Prostate Cancer Clinical Trial
A Pilot Study of 5-AZA and ATRA for Prostate Cancer With PSA-only Recurrence After Local Treatment
Summary
This is a prospective, open-label, randomized, cross-over, pilot study of reprogramming therapy in patients with recurrent PCa based on rising PSA only. The primary objectives are to compare the disease progression-free rate at the end of 12 weeks between 5-AZA+ATRA and no therapy and to assess safety of the 5-AZA and ATRA combination. All study enrollees will receive Lupron. After one month, they will be assigned in a 1:1 randomization to either the '5-AZA+ATRA' group or the 'no therapy' group. Patients in the '5-AZA + ATRA' group will receive treatment on a 28-day cycle, in the absence of prohibitive toxicities, for 3 cycles. Patients will initially be observed for 3 cycles under either no therapy or combination therapy, before crossing over to receive the opposite treatment for another 3 cycles in the absence of prohibitive toxicities. After the treatment period, all patients will be followed for a total of 24 months from the start of the study or until the events leading to discontinuation are observed.
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There is 1 Location for this study
New York New York, 10029, United States
How clear is this clinincal trial information?
Please confirm you are a US based health care provider:
Yes, I am a health care Provider No, I am not a health care providerSign Up Now.
Take Control of Your Disease Journey.
Sign up now for expert patient guides, personalized treatment options, and cutting-edge insights that can help you push for the best care plan.