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NCT00388804 · ClinicalTrials.gov registry record · Phase 3
External Beam Radiation Therapy (EBRT) With or Without Hormonal Therapy in Prostate Cancer
A Phase 3 study, sponsored by M.D. Anderson Cancer Center.
- Terminated
- Registry status
- Phase 3
- Development phase
- 39
- Enrollment target
NCT00388804: Clinical Trial Phase 3 study, sponsored by M.D. Anderson Cancer Center.
NCT00388804 is a Phase 3 study that was terminated before completion, run by M.D. Anderson Cancer Center. The registered enrollment target is 39 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00388804, a Phase 3 study, was terminated before completion, sponsored by M.D. Anderson Cancer Center.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 39 participants
- Enrollment target
Study Summary
Primary Objective: * To assess the possible improvement in prostate specific antigen (PSA) outcome of short course androgen suppression therapy in conjunction with dose-escalation intensity modulated radiation therapy (IMRT), 3D conformal radiation therapy (3D-CRT), or proton therapy over IMRT, 3D-CRT, or proton therapy alone in prostate cancer patients traditionally considered at intermediate risk for PSA failure following conventional local therapy. PSA failure will be the primary endpoint. Secondary Objectives: * To assess local control, freedom from distant metastasis, and overall survival. * To study the impact of radiation therapy and/or hormone therapy on health-related quality of life measures using the Expanded Prostate Cancer Index Composite-Short Form 12-American Urological Association Symptom Index (EPIC-SF12-AUASI: http://roadrunner.cancer.med.umich.edu/epic/). * To assess prognostic value of pretreatment serum testosterone as well as the decrease in hemoglobin from neoadjuvant hormone therapy. * To assess prognostic value of pretreatment biomarkers on subsequent post-treatment clinical outcomes.
Interventions
- DRUG Goserelin
- DRUG Bicalutamide
- DRUG Flutamide
- PROCEDURE Radiation Therapy
- DRUG Leuprolide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2005-02 |
| Est. Completion | 2011-04 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00388804
The ClinicalTrials.gov registry entry for NCT00388804 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 39 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is M.D. Anderson Cancer Center, which has 2,692 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Goserelin is the first listed.
NCT00388804 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00388804 about?
NCT00388804 is a clinical study titled "External Beam Radiation Therapy (EBRT) With or Without Hormonal Therapy in Prostate Cancer". Primary Objective: * To assess the possible improvement in prostate specific antigen (PSA) outcome of short course androgen suppression therapy in conjunction with dose-escalation intensity modulated radiation therapy (IMRT), 3D conformal radiation therapy (3D-CRT), or proton therapy over IMRT, 3D-...
What is the current status of trial NCT00388804?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 39 participants. The study started on 2005-02. Estimated completion is 2011-04.
What interventions are being tested in trial NCT00388804?
The interventions under investigation include: Goserelin (DRUG), Bicalutamide (DRUG), Flutamide (DRUG), Radiation Therapy (PROCEDURE), Leuprolide (DRUG).
Who is sponsoring clinical trial NCT00388804?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
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