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NCT02064036 · ClinicalTrials.gov registry record · Phase 1
Stereotactic Boost and Long-Term Androgen Deprivation for Adenocarcinoma of the Prostate
A Phase 1 study, sponsored by University of California, Davis.
- Completed
- Registry status
- Phase 1
- Development phase
- 17
- Enrollment target
NCT02064036: Completed Phase 1 study, sponsored by University of California, Davis.
NCT02064036 is a Phase 1 study that has completed, run by University of California, Davis. The registered enrollment target is 17 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02064036, a Phase 1 study, has completed, sponsored by University of California, Davis.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 17 participants
- Enrollment target
Study Summary
We hypothesize that Stereotactic Body Radiotherapy Boost (SBRT) as a boost to the prostate following whole pelvic intensity modulated radiotherapy (IMRT) can be delivered effectively and safely in a population of men with unfavorable intermediate and high risk localized prostate cancer. Our primary objective is to assess the feasibility and safety of a treatment strategy incorporating whole pelvic IMRT followed by an SBRT boost to the prostate with neoadjuvant, concurrent, and adjuvant androgen deprivation for a total of 28 months for men with unfavorable intermediate or high risk localized prostate cancer.
Primary Outcome
Tumors will be assessed using the American Joint Committee on Cancer (AJCC) Staging System, 7th Edition. This system consists of the following subscales: the extent of the primary tumor (T category), whether the cancer has spread to nearby lymph nodes (N category), the absence or presence of distant metastasis (M category), the PSA level at the time of diagnosis, and the Gleason score, based on the prostate biopsy (or surgery).
Interventions
- DRUG Leuprolide
- DRUG Casodex
- RADIATION Stereotactic Radiosurgical Boost
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2013-06-06 |
| Est. Completion | 2021-10-29 |
| Phase | Phase 1 |
What the finished NCT02064036 record still lists
NCT02064036 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 3 interventions - of which Leuprolide is the first listed.
NCT02064036 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02064036 about?
NCT02064036 is a clinical study titled "Stereotactic Boost and Long-Term Androgen Deprivation for Adenocarcinoma of the Prostate". We hypothesize that Stereotactic Body Radiotherapy Boost (SBRT) as a boost to the prostate following whole pelvic intensity modulated radiotherapy (IMRT) can be delivered effectively and safely in a population of men with unfavorable intermediate and high risk localized prostate cancer. Our primary...
What is the current status of trial NCT02064036?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 17 participants. The study started on 2013-06-06. Estimated completion is 2021-10-29.
What interventions are being tested in trial NCT02064036?
The interventions under investigation include: Leuprolide (DRUG), Casodex (DRUG), Stereotactic Radiosurgical Boost (RADIATION).
Who is sponsoring clinical trial NCT02064036?
This trial is sponsored by University of California, Davis, which has 657 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02064036's enrollment target sits among peer trials
17 1785th of 2000 higher than 215 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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