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NCT Number: NCT03572387

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

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.

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Key information

Conditions

Prostatic Neoplasms Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostate Cancer Prostate Neoplasms Prostatic Diseases Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Icahn School of Medicine at Mount Sinai

New York, 10029, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

5-Azacitidine

Drug

subcutaneously on days 1-5 at a dose of 40 mg/m^2

Other names: 5-AZA

all trans Retinoic Acid

Drug

45 mg/m^2, will be taken orally on days 3-7 of each cycle, divided into two doses

Other names: ATRA

Lupron

Drug

7.5 mg x 1

Other names: Leuprolide

Primary outcomes

  1. Number of Participants With PSA Response

    Time frame: baseline and 24 weeks

    Number of participants with PSA response, as defined by PSA decreased > 30% as compared from baseline.

Secondary outcomes

  1. Percentage of Patients With Prolongation of PSA Doubling Time (PSADT) Post-treatment

    Time frame: baseline and 24 weeks

    Percentage of patients with prolongation of PSA doubling time (PSADT) post-treatment compared to baseline after treatment with 3 cycles of Aza and ATRA.

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Jun 28, 2018
Registry last updated
Apr 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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