Vessel Sparing Prostate Radiation Therapy

NCT02958787 | Completed Phase 2 Results

• 1 other identifier: UMCC 2004-0626
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer of the PROSTATE

Outcome Measures

Primary Outcomes (1)

• 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: 1. Sexually active without aids 2. Sexually active with aids 3. Not sexually active with or without aids

  5 years from end of radiation treatment

Study Arms (1)

Intervention

EXPERIMENTAL

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

Radiation: Radiation Therapy

Interventions

Radiation Therapy RADIATION

Radiation Therapy Using MRI Based Treatment Planning

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

• 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.

  PMID: 28233591 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Results Point of Contact

• Title: Dr. Daniel Spratt, MD
• Organization: University of Michigan Comprehensive Cancer Center

sprattda@umich.edu

734-232-5244

Study Officials

• Daniel Spratt, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2016
• First Posted: November 8, 2016
• Study Start: November 1, 2004
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: March 5, 2018
• Results First Posted: March 5, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)