Scheduled for RP as primary treatment with the intention of at least a one-sided nerve-sparing procedure.
  • Pre-screening eligibility criteria: Non-metastatic disease (cN0M0)
  • Pre-screening eligibility criteria: Pre-operative erections good enough for intercourse (anamnestic)
What rules you out
  • Exclusion criteria: Adjuvant radiotherapy or hormonal therapy
  • Exclusion criteria: Inability to use VED such as severe penile deformity or too much peripubic, or belly fat causing fitting problems
  • Exclusion criteria: All of the above-mentioned pre-screening exclusion criteria
  • Pre-screening exclusion criteria: 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
  • Pre-screening exclusion criteria: 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 (within the last 6 months) history of stroke (CVA or TIA) or myocardial infarction  Patients with diseases that affect blood clotting or causes bleeding (i.e. coagulation disorders) or prolonged erections  Patients with a severe renal impairment (creatinine clearance <30 mL/min)  Patients with hepatic impairment (cirrhosis)
  • Pre-screening exclusion criteria: Other pre-screening exclusion criteria:  Patients with other neurological diseases; such as 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  Patients with known hereditary degenerative retinal disorders such as retinitis pigmentosa (a minority of these patients have genetic disorders of retinal phosphodiesterases).  Patients using alpha-blockers, but they may be eligible to participate after discontinuing alpha-blocker use.  The inability to speak and read in Dutch

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.