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NCT03572387 · ClinicalTrials.gov registry record · Phase 2
A Pilot Study of 5-AZA and ATRA for Prostate Cancer With PSA-only Recurrence After Local Treatment
A Phase 2 study, sponsored by Icahn School of Medicine at Mount Sinai.
- Completed
- Registry status
- Phase 2
- Development phase
- 14
- Enrollment target
NCT03572387 is a Phase 2 study that has completed, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 14 participants.
The verdict
NCT03572387, a Phase 2 study, has completed, sponsored by Icahn School of Medicine at Mount Sinai.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 14 participants
- Enrollment target
Study 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.
Interventions
- DRUG Lupron
- DRUG 5-Azacitidine
- DRUG all trans retinoic acid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2018-08-20 |
| Est. Completion | 2022-07-08 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03572387
The ClinicalTrials.gov registry entry for NCT03572387 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Icahn School of Medicine at Mount Sinai, which has 708 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Lupron is the first listed.
NCT03572387 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03572387 about?
NCT03572387 is a clinical study titled "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 t...
What is the current status of trial NCT03572387?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 14 participants. The study started on 2018-08-20. Estimated completion is 2022-07-08.
What interventions are being tested in trial NCT03572387?
The interventions under investigation include: Lupron (DRUG), 5-Azacitidine (DRUG), all trans retinoic acid (DRUG).
Who is sponsoring clinical trial NCT03572387?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
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