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 @ 1:13 PM
Ignite Modification Date:
2025-12-24 @ 1:13 PM
NCT ID:
NCT00448695
Eligibility Criteria:
Inclusion Criteria:
* Men \> 18 years of age;
* Histologically-proven prostate carcinoma;
* Prostate cancer clinical stage T1c
* Only one sector of the prostate demonstrating prostate cancer with no more than 1 core positive
* Gleason score \<7 ;
* Each core must range between of 10 to 50% adenocarcinoma.
* Prostate MRI must confirm area suspicious for cancer in the sector of the positive biopsy;
* A minimum of six (6) weeks between the prostate biopsy and the Inclusion Visit;
* Prostate specific antigen (PSA) level £ 10 ng/mL
* PORPUS, IPSS, and IIEF complete prior to procedure
* Prostate volume \< 60 cc as measured by ultra sound;
* Uroflow \>12 cc/sec with post void residual \< 100 cc.
* Life expectancy of greater than 5 years, based on co-morbidity not related to prostate cancer.
Exclusion Criteria:Patients with any of the following exclusion criteria will be excluded from study participation:
* Patients who are unwilling or unable to give informed consent;
* Patients with foci location in the Apex of the prostate or isolated transition zone cancers
* Patients who have received androgen suppression therapy
* Patients who have received or are receiving chemotherapy for prostate carcinoma;
* Patients previously treated with surgery to the prostate (traditional, endoscopic or minimally invasive including HIFU, TUNA, RITA, microwave, TURP ,cryotherapy or any curative treatment
* Patients whose has undergone radiation therapy for prostate cancer
* Any condition, or history of illness or surgery that, in the opinion of the Investigator , might confound the results of the study or pose additional risks to the patient (e.g. significant cardiovascular conditions or allergies);
* Patients with a history of non compliance with medical therapy and/or medical recommendations;
* Patients who are unwilling or unable to complete the patient self-assessment questionnaires;
* Myocardial infarction, transient ischemic attack or stroke, within 6 months prior to the study, Unstable or uncontrolled angina, uncontrolled heart failure, or serious uncontrolled ventricular arrhythmias
* Chronic or acute prostititis, neuroginic bladder, urinary tract infection, sphincter abnormalities, or any other symptom that prevents normal micturition.
* Patients who have participated in a clinical study and/or received treatment with an investigational treatment and/or product within the past 90 days;
* All medications that cause a decrease clotting, vasoconstriction or platelet aggregation, must be stopped prior to treatment.
* History of Colon Cancer or Colon Surgery preformed
* If the patient is unable to undergo anesthesia
* Patients with contraindication to MRI (i.e. pacemaker, hip prosthesis, severe claustrophobia, brain aneurysm clip, allergy to MRI contrast agent).
* Any condition, or history of illness that, in the opinion of the investigator will confound or increase the patient risk during the study
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT00448695
Study Brief:
Protocol Section:
NCT00448695