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Anti-metabolites

Lupron for Prostate Cancer

Phase 2
Waitlist Available
Led By Vaibha G Patel, MD
Research Sponsored by Icahn School of Medicine at Mount Sinai
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights

Study Summary

This study is evaluating whether a combination of two drugs may help prevent prostate cancer from returning.

Eligible Conditions
  • Prostate Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
PSA Response Rate
Percentage of adverse events by grade
Secondary outcome measures
Measurement of BMP4 dormancy biomarker levels
Measurement of BMP7 dormancy biomarker levels
Measurement of GAS6 dormancy biomarker levels
+4 more

Side effects data

From 2018 Phase 3 trial • 2028 Patients • NCT00002597
44%
Acute RT Toxicity: Bowel: NOS
29%
Hormone Toxicity: Hot flashes : NOS
26%
Late RT Toxicity: Bowel: NOS
24%
Hormone Toxicity: Impotence : NOS
18%
Late RT Toxicity: Bladder: NOS
17%
Hormone Toxicity: Hematologic : NOS
15%
Acute RT Toxicity: Bladder: NOS
13%
Acute RT Toxicity: Hematologic: NOS
13%
Late RT Toxicity: Hematologic: NOS
13%
Acute RT Toxicity: Other: NOS
9%
Hormone Toxicity: Liver : NOS
8%
Late RT Toxicity: Other: NOS
7%
Late RT Toxicity: Other GU: NOS
100%
80%
60%
40%
20%
0%
Study treatment Arm
Neoadjuvant TAS 2 Months Before and During RT
Radiation Therapy Alone

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: (5-AZA) + (ATRA) combinationExperimental Treatment3 Interventions
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.
Group II: Lupron onlyActive Control1 Intervention
No treatment after one month of Lupron
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
5-Azacitidine
2011
Completed Phase 2
~130
Lupron
2018
Completed Phase 3
~2050
all trans retinoic acid
2018
Completed Phase 2
~20

Find a Location

Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiLead Sponsor
858 Previous Clinical Trials
524,277 Total Patients Enrolled
11 Trials studying Prostate Cancer
23,871 Patients Enrolled for Prostate Cancer
Vaibha G Patel, MDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Pilot Study of 5-AZA and ATRA for Prostate Cancer With PSA-only Recurrence After Local Treatment
Vaibhav G Patel 2018. "A Pilot Study of 5-AZA and ATRA for Prostate Cancer With PSA-only Recurrence After Local Treatment". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03572387.
~2 spots leftby Apr 2025
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