Vessel Sparing Prostate Radiation Therapy

Cancer of the PROSTATE Clinical Trial

Official title:

Vessel Sparing Prostate Radiation Therapy: Dose Limitation to Critical Erectile Structures (Corpus Cavernosum and Internal Pudendal Artery) by MRI Based Treatment Planning

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02958787
• Other study ID #: UMCC 2004-0626
• Status: Completed
• Phase: Phase 2
• First received: October 28, 2016
• Last updated: February 1, 2018
• Start date: November 2004
• Est. completion date: October 2009

Study information

• Verified date: February 2018
• Source: University of Michigan Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Cancer of the PROSTATE
• Prostatic Neoplasms

Intervention

Radiation:
• Radiation Therapy
Radiation Therapy Using MRI Based Treatment Planning

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	5 years from end of radiation treatment