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 @ 12:36 PM
Ignite Modification Date:
2025-12-24 @ 12:36 PM
NCT ID:
NCT04284761
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed adenocarcinoma of the prostate.
* Study participant qualified and planning for radical prostatectomy.
* At least 1 prostate lesion measurable by MRI \> 0.5 cm within one month of screening.
* PSA \> 3 ng/mL within 3 months of screening.
* Gleason score 3+4 or higher.
* Study participant must be willing to undergo post-treatment imaging by MRI.
* ECOG performance status 0 or 1.
Exclusion Criteria:
* Prior radiotherapy or surgery for prostate cancer.
* Prior or ongoing hormonal therapy for prostate cancer.
* Prior prostate procedures such as transurethral resection of the prostate, transurethral microwave thermotherapy of the prostate, high-intensity focused ultrasound or minimally invasive BPH procedure.
* Study participant unwilling or unable to undergo MRI, including patients with contra-indications to MRI, such as cardiac pacemakers, non-compatible intracranial vascular clips, etc.
* Metallic hip implant or any other metallic implant or device that distorts the quality of prostatic MR images.
* Use of 5 alpha reductase inhibitors (e.g. Finasteride or Dutasteride) within 3 months of screening or total use within the last two years prior to screening of \> 3 months.
* Presence of any metastatic disease.
* Prostate volume more than 80 cc at prior MRI imaging.
* I-PSS score \>20.
* History of prostate infection.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
35 Years
Study:
NCT04284761
Study Brief:
Protocol Section:
NCT04284761