NCT03572387

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

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Icahn School of Medicine at Mount Sinai · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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 of treatment 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. In the 'no therapy' group, patients will initially be observed for 3 cycles and then receive treatment for 3 cycles, in the absence of prohibitive toxicities. After the treatment period, all patients will be followed for up to 24 months from the start of the study or until the events leading to discontinuation are observed.

Conditions

• Prostatic Neoplasms
• Prostate Neoplasms
• Prostate Cancer

Interventions

Type	Name	Description
DRUG	5-Azacitidine	subcutaneously on days 1-5 at a dose of 40 mg/m\^2
DRUG	all trans retinoic acid	45 mg/m\^2, will be taken orally on days 3-7 of each cycle, divided into two doses
DRUG	Lupron	7.5 mg x 1

Timeline

• Start date: 2018-08-20
• Primary completion: 2022-06-19
• Completion: 2022-07-08
• First posted: 2018-06-28
• Last updated: 2024-04-30
• Results posted: 2024-04-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study