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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Summary
This is a multicenter, randomized, phase II study of the safety and efficacy of two dose levels of oral ATN-224 in patients with prostate cancer with a rising serum PSA in the absence of detectable disease. Patients will be randomized (1:1) after confirmation of eligibility requirements. The primary endpoint is to determine the proportion of patients who do not have PSA progression for 24 weeks. PSA progression is defined as at least a 50% increase in PSA and \>5 ng/mL from baseline or post-treatment nadir if lower than baseline, confirmed by another PSA at least 28 days later.
Eligible Conditions
- Prostate Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Side effects data
From 2013 Phase 2 trial • 69 Patients • NCT0017680078%
Leukopenia
45%
Anemia
43%
Nausea
32%
Vomiting
28%
Neutopenia
28%
Constipation
17%
Thrombocytopenia
10%
Diarrhea
4%
Diarrhea (no colostomy)
3%
Anorexia
3%
Febrile neutropenia
3%
Gastrointestinal-Other
3%
Infection without neutropenia
3%
Thrombotic microangiopathy
1%
Bilirubin
1%
Depressed level of consciousness
1%
Cardiac-ischemia/infarction
1%
Cardiovascular/Arrhythmia-Other
1%
Catheter-related infection
1%
Chest pain (non-cardiac and non-pleuritic)
1%
Dehydration
1%
Dermatology/Skin-Other
1%
Hypotension
1%
Ileus (or neuroconstipation)
1%
Melena/GI bleeding
1%
Operative injury of vein/artery
1%
Pleural effusion (non-malignant)
1%
Pulmonary-Other
1%
Supraventricular arrhythmias
1%
Wound-non-infectious
1%
Hypokalemia
1%
Colitis
1%
Thrombosis/embolism
100%
80%
60%
40%
20%
0%
Study treatment Arm
Chemoradiation and Tetrathiomolybdate (TM)
Trial Design
2Treatment groups
Experimental Treatment
Group I: Low DoseExperimental Treatment1 Intervention
ATN-224 dose: 30mg
Group II: High DoseExperimental Treatment1 Intervention
ATN-224 dose 300mg
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Who is running the clinical trial?
Prostate Cancer Clinical Trials ConsortiumOTHER
10 Previous Clinical Trials
7,188 Total Patients Enrolled
7 Trials studying Prostate Cancer
6,984 Patients Enrolled for Prostate Cancer
AttenuonLead Sponsor
3 Previous Clinical Trials
142 Total Patients Enrolled
Gilad Gordon, MDStudy Director
4 Previous Clinical Trials
261 Total Patients Enrolled
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