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 @ 4:52 PM
Ignite Modification Date:
2025-12-24 @ 4:52 PM
NCT ID:
NCT02911350
Eligibility Criteria:
Inclusion Criteria:
* Any one or more of the following characteristics will qualify patient with T2/T3 prostate cancer for eligibility to current study:
* Biopsy proven prostate cancer with Gleason score \> 7
* Pathologic staging TXN1 (on MRI or CT)
* Prostate-specific antigen (PSA) \> 10 ng/ml done within a month prior to study entry (the day of first hormonal ablation) and \> 10 days after prostate biopsy.
In addition patients must also have:
* Performance status \< 2
* Hemoglobin \> 11 grams per deciliter (g/dL), White blood cell (WBC) \> 4000 and platelet count \> 100.000/l
* No evidence of other synchronous primary. Prior malignancies does not exclude if the patient is disease free \> 5 years.
* Prior or concurrent basal cell or non-invasive squamous carcinoma of the skin is eligible and
* Received hormone therapy with any of the following combination for less than 3 months
* Lupron / Flutamide
* Zoladex/ Flutamide
* Lupron/ Casodex
* Zoladex/ Casodex
Exclusion Criteria:
* Clinical stage T1N0, PSA \< 10, and Gleason score less than 7.
* Evidence of distant metastasis
* Previous surgery for prostate cancer (radical prostatectomy).
* Current treatment with ketoconazole, cimetidine or hormone therapy for more than 3 months prior to inclusion in the protocol for prostate cancer
* Major medical or psychiatric illness, which in the investigator's opinion may prevent completion of the study and interfere with follow up.
* Bilirubin \> 1.5
* Prior chemotherapy is not allowed
Healthy Volunteers:
False
Sex:
MALE
Study:
NCT02911350
Study Brief:
Protocol Section:
NCT02911350