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NCT03624660 · ClinicalTrials.gov registry record · Phase 2
Dose-Escalated Proton Radiation Therapy for High-Risk Prostate Cancer
A Phase 2 study of Adenocarcinoma of the Prostate, sponsored by University of Florida.
- Active
- Registry status
- Phase 2
- Development phase
- 100
- Enrollment target
- 1
- Study location
NCT03624660: Active Phase 2 study of Adenocarcinoma of the Prostate, sponsored by University of Florida.
NCT03624660 is a Phase 2 study of Adenocarcinoma of the Prostate that is active but no longer recruiting, run by University of Florida. The registered enrollment target is 100 participants, roughly in line with the 105-participant average among 21 other Adenocarcinoma of the Prostate trials with a reported enrollment target. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03624660, a Phase 2 study of Adenocarcinoma of the Prostate, is active but no longer recruiting, sponsored by University of Florida.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 100 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this research study is to determine if dose-escalated proton radiation therapy is a good way to treat high-risk prostate cancer. The study features hypofractionation and a simultaneous integrated boost to the magnetic resonance imaging (MRI) identified intraprostatic tumor (IPT) as a method of dose-escalating radiation therapy. The study will include patients with high-risk prostate cancer who are at the highest risk for recurrence. Radiation therapy will be delivered over the course of 8-9 weeks. Additionally, androgen deprivation therapy (ADT) will be started 8-10 weeks prior to starting radiation and continued for a total of 18 months if the patient decides to receive ADT.
Primary Outcome
Biochemical failure will be defined based on the Phoenix definition. Biochemical failure has occurred if the post-treatment prostate-specific antigen (PSA) on at least two occasions rose more than 2 ng/ml above the PSA nadir. Rate of biochemical failure will be measured at 5 years after the end of treatment.
Conditions Studied
Interventions
- RADIATION HR-A
- RADIATION HR-B
Study Locations (1)
Florida
- University of Florida Health Proton Therapy Institute - Jacksonville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2018-09-24 |
| Est. Completion | 2028-09 |
| Phase | Phase 2 |
What the registry record for NCT03624660 still lists
NCT03624660 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 105-participant average among 21 other Adenocarcinoma of the Prostate trials with a reported enrollment target.
The record links to 1 condition, with Adenocarcinoma of the Prostate appearing as the primary indexed condition, and to 2 interventions - of which HR-A is the first listed.
NCT03624660 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT03624660 about?
NCT03624660 is a clinical study titled "Dose-Escalated Proton Radiation Therapy for High-Risk Prostate Cancer". The purpose of this research study is to determine if dose-escalated proton radiation therapy is a good way to treat high-risk prostate cancer. The study features hypofractionation and a simultaneous integrated boost to the magnetic resonance imaging (MRI) identified intraprostatic tumor (IPT) as a ...
What is the current status of trial NCT03624660?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 100 participants. The study started on 2018-09-24. Estimated completion is 2028-09.
What conditions does trial NCT03624660 study?
This clinical trial studies the following conditions: Adenocarcinoma of the Prostate.
What interventions are being tested in trial NCT03624660?
The interventions under investigation include: HR-A (RADIATION), HR-B (RADIATION).
Who is sponsoring clinical trial NCT03624660?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03624660 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
Similar trials for Adenocarcinoma of the Prostate
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03624660's enrollment target sits among peer trials
100 5th of 21 higher than 16 of 21 other Adenocarcinoma of the Prostate trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Adenocarcinoma of the Prostate 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.
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