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NCT02353819 · ClinicalTrials.gov registry record · Phase 1

Stereotactic Ablative Radiotherapy (SABR) of Pelvis and Prostate Targets For High Risk Prostate Cancer

A Phase 1 study of Prostate Cancer, sponsored by University of Texas Southwestern Medical Center.

Active
Registry status
Phase 1
Development phase
60
Enrollment target
1
Study location

NCT02353819 is a Phase 1 study of Prostate Cancer that is active but no longer recruiting, run by University of Texas Southwestern Medical Center. The registered enrollment target is 60 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT02353819, a Phase 1 study of Prostate Cancer, is active but no longer recruiting, sponsored by University of Texas Southwestern Medical Center.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
60 participants
Enrollment target
1
Study location

Study Summary

Since high risk prostate cancer requires higher radiation, this study is being done to determine the maximum tolerated dose of radiation to the prostate and pelvic regions. Also to determine the feasibility and safety of each treatment fraction by using cone-beam Computed Tomography(CT) information and high speed Graphics Processing Unit based computation treatment planning systems. We also plan to determine the safety of treatment to the prostate. Health-related quality of life will be measured as part of current clinical practice. * Determine the maximum tolerated dose (MTD) or to safely escalate dose to the pelvic nodal using 90 day acute toxicity endpoint * Determine feasibility and safety of adaptive real time re-planning of the pelvic nodal region at each treatment fraction by using cone-beam CT (CBCT) information and high speed GPU based computation treatment planning systems * Determine the safety and tolerability of 9.5 Gy per fraction in five fractions (47.5 Gy total dose) to the prostate * Determine the feasibility and safety of temporal enhanced ultrasound for prostate lesion tracking during radiation therapy * To follow tumor related outcomes (i.e. PSA control, progression-free survival (PFS), distant metastasis (DM) free survival, and overall survival (OS) * Health-related quality of life (HRQOL) will be measured as part of current clinical practice Patients in each dose cohort will all be treated as a single group for dose escalation. There will be two levels of dose escalation-to prostate lesions and to pelvic lymph node region. Prostate/SV PTV will be treated at a fixed dose of 9.5 Gy per fraction for 5 fractions (47.5 Gy) based on our previous phase I/II study experiences. The starting dose for the dose escalation to the pelvic region PTV will be 4.5 Gy per fraction for 5 fractions (total dose= 22.5 Gy). Subsequent cohorts of patients will receive an additional 0.5 Gy per treatment (total 2.5 Gy per escalation). The starting dose for MRI-visible p

Conditions Studied

Prostate Cancer

Interventions

  • RADIATION Stereotactic Ablative Radiotherapy

Study Locations (1)

Texas

  • University of Texas Southwestern Medical Center - Dallas

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2015-10
Est. Completion 2030-12
Phase Phase 1

Sponsor

University of Texas Southwestern Medical Center

837 total trials

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What the Registry Record Tells You About NCT02353819

The ClinicalTrials.gov registry entry for NCT02353819 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (90% lower). The listed sponsor is University of Texas Southwestern Medical Center, which has 837 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Prostate Cancer appearing as the primary indexed condition, and to 1 intervention - of which Stereotactic Ablative Radiotherapy is the first listed.

NCT02353819 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.

Frequently Asked Questions

What is clinical trial NCT02353819 about?

NCT02353819 is a clinical study titled "Stereotactic Ablative Radiotherapy (SABR) of Pelvis and Prostate Targets For High Risk Prostate Cancer". Since high risk prostate cancer requires higher radiation, this study is being done to determine the maximum tolerated dose of radiation to the prostate and pelvic regions. Also to determine the feasibility and safety of each treatment fraction by using cone-beam Computed Tomography(CT) information ...

What is the current status of trial NCT02353819?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2015-10. Estimated completion is 2030-12.

What conditions does trial NCT02353819 study?

This clinical trial studies the following conditions: Prostate Cancer.

What interventions are being tested in trial NCT02353819?

The interventions under investigation include: Stereotactic Ablative Radiotherapy (RADIATION).

Who is sponsoring clinical trial NCT02353819?

This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02353819 being conducted?

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

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.