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Vessel Sparing Prostate Radiation Therapy

Primary Purpose

Cancer of the PROSTATE

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Radiation Therapy
Sponsored by
University of Michigan Rogel Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer of the PROSTATE

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Histologically confirmed diagnosis of prostate cancer
  • Patients must have measurable erectile function. Patients with erectile function on Viagra and drugs of the same class are eligible. Patients who require 6 months of hormonal therapy or less are eligible, provided baseline erectile function is measured prior to or within 14 days of the start of hormonal therapy.
  • Baseline PSA (Prostate Specific Antigen), TNM stage (a classification of malignant tumors in cancer), and Gleason Score (A system of grading prostate cancer tissue based on how it looks under a microscope): Patients with low (PSA less than 10, T2a or less, Gleason 6 or less), intermediate, or high (Gleason 8-10, T3a, PSA over 20) risk disease are eligible for this protocol. Patients on finasteride or drugs of the same class are eligible.
  • Patients must be 18 years or older. No upper age restriction.
  • Patients treated with external beam radiotherapy alone or external beam therapy plus implant therapy are eligible.
  • Patients must have an ECOG (Eastern Cooperative Oncology Group system of grading patient status that attempts to quantify cancer patients' general well-being and activities of daily life) performance status <2.
  • The patient must sign study specific informed consent approved by the IRB of U of M indicating they are aware of the investigational nature of the treatment.

Exclusion Criteria:

  • Patients who are impotent or have an IIEF (International Index of Erectile Function) <16.
  • Patients who are medically ineligible for radiation therapy due to other medical conditions.
  • Patients given hormonal therapy before baseline questionnaires filled out.
  • Patients who receive implant only therapy.
  • Patients unable to undergo MRI (Magnetic Resonance Imaging).

Sites / Locations

  • University of Michigan

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

Vessel Sparing Radiation Therapy using MRI based treatment planning to limit dose to critical erectile structures

Outcomes

Primary Outcome Measures

The Percentage of Patients Able to be Sexually Active With or Without the Use of Aids
The primary endpoint of the study was to accurately determine the preservation of erectile function post radiation therapy. Erectile preservation was defined as a score of 1 or 2 on the three-tier patient reported questionnaire equating to being able to be sexually active with or without aids. Scoring: Sexually active without aids Sexually active with aids Not sexually active with or without aids

Secondary Outcome Measures

Full Information

First Posted
October 28, 2016
Last Updated
February 1, 2018
Sponsor
University of Michigan Rogel Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT02958787
Brief Title
Vessel Sparing Prostate Radiation Therapy
Official Title
Vessel Sparing Prostate Radiation Therapy: Dose Limitation to Critical Erectile Structures (Corpus Cavernosum and Internal Pudendal Artery) by MRI Based Treatment Planning
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
October 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Michigan Rogel Cancer Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Prostate cancer patients have a number of excellent treatment options to consider, and quality of life following treatment is often a consideration in treatment choice. One critical quality of life concern for patients diagnosed with prostate cancer is sexual function. Previous studies point to a vascular mechanism of impotence post-radiation therapy, as opposed to a nerve-based mechanism following surgery. In this study, the critical vascular structures (internal pudendal artery and corpus cavernosum) are defined by MRI-based imaging and included in treatment planning for radiation treatments, hopefully preserving critical artery function. This study will collect erectile function preservation rates at 5-years post-vessel-sparing radiotherapy with or without aids using the patient reported using the simplified three-question erectile function scale.
Detailed Description
The vast majority of patients diagnosed with prostate cancer in the modern era of PSA screening have localized and potentially curable disease. Patients have a number of excellent treatment options to consider, and quality of life following treatment is often a consideration in treatment choice. One critical quality of life concern for patients diagnosed with prostate cancer is sexual function. Studies of sexual function post-radiation therapy fall into three categories: incidence studies; correlative (dose and toxicity) studies; mechanism(functional) studies. All these studies point to a vascular mechanism of impotence post-radiation therapy, as opposed to a nerve-based mechanism following surgery. In this study, the critical vascular structures (internal pudendal artery and corpus cavernosum) are defined by MRI-based imaging and included in treatment planning for radiation treatments. Investigators propose that this technique will improve quality of life, sexual function, and relapse-free survival. This study's primary aim is to determine erectile function preservation rates at 5-years post-vessel-sparing radiotherapy with or without aids using the patient reported using the simplified three-question erectile function scale.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer of the PROSTATE

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
135 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Vessel Sparing Radiation Therapy using MRI based treatment planning to limit dose to critical erectile structures
Intervention Type
Radiation
Intervention Name(s)
Radiation Therapy
Intervention Description
Radiation Therapy Using MRI Based Treatment Planning
Primary Outcome Measure Information:
Title
The Percentage of Patients Able to be Sexually Active With or Without the Use of Aids
Description
The primary endpoint of the study was to accurately determine the preservation of erectile function post radiation therapy. Erectile preservation was defined as a score of 1 or 2 on the three-tier patient reported questionnaire equating to being able to be sexually active with or without aids. Scoring: Sexually active without aids Sexually active with aids Not sexually active with or without aids
Time Frame
5 years from end of radiation treatment

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically confirmed diagnosis of prostate cancer Patients must have measurable erectile function. Patients with erectile function on Viagra and drugs of the same class are eligible. Patients who require 6 months of hormonal therapy or less are eligible, provided baseline erectile function is measured prior to or within 14 days of the start of hormonal therapy. Baseline PSA (Prostate Specific Antigen), TNM stage (a classification of malignant tumors in cancer), and Gleason Score (A system of grading prostate cancer tissue based on how it looks under a microscope): Patients with low (PSA less than 10, T2a or less, Gleason 6 or less), intermediate, or high (Gleason 8-10, T3a, PSA over 20) risk disease are eligible for this protocol. Patients on finasteride or drugs of the same class are eligible. Patients must be 18 years or older. No upper age restriction. Patients treated with external beam radiotherapy alone or external beam therapy plus implant therapy are eligible. Patients must have an ECOG (Eastern Cooperative Oncology Group system of grading patient status that attempts to quantify cancer patients' general well-being and activities of daily life) performance status <2. The patient must sign study specific informed consent approved by the IRB of U of M indicating they are aware of the investigational nature of the treatment. Exclusion Criteria: Patients who are impotent or have an IIEF (International Index of Erectile Function) <16. Patients who are medically ineligible for radiation therapy due to other medical conditions. Patients given hormonal therapy before baseline questionnaires filled out. Patients who receive implant only therapy. Patients unable to undergo MRI (Magnetic Resonance Imaging).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Spratt, MD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No sharing
Citations:
PubMed Identifier
28233591
Citation
Spratt DE, Lee JY, Dess RT, Narayana V, Evans C, Liss A, Winfield R, Schipper MJ, Lawrence TS, McLaughlin PW. Vessel-sparing Radiotherapy for Localized Prostate Cancer to Preserve Erectile Function: A Single-arm Phase 2 Trial. Eur Urol. 2017 Oct;72(4):617-624. doi: 10.1016/j.eururo.2017.02.007. Epub 2017 Feb 21.
Results Reference
derived

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Vessel Sparing Prostate Radiation Therapy

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