Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Icahn School of Medicine at Mount Sinai
Age
18–any
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
Histologically confirmed adenocarcinoma of the prostate
Rising PSA
PSADT ≤ 10 months prior to initiation of ADT
No evidence of regional or active distant metastases, except for regional metastasis where salvage radiation therapy is not an option
Indication for ADT after receiving definitive local therapy
Males ≥ 18 years.
ECOG performance status of ≤ 2
Men must agree to use a condom and not father a child or donate sperm for the duration of the study and for 90 days after completion of therapy
Ability to understand and the willingness to sign a written informed consent
Ability to adhere to the study visit schedule and requirements of the protocol
You may not be if
Patients who have received ADT and/or other chemotherapy within 3 months prior to entering the study.
Patients who have had radiotherapy or surgery within 4 weeks prior to entering the study. Minimally-invasive procedures for the purpose of diagnosis or staging of the disease are permitted.
Patients may not be receiving any other investigational agents.
Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
History of allergic reactions attributed to compounds of similar chemical or biologic composition to 5-AZA and ATRA.
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Significant active cardiac disease within the previous 6 months
Inadequate organ and marrow function as defined below:
leukocytes ≤ 3,000/mcL
absolute neutrophil count ≤ 1,500/mcL
platelets ≤ 100,000/mcl
total bilirubin above normal institutional limits
AST(SGOT)/ALT(SPGT) ≥ 2.5 X institutional upper limit of normal
creatinine above normal institutional limits
Clareo Health | A Pilot Study of 5-AZA and ATRA for Prostate Cancer With PSA-only Recurrence After Local Treatment
