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 @ 5:01 PM
Ignite Modification Date:
2025-12-24 @ 5:01 PM
NCT ID:
NCT02048150
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed adenocarcinoma of the prostate; patients with small cell, neuroendocrine, and transitional cell carcinomas are not eligible
* Patients being considered for RALP and pelvic lymphadenectomy with life expectancy greater than 10 years as determined by treating physician
* Patients with moderate to high-risk disease as defined by D' Amico risk stratification and having at least one of the following:
* Prostate-specific antigen (PSA) level \> 10 ng/ml
* Gleason score \>= 7
* Clinical stage \>= T2c
* Any performance status on the Eastern Cooperative Oncology Group (ECOG)
* Men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following duration of study participation
* Bone scan without evidence of skeletal metastases
* Skeletal x-ray film or MRI confirmation of absent skeletal metastases if bone scan findings are equivocal
* 3Tesla (T) multiparametric MRI of the prostate performed at City of Hope (COH) within 6 week time period prior to surgery; MRI without evidence of bladder neck involvement, rectal wall involvement, or pelvic lymphadenopathy with no nodes \> 1 cm
* White blood cell (WBC) within normal limits
* Hemoglobin (hgb) \> 10 G/dL
* Platelet count (PLT) \> 100 K/uL
* Creatinine clearance within normal limits
* Serum glutamic oxaloacetic transaminase (SGOT) \< 1.5 x upper limit of normal (ULN)
* Serum glutamate pyruvate transaminase (SGPT) \< 1.5 x ULN
* Bilirubin \< 1.5 x ULN
* All subjects must have the ability to understand and the willingness to sign a written informed consent
Exclusion Criteria:
* Patients should not have any uncontrolled illness including ongoing or active infection
* Prior treatment of prostate cancer including brachytherapy, radiation therapy, cryosurgery, high-intensity focused ultrasound (HIFU), or vaccine therapy
* Prior pelvic surgery or radiation
* Urinary incontinence requiring condom catheter use or \>= 1 pad/day
* Prior anti-incontinence surgery
* Use of neoadjuvant hormonal manipulation
* History of active co-existing non-prostatic malignancies except basal cell skin cancer or squamous cell skin cancer
* Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
36 Years
Maximum Age:
74 Years
Study:
NCT02048150
Study Brief:
Protocol Section:
NCT02048150