Phase 2 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:

• Men between the ages of 40 and 65 years
• Men who identify as exclusively heterosexual, regardless of race or social background
• Men who had their prostate removed (radical prostatectomy, or RP) as treatment for prostate cancer that had not spread to other parts of the body
• Men whose prostate removal surgery took place less than 60 days before the screening visit
• Men who had normal erectile function before surgery, based on a specific questionnaire score (IIEF domain A score above 22)
• Men who have had a stable sexual partner for more than 2 months before the surgery, and who plan to remain in that relationship during the study
• Men who have been taking 5mg Tadalafil (a medication for erectile dysfunction) continuously from day 30 up to day 60 after their surgery

Who may not be able to join:

• People whose prostate cancer was classified as an advanced local stage (T3 or T4 in the TNM staging system — confirm with trial site)
• People who had a type of prostate removal surgery done through the perineal area or as an open (non-keyhole) procedure
• People who need additional treatments for their prostate cancer beyond surgery, such as radiation therapy or hormone therapy
• People with poorly controlled diabetes at the time of the screening visit (based on a blood test result above a certain level — confirm with trial site)
• People with a previous spinal cord injury that caused paralysis of the lower limbs
• People currently using male hormone treatments, or people with low hormone levels (hypogonadism) based on blood test results
• People currently experiencing depression, including those who are using or who need to use antidepressant medication
• People with significant physical conditions affecting the genitals, such as severe penile scarring or Peyronie's disease, or an active sexually transmitted infection (such as herpes, gonorrhoea, HPV, or similar)
• People using topical (applied to the skin) medications in the genital area that could interfere with the study treatment
• People who already have a penile prosthesis (implant)
• People with a history of low blood pressure causing symptoms, or conditions that increase this risk, such as heart disease (including angina or heart failure) or kidney disease
• People currently taking nitrate medications (such as certain heart medications including isosorbide or nitroglycerin), or the medications ketoconazole, ritonavir, or rifampicin
• People whose ECG (heart tracing) or blood test results are considered by the study doctor to pose a risk or interfere with the study
• People whose blood pressure falls outside safe limits set by the study (confirm exact values with trial site)
• People with conditions known to cause prolonged unwanted erections (priapism), such as sickle cell anaemia, multiple myeloma, or leukaemia
• People with a history of priapism (a painful erection lasting up to 6 hours or more)
• People currently experiencing ongoing diarrhoea lasting more than four weeks, especially if accompanied by abdominal pain, difficulty absorbing nutrients, or blood, pus, or mucus in the stool
• People with a known allergy or sensitivity to tadalafil or the study drug BZ371A
• People with a history of symptomatic lactose intolerance, such as needing enzyme treatment or experiencing bloating or diarrhoea after consuming lactose-containing products
• People who took less than 80% of their prescribed 5mg Tadalafil doses between day 30 and day 60 after surgery
• People whose partner is pregnant or breastfeeding
• People whose partner is of childbearing age and does not agree to be exposed to the study treatment (confirm with trial site)
• People with any other serious illness, condition, or physical finding — including cancers other than prostate cancer, severe mental illness, or ongoing substance misuse — that the study doctor considers a risk or likely to affect study results

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