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 @ 2:39 AM
Ignite Modification Date:
2025-12-25 @ 2:39 AM
NCT ID:
NCT01709734
Eligibility Criteria:
Inclusion Criteria:
1. Histologically or cytologically confirmed adenocarcinoma of the prostate
2. Ongoing androgen blockade demonstrated by serum testosterone concentration of less than 50 ng/dL
3. Demonstration of progression while on androgen blockade
4. Eastern Cooperative Oncology Group (ECOG) Performance Status \<2
Exclusion Criteria:
1. Depending upon patient prior treatment the following apply:
* Prior treatment with CYP17 inhibitors or AR antagonists (e.g. abiraterone, TAK-700, ARN-509, ketoconazole\*, enzalutamide, or galeterone) - Treatment naïve only
* Prior treatment with CYP17 inhibitors (e.g. TAK-700, ketoconazole\*) or AR antagonists (e.g. enzalutamide, ARN-509,) or galeterone - abiraterone refractory only
* Prior treatment with CYP17 inhibitors (e.g. abiraterone, TAK-700, ketoconazole\*) or AR antagonists (e.g. ARN -509) or galeterone - enzalutamide refractory only
2. Prior chemotherapy (unless allowed for some study arms)
3. Treatment with non-steroidal oral antiandrogens within 4 weeks of enrollment
4. Prior use of any chronic systemic glucocorticoids .
5. Prior radiation therapy within 3 weeks and radionuclide therapy within 8 weeks of enrollment
6. Prior treatment with Alpharadin® (Xofigo®)
7. Treatment with anti arrhythmia therapy for ventricular arrhythmia \< 4 weeks prior to enrollment
8. Treatment with Coumadin® or other anti-coagulant therapy (except aspirin) \< 4 weeks prior to enrollment
9. Severe systemic diseases or active uncontrolled illnesses.
10. Abnormal heart function
11. Liver metastases
12. Brain metastases (unless stable disease \>3 mos. by scan without additional CNS-directed therapy)
13. The patient has known allergy to any of the treatment components
14. Any physical or mental condition or social situation that in the opinion of the Investigator may interfere with the patient's ability to comply with the trial procedures
15. History of excessive alcohol consumption
16. Use of any substance known to cause AME
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT01709734
Study Brief:
Protocol Section:
NCT01709734