Trial · Interventional

CompletedPhase 2Results postedRegistry data

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

NCTNCT03572387Other idGCO 16-0752

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 2
Enrollment: 14 participants (actual)
Sponsor: Icahn School of Medicine at Mount Sinai · Other
Design: Randomized · Open label (no masking)
Countries: 1 country
United States
Start: 20 Aug 2018
Primary completion: 19 Jun 2022
Completion: 8 Jul 2022
First posted: 28 Jun 2018
Last update posted: 30 Apr 2024
Conditions: Prostatic Neoplasms · Prostate Neoplasms · Prostate Cancer

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

201820192020202120222023

Ph 2
A Pilot Study of 5-AZA and ATRA for Prostate Cancer With PSA-only Recurrence After Local Treatment
NCT03572387
20 Aug 2018 to 8 Jul 2022

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

5-AzacitidineDrug
all trans retinoic acidDrug
LupronDrug

Arms2

Experimental
5-AZA + ATRA ('early' 5-AZA+ATRA)
Combination of 5-Azacitidine (5-AZA) + all trans retinoic acid (ATRA) group after one month of Lupron, group will receive treatment on a 28-day cycle, in the absence of prohibitive toxicities, for 3 cycles.
Active comparator
No therapy ('delayed' 5-AZA+ATRA)
After one month of lupron, patients will receive no therapy for 3 cycles (12 weeks). After this observation period, patients will receive combination of 5-Azacitidine (5-AZA) + all trans retinoic acid (ATRA) group on a 28-day cycle, in the absence of prohibitive toxicities, for 3 cycles.

Primary outcomes1

Outcomes the sponsor listed as primary.

Number of Participants With PSA Response
Time frame · baseline and 24 weeks
Registry description
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
Registry description
Percentage of patients with prolongation of PSA doubling time (PSADT) post-treatment compared to baseline after treatment with 3 cycles of Aza and ATRA.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeCount of participants· baseline and 24 weeks

Number of Participants With PSA Response

Group	Value (Participants)
'Early' 5-AZA+ATRA	0
'Delayed' 5-AZA+ATRA	0

Secondary and other outcome results(1)

Secondary outcomeNumber· baseline and 24 weeks

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

Group	Value (percentage of participants)
'Early' 5-AZA+ATRA	33.3
'Delayed' 5-AZA+ATRA	25

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
'Early' 5-AZA+ATRAPatients will receive Lupron 7.5 mg x 1. Four weeks later, they will receive 5-AZA+ATRA treatment on a 28-day cycle, in the absence of toxicities, for 3 cycles, followed by 3 cycles of observation Treatment: 5-Azacitidine: subcutaneously on days 1-5 at a dose of 40 mg/m\^2 all trans retinoic acid: 45 mg/m\^2, will be taken orally on days 3-7 of each cycle, divided into two doses	0 / 6	0 / 6	5 / 6
'Delayed' 5-AZA+ATRAPatients will receive Lupron 7.5 mg x 1. Four weeks later, they will undergo "observation" every 28 days for 3 cycles. Thereafter, patients will receive 5-AZA+ATRA treatment on a 28-day cycle, in the absence of toxicities, for 3 cycles. Treatment: 5-Azacitidine: subcutaneously on days 1-5 at a dose of 40 mg/m\^2 all trans retinoic acid: 45 mg/m\^2, will be taken orally on days 3-7 of each cycle, divided into two doses -Taken for 3 cycles	0 / 8	0 / 8	8 / 8

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: Male
Age: from 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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

PepBank is a research reference. Talk to a doctor before you use any peptide.