Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:35 PM
Ignite Modification Date:
2025-12-24 @ 3:35 PM
NCT ID:
NCT04430192
Eligibility Criteria:
Inclusion Criteria:
* Patient has provided written informed consent.
* Male patient aged 18 or over at the time of screening
* Histologically confirmed adenocarcinoma of the prostate, in a patient scheduled for RP and PLND with curative intent
* High or high-intermediate risk localised or locoregional prostate cancer (HRCaP) by European Association of Urology (EAU) criteria, including any of the following:
* PSA \> 20 ng/mL
* ISUP grade group 3-5
* Clinical T-stage by digital rectal examination (DRE) of T2c or higher
* N1 disease (involvement of lymph nodes at or below the bifurcation of the common iliac arteries)
* defined radiologically (CT/ MRI, or PSMA PET).
* High PSMA avidity on 68Ga-PSMA PET/CT, defined as an SUVmax of ≥ 20
* Normal baseline haematological function; haemoglobin 13.5-17.5g/dl), total white blood cell count (4-11 x 109/l), platelets (150-400 x 109/l), neutrophils (2-7.5 x 109/l) and lymphocytes (1-4 x 109/l)
* Normal baseline serum biochemistry; sodium 135-145 nmol/l, potassium 3.5-5 nmol/l, chloride 98-108 nmol/l, urea 3-9.2 nmol/l, creatinine 60-120μmol/l
* Willing and able to comply with all study requirements including all treatments and required assessments including follow up
Exclusion Criteria:
* Prostate cancer with significant neuroendocrine or other rare variant pathology
* Prior treatment for prostate cancer including radiotherapy and/or androgen deprivation therapy.
* Evidence of metastatic disease involving bone, viscera, or lymph nodes superior to the common iliac bifurcation based on CT, MRI, WBBS or PSMA PET/CT.
* Renal impairment \[GFR \< 60mL/min\].
* Sjogren's syndrome.
* A history of or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating investigator.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT04430192
Study Brief:
Protocol Section:
NCT04430192