Phase 3 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:

• A tissue sample (biopsy) has confirmed a specific type of prostate cancer called acinar adenocarcinoma, and at least 10 biopsy samples were taken
• An MRI scan of the prostate has been done to assess the local spread of the cancer
• The cancer falls into the "intermediate unfavorable" risk category based on standard medical classification systems, which may include a Grade Group of 3, two or three specific risk factors, or cancer found in 50% or more of the biopsy samples
• The cancer falls into a specific "high risk" subgroup, which may include a Grade Group of 4 (certain Gleason score combinations), a stage of cT3a, or a PSA level above 20 ng/ml
• The person has a general health and activity level rated as 0, 1, or 2 on a standard medical scale (meaning able to carry out daily activities, possibly with some limitations)
• The person is able to understand and sign a written consent form
• The person is willing and able to complete health questionnaires at scheduled times throughout the study
• Urinary symptom score (IPSS) is between 0 and 15, indicating mild to moderate urinary symptoms at most
• The prostate gland is smaller than 100cc in volume
• A PSA blood test has been done within the 60 days before joining the trial
• Imaging scans (PET scan or CT scan with bone scan) show no cancer spread to lymph nodes or other parts of the body
• Information about contraceptive measures has been provided if the person has a partner who could become pregnant

Who may not be able to join:

• A history of another cancer in the past 2 years (skin cancers that are not melanoma are generally excluded from this rule, but all other prior cancers must have been clear of disease for at least 24 months before enrolment)
• Previous surgery on the prostate, other than a specific procedure called TURP (which is only acceptable if it was done at least 6 weeks before treatment begins)
• Previous radiation therapy to the pelvic area
• Previous use of hormone therapy to reduce male hormones (androgen deprivation therapy), not counting a specific class of medications called 5-alpha reductase inhibitors
• Any previous active treatment for prostate cancer (people previously on active surveillance monitoring may still be considered if other criteria are met)
• Active severe inflammatory bowel disease
• Bilateral hip replacements, or any implant that could significantly interfere with radiation dose planning calculations
• Age over 80 years
• Cancer that has reached certain more advanced local stages (cT4a, cT3b) or has spread to pelvic lymph nodes
• A known allergy or medical reason that prevents use of a hormone medication called Triptoreline
• Use of 5-alpha reductase inhibitor medications that have not been stopped at least 4 weeks before joining the trial
• A history of bone fractures or falls
• Known risk factors for abnormal heart rhythms or a heart condition called QT prolongation
• Current use of medications known to affect heart rhythm (QT/QTc interval prolongation)

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