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 @ 4:38 AM
Ignite Modification Date:
2025-12-25 @ 4:38 AM
NCT ID:
NCT01229618
Eligibility Criteria:
INCLUSION CRITERIA:
1. The subject has biopsy-proven prostate cancer and is either undergoing active surveillance ("watchful waiting") or pre primary local treatment for prostate cancer (i.e., prior to either radiation therapy or radical prostatectomy).
2. The subject is able and willing to comply with study procedures and provide signed and dated informed consent.
3. The subject has concordant MRI/1H MRSI findings from a prior MR staging exam performed within 8 weeks of the 13C MRSI exam performed in this study with IMP, or is willing to undergo MRI/1H MRSI in connection with the study exam.
4. Negative test for hepatitis B and hepatitis C.
5. Eastern Cooperative Oncology Group Performance Status of 0 or 1.
6. Laboratory criteria for protocol entry:
* Absolute neutrophil count (ANC) \>/= 1500 cells/microLiters
* Hemoglobin \>/= 9.0 gm/dL
* Platelets \>/= 100,000 cells/microLiters
* Estimated creatinine clearance \>/= 60 mL/min (by the Cockcroft Gault equation)
* Bilirubin within normal range
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) within normal range
7. Willing to use contraception during and for 1 month after completion of the study.
EXCLUSION CRITERIA:
1. The subject has received, or is scheduled to receive, another IMP from 1 month before to 1 month after inclusion in this study.
2. Current or prior androgen deprivation therapy; previous use of a 5-alpha reductase inhibitor is allowed, provided it was discontinued at least 1 month prior to study entry.
3. Poorly controlled hypertension, with blood pressure at study entry \>150/90.
4. Contraindication for or inability to tolerate MRI examination.
5. Prostate biopsy within 12 weeks prior to study entry.
6. BMI of less than 18.5 or greater than 32. At the 0.43 ml/kg dose, subject body weight should be less than or equal to 100 kg owing to limitations in the amount of IMP available.
7. Congestive heart failure or New York Heart Association (NYHA) status \>2.
8. A past or present medical history of clinically significant electrocardiogram (EKG) abnormalities, including QT prolongation, a family history of prolonged QT interval syndrome, or myocardial infarction (MI) less than 1 year ago with ensuing unstable EKG.
9. Ongoing acute or chronic pulmonary bronchospastic disease, including a history of chronic obstructive pulmonary disease or asthma, with an exacerbation within the past year.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT01229618
Study Brief:
Protocol Section:
NCT01229618