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NCT05946824 · ClinicalTrials.gov registry record · Phase 2

This Study is Evaluating a New Radiation Treatment Technique for Patients Who Have Had Prostate Cancer, Undergone Surgery for Cancer, and Then Have Evidence That Their Prostate Cancer Has Returned.

A Phase 2 study of Recurrent Prostate Cancer After Surgery, sponsored by University of Rochester.

Recruiting
Registry status
Phase 2
Development phase
80
Enrollment target
1
Study location

NCT05946824: Recruiting Phase 2 study of Recurrent Prostate Cancer After Surgery, sponsored by University of Rochester.

NCT05946824 is a Phase 2 study of Recurrent Prostate Cancer After Surgery that is actively recruiting participants, run by University of Rochester. The registered enrollment target is 80 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (40% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05946824, a Phase 2 study of Recurrent Prostate Cancer After Surgery, is actively recruiting participants, sponsored by University of Rochester.

RECRUITING
Registry status
Phase 2
Development phase
80 participants
Enrollment target
1
Study location

Study Summary

There is significant, proven use of radiation for recurrent prostate cancer after surgical resection. This treatment typically is delivered over seven and a half weeks of daily treatments, presenting a burden to patients and the health care system. Stereotactic body radiation (SBRT) is a radiation technique in which large doses are delivered over a short period of time. To date there is extremely limited evidence in SBRT for recurrent prostate cancer after surgery, with a significantly growing body of evidence for primary SBRT treatment of prostate cancer in men who opt for non-surgical upfront treatment. Additionally, advances in imaging have allowed better detection of the site of recurrence, and novel artificial intelligence aided daily-adaptive radiation therapy have allowed more precise delivery of radiation doses. This study seeks to evaluate the role of Daily-Adaptive with AI-assisted SBRT in the post operative setting utilizing Ethos Plan Adaptive technology in attempt to maintain control and minimize side effects.

Primary Outcome

The Primary objective of the safety lead in component is to report acute, attributable genitourinary and gastrointestinal toxicity as scored by CTCAE v5.0.

Interventions

  • RADIATION Daily-adaptive Stereotactic Body Radiation Therapy

Study Locations (1)

New York

  • Wilmot Cancer Institute - Dept of Radiation Oncology - Rochester

Trial Details

FieldValue
Enrollment Target 80 participants
Start Date 2023-12-14
Est. Completion 2028-11-24
Phase Phase 2
University of Rochester

636 total trials

What NCT05946824 shows while recruiting

NCT05946824 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (40% lower).

The record links to 1 condition, with Recurrent Prostate Cancer After Surgery appearing as the primary indexed condition, and to 1 intervention - of which Daily-adaptive Stereotactic Body Radiation Therapy is the first listed.

NCT05946824 reports a single indexed study location in New York.

Frequently Asked Questions

What is clinical trial NCT05946824 about?

NCT05946824 is a clinical study titled "This Study is Evaluating a New Radiation Treatment Technique for Patients Who Have Had Prostate Cancer, Undergone Surgery for Cancer, and Then Have Evidence That Their Prostate Cancer Has Returned.". There is significant, proven use of radiation for recurrent prostate cancer after surgical resection. This treatment typically is delivered over seven and a half weeks of daily treatments, presenting a burden to patients and the health care system. Stereotactic body radiation (SBRT) is a radiation t...

What is the current status of trial NCT05946824?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 80 participants. The study started on 2023-12-14. Estimated completion is 2028-11-24.

What conditions does trial NCT05946824 study?

This clinical trial studies the following conditions: Recurrent Prostate Cancer After Surgery.

What interventions are being tested in trial NCT05946824?

The interventions under investigation include: Daily-adaptive Stereotactic Body Radiation Therapy (RADIATION).

Who is sponsoring clinical trial NCT05946824?

This trial is sponsored by University of Rochester, which has 636 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05946824 being conducted?

This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT05946824's enrollment target sits among peer trials

80 842nd of 2000 higher than 1,118 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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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Source: ClinicalTrials.gov NCT05946824, the US trial registry maintained by the National Library of Medicine. NCT05946824 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.