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NCT05754580 · ClinicalTrials.gov registry record · NA
High-dose Brachytherapy Boost With Stereostatic Body Radiation Therapy to Intermediate or Higher Risk Prostate Cancer
A NA study of Prostatic Cancer, sponsored by University of Nebraska.
- Recruiting
- Registry status
- NA
- Development phase
- 53
- Enrollment target
- 1
- Study location
NCT05754580: Recruiting NA study of Prostatic Cancer, sponsored by University of Nebraska.
NCT05754580 is a NA study of Prostatic Cancer that is actively recruiting participants, run by University of Nebraska. The registered enrollment target is 53 participants, below the 2,990-participant average among 4 other Prostatic Cancer trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05754580, a NA study of Prostatic Cancer, is actively recruiting participants, sponsored by University of Nebraska.
- RECRUITING
- Registry status
- NA
- Development phase
- 53 participants
- Enrollment target
- 1
- Study location
Study Summary
The objective of this phase I/II trial is to prospectively evaluate the toxicity and therapeutic efficacy of Stereostatic Body Radiation Therapy (SBRT) to prostate and pelvic lymph nodes in combination with high-dose-rate (HDR) brachytherapy to the prostate in patients with localized unfavorable-intermediate risk or higher disease.
Primary Outcome
To evaluate acute GI or GU toxicity and patient reported symptoms outcomes of SBRT and HDR brachytherapy boost as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 with a scale of Grade 1 through Grade 5 with Grade 1 being mild and Grade 5 being death. The International Prostate Symptom Score (IPSS) will also be used with a scale of 1 through 35, with 1-7 being mild, 8-19 being moderate, and 20-35 being severe. And the International Index of Erectile Function Questio
Conditions Studied
Interventions
- RADIATION High Dose Brachytherapy
- RADIATION Stereostatic Body Radiation Therapy
Study Locations (1)
Nebraska
- University of Nebraska Medical Center - Omaha
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 53 participants |
| Start Date | 2023-08-29 |
| Est. Completion | 2027-10 |
| Phase | NA |
What NCT05754580 shows while recruiting
NCT05754580 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 53 participants, a relatively small participant target, below the 2,990-participant average among 4 other Prostatic Cancer trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Prostatic Cancer appearing as the primary indexed condition, and to 2 interventions - of which High Dose Brachytherapy is the first listed.
NCT05754580 reports a single indexed study location in Nebraska.
Frequently Asked Questions
What is clinical trial NCT05754580 about?
NCT05754580 is a clinical study titled "High-dose Brachytherapy Boost With Stereostatic Body Radiation Therapy to Intermediate or Higher Risk Prostate Cancer". The objective of this phase I/II trial is to prospectively evaluate the toxicity and therapeutic efficacy of Stereostatic Body Radiation Therapy (SBRT) to prostate and pelvic lymph nodes in combination with high-dose-rate (HDR) brachytherapy to the prostate in patients with localized unfavorable-int...
What is the current status of trial NCT05754580?
This trial is currently recruiting. It is a NA study. The enrollment target is 53 participants. The study started on 2023-08-29. Estimated completion is 2027-10.
What conditions does trial NCT05754580 study?
This clinical trial studies the following conditions: Prostatic Cancer.
What interventions are being tested in trial NCT05754580?
The interventions under investigation include: High Dose Brachytherapy (RADIATION), Stereostatic Body Radiation Therapy (RADIATION).
Who is sponsoring clinical trial NCT05754580?
This trial is sponsored by University of Nebraska, which has 407 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05754580 being conducted?
This trial has 1 study location across Nebraska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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