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NCT03553602 · ClinicalTrials.gov registry record · Phase 1
HDR Brachytherapy, EBRT and STAD for the Treatment of Prostate Cancer
A Phase 1 study, sponsored by Loyola University.
- Terminated
- Registry status
- Phase 1
- Development phase
- 3
- Enrollment target
NCT03553602: Clinical Trial Phase 1 study, sponsored by Loyola University.
NCT03553602 is a Phase 1 study that was terminated before completion, run by Loyola University. The registered enrollment target is 3 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03553602, a Phase 1 study, was terminated before completion, sponsored by Loyola University.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 3 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety and effectiveness of combining high-dose-rate (HDR) brachytherapy with external beam radiotherapy (EBRT) to the pelvis and 6 months of hormonal therapy, otherwise known as short term androgen deprivation therapy (STAD), as treatment for prostate cancer that has come back in the prostate and pelvic lymph nodes after prior radiotherapy. The study will examine the side effects of the treatment as well as the ability of the treatment to get rid of the cancer. This involves the placement of a radioactive material in the affected area of the prostate temporarily, and then is subsequently removed using a minimally invasive technique. Participants will also receive external radiation for 5 weeks targeting the pelvis and giving a higher dose each day to the suspicious lymph nodes on PET scan. Radiation therapy will start approximately 2 months after the start of the Androgen Deprivation Therapy (hormone therapy). The hormone therapy consists of two medications, an oral medication taken daily 2 months before starting radiation therapy until the last of the radiation therapy and an injection of a medication which is given 2 months prior to the start of radiation. Patient are then followed at specific time intervals to evaluate the treatment side effects and cancer control
Primary Outcome
The primary outcome in this study is the number of participants with an acute grade ≥3 radiation-related genitourinary toxicity as described by the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Interventions
- DRUG HDR Brachytherapy + EBRT + STAD
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2017-12-20 |
| Est. Completion | 2024-07-26 |
| Phase | Phase 1 |
Why NCT03553602 stopped before completion
NCT03553602 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 1 intervention - of which HDR Brachytherapy + EBRT + STAD is the first listed.
NCT03553602 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03553602 about?
NCT03553602 is a clinical study titled "HDR Brachytherapy, EBRT and STAD for the Treatment of Prostate Cancer". The purpose of this study is to evaluate the safety and effectiveness of combining high-dose-rate (HDR) brachytherapy with external beam radiotherapy (EBRT) to the pelvis and 6 months of hormonal therapy, otherwise known as short term androgen deprivation therapy (STAD), as treatment for prostate ca...
What is the current status of trial NCT03553602?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 3 participants. The study started on 2017-12-20. Estimated completion is 2024-07-26.
What interventions are being tested in trial NCT03553602?
The interventions under investigation include: HDR Brachytherapy + EBRT + STAD (DRUG).
Who is sponsoring clinical trial NCT03553602?
This trial is sponsored by Loyola University, which has 92 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03553602's enrollment target sits among peer trials
3 1999th of 2000 higher than 1 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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