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:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2025-12-25 @ 12:45 AM
NCT ID:
NCT06054867
Eligibility Criteria:
Inclusion Criteria:
* Clinical Stage ≤ T2c
* PSA ≤ 20 ng/ml
* Prostate volume ≥ 30 ml
* Grade Group (GG) 1 or 2: If GG 1: ≥ 3 cores positive for cancer. Note, multiple positive from any MRI targeted lesion will be considered as a single positive core.
Exclusion Criteria:
* Any prior or current treatment for prostate cancer, including but not limited to surgery, radiation therapy (external or brachytherapy), tissue ablation or chemotherapy.
* Patients with previous surgical or minimally invasive treatment of benign prostatic hyperplasia within the prior 12 months.
* Radiographically suspicious lymph node involvement confirmed with biopsy or PET scan.
* Evidence of bone metastasis.
* Evidence of extracapsular involvement.
* Evidence of seminal vesicle invasion on DRE or MRI read as "definite", "probable" or "consistent with"
* Any condition or history of illness or surgery that may pose an additional risk to men undergoing the Aquablation procedure.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
40 Years
Study:
NCT06054867
Study Brief:
Protocol Section:
NCT06054867