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NCT04879940 · ClinicalTrials.gov registry record · Phase 2
Phase II Study to Evaluate the Safety and Efficacy of Prostatic Artery Embolization
A Phase 2 study of Prostate Carcinoma and Benign Prostatic Hyperplasia, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Active
- Registry status
- Phase 2
- Development phase
- 17
- Enrollment target
- 1
- Study location
NCT04879940: Active Phase 2 study of Prostate Carcinoma and Benign Prostatic Hyperplasia, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
NCT04879940 is a Phase 2 study of Prostate Carcinoma and Benign Prostatic Hyperplasia that is active but no longer recruiting, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 17 participants, below the 1,502-participant average among 59 other Prostate Carcinoma trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04879940, a Phase 2 study of Prostate Carcinoma and Benign Prostatic Hyperplasia, is active but no longer recruiting, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 17 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a Phase II prospective clinical trial in which patients with prostate carcinoma and obstructive lower urinary tract symptoms electing for radiation therapy will undergo Prostatic Artery Embolization (PAE) prior to treatment. PAE will be administered by Interventional Radiology. Patients will be seen for follow-up at 6 weeks and 12 weeks following PAE after which they will start definitive radiotherapy. After completion of radiotherapy the patient will be seen at 12 weeks
Primary Outcome
Participants will take quality of life questionnaires including the International Prostate Symptom Score (IPSS)questionnaire to determine changes in prostate symptoms. Questionnaire will be taken at screening, Day 0- day of prostatic artery embolization (PAE), and at 6 weeks and 12 weeks after PAE. The IPSS asks the patient to rate urinary symptoms on a scale of 0-5, 0 indicating the participant has not had a symptom at all, and 5 indicating the symptom "almost always".
Conditions Studied
Interventions
- RADIATION Radiation Therapy
- DEVICE Merit Medical Embospheres
Study Locations (1)
Florida
- Moffitt Cancer Center - Tampa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2022-02-23 |
| Est. Completion | 2026-08 |
| Phase | Phase 2 |
What the registry record for NCT04879940 still lists
NCT04879940 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 1,502-participant average among 59 other Prostate Carcinoma trials with a reported enrollment target (99% lower).
The record links to 2 conditions, with Prostate Carcinoma appearing as the primary indexed condition, and to 2 interventions - of which Radiation Therapy is the first listed.
NCT04879940 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT04879940 about?
NCT04879940 is a clinical study titled "Phase II Study to Evaluate the Safety and Efficacy of Prostatic Artery Embolization". This is a Phase II prospective clinical trial in which patients with prostate carcinoma and obstructive lower urinary tract symptoms electing for radiation therapy will undergo Prostatic Artery Embolization (PAE) prior to treatment. PAE will be administered by Interventional Radiology. Patients will...
What is the current status of trial NCT04879940?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 17 participants. The study started on 2022-02-23. Estimated completion is 2026-08.
What conditions does trial NCT04879940 study?
This clinical trial studies the following conditions: Prostate Carcinoma, Benign Prostatic Hyperplasia.
What interventions are being tested in trial NCT04879940?
The interventions under investigation include: Radiation Therapy (RADIATION), Merit Medical Embospheres (DEVICE).
Who is sponsoring clinical trial NCT04879940?
This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04879940 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04879940's enrollment target sits among peer trials
17 56th of 59 higher than 4 of 59 other Prostate Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostate Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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