Phase 4 Prostate Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People aged between 18 and 70 years old
• People who have a naturally developed penis, with no prior surgical changes to it
• People who have been diagnosed with prostate cancer confirmed by a laboratory tissue test
• People who are scheduled to have their prostate surgically removed (prostatectomy) as their main treatment, with the plan to spare at least one of the nerve bundles involved in erections
• People whose cancer has not spread to lymph nodes or other parts of the body
• People who were able to get erections sufficient for sexual intercourse before their diagnosis
• People who are motivated to take part in a penile rehabilitation program
• People whose surgery resulted in at least partial nerve-sparing (one side), or a nerve-preservation score of 5 or higher (confirm with trial site)
• People whose erection function score before diagnosis met a specific threshold on a standard questionnaire — either an IIEF-EF score of 22 or above (with or without medication), or, for those without a partner or who did not engage in penetrative sex, a specific combined score on a different questionnaire (confirm with trial site)
• People who are willing to provide a blood sample to check testosterone, blood sugar, liver, and cholesterol levels
• People with a testosterone level of at least 12 nmol/l, measured either before or after surgery
• People who have signed a consent form agreeing to take part
• People who can speak and read Dutch

Who may not be able to join:

• People who have previously had radiation therapy to the pelvis
• People currently receiving hormone therapy to reduce testosterone (androgen deprivation therapy)
• People with conditions affecting red blood cells (such as sickle cell anaemia), blood cancers (such as leukaemia), or bone marrow tumours
• People with moderate to severe heart failure (classified as New York Heart Association Class 3 or above)
• People with certain heart or blood vessel conditions that make them sensitive to medications that widen blood vessels, such as aortic stenosis, a specific type of heart muscle thickening, or a rare nervous system disorder affecting blood pressure control
• People with unstable chest pain (unstable angina)
• People using nitric oxide-based medications for heart or artery disease
• People with low blood pressure (below 90/50 mmHg)
• People who have recently had a stroke or heart attack
• People with conditions that affect blood clotting or that can cause prolonged erections
• People with neurological conditions such as mini-strokes (TIA), stroke (CVA), Parkinson's disease, or nerve damage affecting multiple areas of the body (polyneuropathy)
• People with a known allergy to sildenafil (the medication being used in this trial)
• People who have lost vision in one eye due to a specific type of optic nerve condition (non-arteritic anterior ischaemic optic neuropathy / NAION)
• People with severe liver disease
• People with known inherited eye conditions causing gradual vision loss, such as retinitis pigmentosa
• People currently using a class of blood pressure medications called alpha-blockers (though discontinuing these medications may change eligibility — confirm with trial site)
• People who cannot speak or read Dutch
• People whose cancer was found to have spread beyond the prostate to the seminal vesicles or nearby tissue (staged above pT3b) after surgery
• People who need additional radiation therapy or hormone therapy after surgery
• People who are unable to use a vacuum erection device, for example due to severe penile deformity

Important: Always verify eligibility with the trial site directly before applying.