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NCT04190446 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate Hypofractionated Proton Therapy or IMRT for Recurrent, Oligometastatic Prostate Cancer
A Phase 2 study of Prostate Adenocarcinoma and Recurrent Prostate Carcinoma, sponsored by Mayo Clinic.
- Active
- Registry status
- Phase 2
- Development phase
- 84
- Enrollment target
- 1
- Study location
NCT04190446: Active Phase 2 study of Prostate Adenocarcinoma and Recurrent Prostate Carcinoma, sponsored by Mayo Clinic.
NCT04190446 is a Phase 2 study of Prostate Adenocarcinoma and Recurrent Prostate Carcinoma that is active but no longer recruiting, run by Mayo Clinic. The registered enrollment target is 84 participants, below the 218-participant average among 99 other Prostate Adenocarcinoma trials with a reported enrollment target (61% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04190446, a Phase 2 study of Prostate Adenocarcinoma and Recurrent Prostate Carcinoma, is active but no longer recruiting, sponsored by Mayo Clinic.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 84 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase II trial studies the side effects of radiation therapy (hypofractionated proton beam therapy or IMRT) for the treatment of prostate cancer that has come back (recurrent) or that has spread to a limited number of sites (oligometastatic) following primary localized treatment. Hypofractionated proton beam radiation therapy delivers smaller doses of radiation therapy over time and may kill more tumor cells and have fewer side effects. IMRT uses high energy x-rays to kill tumor cells and shrink tumors. This trial is being done to find out if a shorter course of radiation therapy is better with fewer side effects for patients with recurrent prostate cancer.
Primary Outcome
Assessed by the number of patients who experience a late (≥ 90 days after RT start date) grade 3 or higher gastrointestinal (GI) and/or genitourinary (GU) adverse event (AE) defined as possibly, probably, or definitely related to radiation therapy (RT). Adverse events will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Conditions Studied
Interventions
- PROCEDURE Computed Tomography
- OTHER Quality-of-Life Assessment
- OTHER Questionnaire Administration
- RADIATION Intensity-Modulated Radiation Therapy
- RADIATION Proton Beam Radiation Therapy
Study Locations (1)
Minnesota
- Mayo Clinic in Rochester - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 84 participants |
| Start Date | 2020-01-06 |
| Est. Completion | 2028-11-22 |
| Phase | Phase 2 |
What the registry record for NCT04190446 still lists
NCT04190446 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 84 participants, a relatively small participant target, below the 218-participant average among 99 other Prostate Adenocarcinoma trials with a reported enrollment target (61% lower).
The record links to 5 conditions, with Prostate Adenocarcinoma appearing as the primary indexed condition, and to 5 interventions - of which Computed Tomography is the first listed.
NCT04190446 reports a single indexed study location in Minnesota.
Frequently Asked Questions
What is clinical trial NCT04190446 about?
NCT04190446 is a clinical study titled "A Study to Evaluate Hypofractionated Proton Therapy or IMRT for Recurrent, Oligometastatic Prostate Cancer". This phase II trial studies the side effects of radiation therapy (hypofractionated proton beam therapy or IMRT) for the treatment of prostate cancer that has come back (recurrent) or that has spread to a limited number of sites (oligometastatic) following primary localized treatment. Hypofractionat...
What is the current status of trial NCT04190446?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 84 participants. The study started on 2020-01-06. Estimated completion is 2028-11-22.
What conditions does trial NCT04190446 study?
This clinical trial studies the following conditions: Prostate Adenocarcinoma, Recurrent Prostate Carcinoma, Stage IV Prostate Cancer AJCC v8, Metastatic Prostate Adenocarcinoma, Oligometastatic Prostate Carcinoma.
What interventions are being tested in trial NCT04190446?
The interventions under investigation include: Computed Tomography (PROCEDURE), Quality-of-Life Assessment (OTHER), Questionnaire Administration (OTHER), Intensity-Modulated Radiation Therapy (RADIATION), Proton Beam Radiation Therapy (RADIATION).
Who is sponsoring clinical trial NCT04190446?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04190446 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Prostate Adenocarcinoma
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 NCT04190446's enrollment target sits among peer trials
84 47th of 99 higher than 53 of 99 other Prostate Adenocarcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostate Adenocarcinoma 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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