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Antioxidant

High Dose for Prostate Cancer

Phase 2
Waitlist Available
Research Sponsored by Attenuon
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 24 weeks
Awards & highlights

Study 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 weeks
Treatment ~ Varies
Follow Up ~end of study
This trial's timeline: 3 weeks for screening, Varies for treatment, and end of study for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Determine the proportion of patients who have not had prostate specific antigen (PSA) progression for 24 weeks
Secondary outcome measures
Determine the 24-week rate of metastases
Determine the change in PSA doubling time (PSA-DT) from baseline
Determine the effect of ATN-224 treatment on levels of Cu,Zn-superoxide dismutase (SOD1) in red blood cells
+4 more

Side effects data

From 2013 Phase 2 trial • 69 Patients • NCT00176800
78%
Leukopenia
45%
Anemia
43%
Nausea
32%
Vomiting
28%
Neutopenia
28%
Constipation
17%
Thrombocytopenia
10%
Diarrhea
4%
Diarrhea (no colostomy)
3%
Febrile neutropenia
3%
Anorexia
3%
Gastrointestinal-Other
3%
Infection without neutropenia
3%
Thrombotic microangiopathy
1%
Supraventricular arrhythmias
1%
Pleural effusion (non-malignant)
1%
Catheter-related infection
1%
Ileus (or neuroconstipation)
1%
Bilirubin
1%
Cardiac-ischemia/infarction
1%
Dehydration
1%
Cardiovascular/Arrhythmia-Other
1%
Wound-non-infectious
1%
Chest pain (non-cardiac and non-pleuritic)
1%
Depressed level of consciousness
1%
Melena/GI bleeding
1%
Dermatology/Skin-Other
1%
Hypotension
1%
Operative injury of vein/artery
1%
Pulmonary-Other
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

Find a Location

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Study of ATN-224 in Patients With Prostate Cancer
2006. "Study of ATN-224 in Patients With Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00405574.
All > Prostate
~3 spots leftby Apr 2025
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