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 @ 2:16 AM
Ignite Modification Date:
2025-12-25 @ 2:16 AM
NCT ID:
NCT02693860
Eligibility Criteria:
Inclusion Criteria:
1. Adult male \> 18 years of age
2. Histologically confirmed diagnosis of prostate cancer
3. Intermediate or high risk prostate cancer defined by:
* High risk (any one of the following):
1. Gleason grade \> 8
2. Gleason grade 4+3 with more than 3 cores involved with \> 20% of volume involved
3. Any Gleason with PSA above 20 ng/mL
4. Gleasone \> 4+3 and tumor stage clinical T3 or above
* Intermediate risk prostate cancer defined as:
1. Gleason grade = 7
2. Any Gleason with PSA between 10 and 20 ng/mL
4. Eastern Cooperative Oncology Group (ECOG) Performance status of 0-1
5. Ability to understand and willingness to sign a written informed consent document
6. Prostate biopsy with + PSMA expression in tumor cells by immunohistochemistry
Exclusion Criteria:
1. Serum creatinine \> 3x upper limit of normal (ULN)
2. Bilirubin (total) \> 1.5 x ULN; subjects with Gilbert's syndrome will be allowed if direct bilirubin is within institutional normal limits
3. Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT or SGOT) \> 2.5x ULN
4. Other severe acute or chronic medical condition or laboratory abnormality that may increase the risk associated with study participation
5. On any other new anticancer therapy between screening and prostatectomy
6. Frank metastasis identified during clinical staging
7. Patient ineligible for radical prostatectomy for any other reason
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT02693860
Study Brief:
Protocol Section:
NCT02693860