A Pilot Study of 5-AZA and ATRA for Prostate Cancer With PSA-only Recurrence After Local Treatment

Prostate Cancer Clinical Trial

Official title: A Pilot Study of the Combination of 5-azacitidine (5-AZA) and All-trans Retinoic Acid (ATRA) for Prostate Cancer (PCa) With PSA-only Recurrence After Definitive Local Treatment

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Neoplasms
• Prostate Cancer
• Prostate Neoplasms
• Prostatic Neoplasms
• Recurrence

• NCT number: NCT03572387
• Study type: Interventional
• Source: Icahn School of Medicine at Mount Sinai
• Status: Completed
• Phase: Phase 2
• Start date: August 20, 2018
• Completion date: July 8, 2022