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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, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower). 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.
Primary Outcome
Baseline + Post-radiation PSA levels at three month intervals for initial two years then every 6 months thereafter. Participants with a rising PSA and no evidence of local or distant recurrence considered PSA failures.
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 |
Why NCT00388804 stopped before completion
NCT00388804 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 5 interventions - of which Goserelin is the first listed.
NCT00388804 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00388804's enrollment target sits among peer trials
39 1898th of 2000 higher than 101 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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