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NCT02572284 · ClinicalTrials.gov registry record · Phase 1
Dose Escalation Study of Preoperative SBRT for High Risk Prostate Cancer
A Phase 1 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Completed
- Registry status
- Phase 1
- Development phase
- 7
- Enrollment target
NCT02572284: Completed Phase 1 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
NCT02572284 is a Phase 1 study that has completed, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 7 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02572284, a Phase 1 study, has completed, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 7 participants
- Enrollment target
Study Summary
The purpose of this study is to compare the effects, good and/or bad, of different doses of SBRT given before prostatectomy. Depending when participants enter the study, they will be treated with either 5 or 6 gray (Gy) per day of radiation. A Gy is a measure of radiation dose. The standard dose is 10Gy per day when SBRT is the only treatment to the prostate and no surgery is planned. The researchers want to see which dose of radiation will work best with the least amount of side effects. About 4-6 weeks after SBRT, participants will have a prostatectomy.
Primary Outcome
Acute dose-limiting toxicity and quality of life due to preoperative SBRT followed by robotic-assisted laparoscopic radical prostatectomy at 14 ± 5 days and 28 ± 5 days post-prostatectomy in high risk prostate cancer patients. In order to assess the toxicity of preoperative SBRT, the severity of specific events will be graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4 form where a score of ≥3 is considered dose-limiting.
Interventions
- RADIATION Stereotactic Body Radiation Therapy (SBRT)
- OTHER Quality of Life Questionnaires
- PROCEDURE Prostatectomy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2016-01-27 |
| Est. Completion | 2019-10-23 |
| Phase | Phase 1 |
What the finished NCT02572284 record still lists
NCT02572284 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 3 interventions - of which Stereotactic Body Radiation Therapy (SBRT) is the first listed.
NCT02572284 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02572284 about?
NCT02572284 is a clinical study titled "Dose Escalation Study of Preoperative SBRT for High Risk Prostate Cancer". The purpose of this study is to compare the effects, good and/or bad, of different doses of SBRT given before prostatectomy. Depending when participants enter the study, they will be treated with either 5 or 6 gray (Gy) per day of radiation. A Gy is a measure of radiation dose. The standard dose is ...
What is the current status of trial NCT02572284?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 7 participants. The study started on 2016-01-27. Estimated completion is 2019-10-23.
What interventions are being tested in trial NCT02572284?
The interventions under investigation include: Stereotactic Body Radiation Therapy (SBRT) (RADIATION), Quality of Life Questionnaires (OTHER), Prostatectomy (PROCEDURE).
Who is sponsoring clinical trial NCT02572284?
This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02572284's enrollment target sits among peer trials
7 1972nd of 2000 higher than 27 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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