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NCT04486755 · ClinicalTrials.gov registry record · Phase 1
Hypofractionated Accelerated Pelvic Nodal Radiotherapy (GCC 2048)
A Phase 1 study of Prostate Cancer and Prostate Adenocarcinoma, sponsored by University of Maryland, Baltimore.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
- 1
- Study location
NCT04486755: Recruiting Phase 1 study of Prostate Cancer and Prostate Adenocarcinoma, sponsored by University of Maryland, Baltimore.
NCT04486755 is a Phase 1 study of Prostate Cancer and Prostate Adenocarcinoma that is actively recruiting participants, run by University of Maryland, Baltimore. The registered enrollment target is 18 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04486755, a Phase 1 study of Prostate Cancer and Prostate Adenocarcinoma, is actively recruiting participants, sponsored by University of Maryland, Baltimore.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
- 1
- Study location
Study Summary
A phase I trial to determine the safety of delivering three sequentially shorter RT schedules (20, 16, and 12 fractions) of HypoFx pelvic nodal RT in combination with a HypoFx, simultaneous integrated boost (SIB) to the prostate that have been designed to incrementally increased the biological equivalent dose (BED) to prostate cancer, while maintaining a constant BED to normal tissue toxicity.
Primary Outcome
The frequency of all observed acute GI, GU, hematologic, and neurologic dose limiting toxicities by CTCAE v5 grade will be tabulated. DLT is defined as treatment-related: Grade ≥3 GI (small bowel or rectal) toxicity, Grade ≥3 GU toxicity, Grade ≥3 hematologic, Grade ≥3 neurologic toxicity, or any grade 5 treatment-related adverse events.
Conditions Studied
Interventions
- RADIATION Hypofractionated Radiation Therapy
Study Locations (1)
Maryland
- Maryland Proton Treatment Center - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2020-11-19 |
| Est. Completion | 2027-08 |
| Phase | Phase 1 |
What NCT04486755 shows while recruiting
NCT04486755 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (97% lower).
The record links to 2 conditions, with Prostate Cancer appearing as the primary indexed condition, and to 1 intervention - of which Hypofractionated Radiation Therapy is the first listed.
NCT04486755 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT04486755 about?
NCT04486755 is a clinical study titled "Hypofractionated Accelerated Pelvic Nodal Radiotherapy (GCC 2048)". A phase I trial to determine the safety of delivering three sequentially shorter RT schedules (20, 16, and 12 fractions) of HypoFx pelvic nodal RT in combination with a HypoFx, simultaneous integrated boost (SIB) to the prostate that have been designed to incrementally increased the biological equiv...
What is the current status of trial NCT04486755?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2020-11-19. Estimated completion is 2027-08.
What conditions does trial NCT04486755 study?
This clinical trial studies the following conditions: Prostate Cancer, Prostate Adenocarcinoma.
What interventions are being tested in trial NCT04486755?
The interventions under investigation include: Hypofractionated Radiation Therapy (RADIATION).
Who is sponsoring clinical trial NCT04486755?
This trial is sponsored by University of Maryland, Baltimore, which has 560 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04486755 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Prostate Cancer
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 NCT04486755's enrollment target sits among peer trials
18 675th of 735 higher than 56 of 735 other Prostate Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostate Cancer 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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