Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00214097 · ClinicalTrials.gov registry record · Phase 1
Phase I/II Hypofractionated Radiotherapy for Prostate Cancer
A Phase 1 study of Prostate Cancer, sponsored by University of Wisconsin, Madison.
- Completed
- Registry status
- Phase 1
- Development phase
- 347
- Enrollment target
- 1
- Study location
NCT00214097: Completed Phase 1 study of Prostate Cancer, sponsored by University of Wisconsin, Madison.
NCT00214097 is a Phase 1 study of Prostate Cancer that has completed, run by University of Wisconsin, Madison. The registered enrollment target is 347 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (43% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00214097, a Phase 1 study of Prostate Cancer, has completed, sponsored by University of Wisconsin, Madison.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 347 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to examine the clinical feasibility of using Intensity-modulated radiation therapy (IMRT) combined with daily pretreatment prostate localization to deliver increasingly hypofractionated treatment courses. Progressively larger fraction sizes will be delivered in a phase I design based on both acute and long-term tolerances to the treatment. The dose-per-fraction escalation design utilizes schemas that maintain an isoeffective dose for late effects, while predicting that tumor control will actually improve. The delivery of fewer, larger fractions of radiation, if proven effective and safe, would result in significant cost saving and more efficient use of resources. Phase II will commence with Maximum Tolerated Dose (MTD) finding with up to 200 additional patients being enrolled during this phase of the study.
Primary Outcome
To evaluate acute tolerances to dose-per-fraction escalation in the treatment of prostate cancer using optimized treatment of Intensity-modulated radiation therapy (IMRT), daily rectal balloon displacement, and transabdominal ultrasound localization of the prostate. For toxicities observed within the first 10 patients at each hypofractionation level, ≥20% acute grade 3 or higher GI or genitourinary (GU) toxicity will constitute a threshold toxicity level and will dictate a decrease in frequency
Conditions Studied
Interventions
- RADIATION Radiotherapy
Study Locations (1)
Wisconsin
- University of Wisconsin Hospital and Clinics - Madison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 347 participants |
| Start Date | 2002-10-14 |
| Est. Completion | 2017-08-21 |
| Phase | Phase 1 |
What the finished NCT00214097 record still lists
NCT00214097 is an interventional study that assigns participants to a tested intervention. The registered 347 participants enrollment target is mid-sized for trials with a published cap, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (43% lower).
The record links to 1 condition, with Prostate Cancer appearing as the primary indexed condition, and to 1 intervention - of which Radiotherapy is the first listed.
NCT00214097 reports a single indexed study location in Wisconsin.
Frequently Asked Questions
What is clinical trial NCT00214097 about?
NCT00214097 is a clinical study titled "Phase I/II Hypofractionated Radiotherapy for Prostate Cancer". The purpose of this study is to examine the clinical feasibility of using Intensity-modulated radiation therapy (IMRT) combined with daily pretreatment prostate localization to deliver increasingly hypofractionated treatment courses. Progressively larger fraction sizes will be delivered in a phase I...
What is the current status of trial NCT00214097?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 347 participants. The study started on 2002-10-14. Estimated completion is 2017-08-21.
What conditions does trial NCT00214097 study?
This clinical trial studies the following conditions: Prostate Cancer.
What interventions are being tested in trial NCT00214097?
The interventions under investigation include: Radiotherapy (RADIATION).
Who is sponsoring clinical trial NCT00214097?
This trial is sponsored by University of Wisconsin, Madison, which has 1,039 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00214097 being conducted?
This trial has 1 study location across Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Prostate Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00214097's enrollment target sits among peer trials
347 149th of 735 higher than 587 of 735 other Prostate Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostate Cancer 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
-
A Study to Evaluate Safety, Efficacy, and Pharmacokinetics in Participants With Advanced Solid Tumors
RECRUITING · Phase 1
-
Phase 1 Trial of ZM008 as Single Agent and in Combination With Pembrolizumab in Patients With Advanced Solid Tumors
RECRUITING · Phase 1
-
Study of JANX007 in Subjects With Metastatic Castration-Resistant Prostate Cancer (ENGAGER-PSMA-01)
RECRUITING · Phase 1
-
Study of STM-416p Administered to Patients Undergoing Radical Prostatectomy
RECRUITING · Phase 1
-
A Study to Learn How Safe AZD6621 is, How Well it Works, and How it Moves Throughout the Body Over Time, in Adult Male Participants With Metastatic Prostate Cancer
RECRUITING · Phase 1
-
Study of Orally Administered MOMA-313 in Participants With Advanced or Metastatic Solid Tumors
RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01742143 · 347 participants
Impact of ICCAN on Cancer Treatment Completion and Quality of Life
- NCT04877522 · 347 participants · Phase 4
Asciminib Roll-over Study
- NCT05834660 · 347 participants · NA
SAFETY-A for Promoting Equity in Suicide Prevention Outcomes in Schools
- NCT06963827 · 347 participants · Phase 3
A Study of Mezagitamab in Adults With Primary IgA Nephropathy Kidney Condition
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI