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NCT00956228 · ClinicalTrials.gov registry record · Phase 1
Study of Radioimmunoguided Intensity Modulated Radiotherapy (IMRT) for Prostate Cancer
A Phase 1 study of Prostatic Neoplasm, sponsored by Mayo Clinic.
- Completed
- Registry status
- Phase 1
- Development phase
- 72
- Enrollment target
- 1
- Study location
NCT00956228: Completed Phase 1 study of Prostatic Neoplasm, sponsored by Mayo Clinic.
NCT00956228 is a Phase 1 study of Prostatic Neoplasm that has completed, run by Mayo Clinic. The registered enrollment target is 72 participants, below the 245-participant average among 9 other Prostatic Neoplasm trials with a reported enrollment target (71% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00956228, a Phase 1 study of Prostatic Neoplasm, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 72 participants
- Enrollment target
- 1
- Study location
Study Summary
The current study involves a novel and aggressive therapeutic approach for patients' prostate cancer. In addition, the investigators propose to administer hormonal therapy to patients with an especially high risk: those with initial Gleason scores of \> 6, PSA \> 10 ng/ml, T3/T4 primary tumors, and those found to be node positive (N+). The use of hormonal therapy in these specific settings correlates with our current standard of care. IMRT is better able to spare and protect normal tissues from receiving radiation than 3-D conformal RT. The radiotherapy would be followed by continued hormonal therapy for a total of 6 months in those who have one of the following Gleason 7 and PSA 10-20 and as per the previous version of this trial, 1 year similar to that delivered by the EORTC for higher risk patients, (those with initial Gleason scores of \> 8, PSA \> 20 ng/ml, or T3/T4 tumors). Those found to be N(+) would have the hormonal therapy continued indefinitely or until disease progression occurred in a manner analogous to the Messing et. al. series in prostatectomy patients. The goals are to develop and administer a program of treatment that includes the most recent developments in imaging, integrating data from both the CT scan and the ProstaScint scan to optimize prostate cancer RT. The CT scan will be used for staging and to determine the exact location of the entire prostate which will receive a reasonable dose of RT. The ProstaScint will be used to assess the spread of disease to lymph nodes as well as to determine the exact location of the tumor within the prostate gland. This region will then be boosted to a tumorcidal dose. The investigators then plan to monitor the toxicity and outcome of this treatment. The investigators expect that this program of radioimmunoguided IMRT will likely result in similar or less toxicity and increased cure rates when compared to conventional radiotherapy and standard IMRT programs.
Conditions Studied
Interventions
- RADIATION radioimmuniguided intenstiy modulated radiotherapy
Study Locations (1)
Arizona
- Mayo Clinic - Scottsdale
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2006-10 |
| Est. Completion | 2007-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00956228
The ClinicalTrials.gov registry entry for NCT00956228 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 72 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 245-participant average among 9 other Prostatic Neoplasm trials with a reported enrollment target (71% lower). The listed sponsor is Mayo Clinic, which has 2,844 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Prostatic Neoplasm appearing as the primary indexed condition, and to 1 intervention - of which radioimmuniguided intenstiy modulated radiotherapy is the first listed.
NCT00956228 reports 1 study location spanning 1 distinct geographic area - top geographies include Arizona.
Frequently Asked Questions
What is clinical trial NCT00956228 about?
NCT00956228 is a clinical study titled "Study of Radioimmunoguided Intensity Modulated Radiotherapy (IMRT) for Prostate Cancer". The current study involves a novel and aggressive therapeutic approach for patients' prostate cancer. In addition, the investigators propose to administer hormonal therapy to patients with an especially high risk: those with initial Gleason scores of \> 6, PSA \> 10 ng/ml, T3/T4 primary tumors, and ...
What is the current status of trial NCT00956228?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 72 participants. The study started on 2006-10. Estimated completion is 2007-12.
What conditions does trial NCT00956228 study?
This clinical trial studies the following conditions: Prostatic Neoplasm.
What interventions are being tested in trial NCT00956228?
The interventions under investigation include: radioimmuniguided intenstiy modulated radiotherapy (RADIATION).
Who is sponsoring clinical trial NCT00956228?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00956228 being conducted?
This trial has 1 study location across Arizona. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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