A Pilot Study of 5-AZA and ATRA for Prostate Cancer With PSA-only Recurrence After Local Treatment
Status:
Recruiting
Trial end date:
2022-08-01
Target enrollment:
Participant gender:
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.