Neoplasms

Symptoms and General Pathology

All Conditions

Neoplasm Metastasis

Neoplastic Processes

Analgesics

Central Nervous System Depressants

All Drugs and Chemicals

Narcotics

Diagnostic MRI

Planning MRI: high definition (HD) MRI of the region of interest (1 vertebral level above and below the level(s) being treated)

Planning MRI

Simulation CT is obtained (1.5 mm slice thickness)

Simulation CT

QOL assessment

Brief pain inventory (BPI), including narcotic assessment

Brief pain inventory (BPI)

sSRS in 1 fraction

sSRS 24 Gy in 2 fractions to be delivered either on consecutive days or one day apart.

sSRS in 2 fraction

Samuel T Chao, MD

Ehsan Balagamwala, MD

Samuel T. Chao, MD

Samuel Chao, MD

Spine radiosurgery (SRS) utilizes advanced treatment planning with focused x-rays to deliver one to four high dose treatments to the spine to help relieve pain and/or neurologic symptoms. Spine SRS uses special equipment to position the participant and guide the focused beams toward the area to be treated and away from normal tissue.

One of the side effects of spine SRS is the development of vertebral compression fractures, many of which are not painful. The goal of this study is to compare the effects, good and/or bad, of spine SRS given in 1 or 2 treatments. Our main goal is to find out which approach will reduce the chances of developing vertebral compression fractures.

The primary objective of this study is to establish the non-inferiority in vertebral compression fracture (VCF) incidence at 6 months between single-fraction and two-fraction sSRS.

Other objectives are to to evaluate the 12-month impact of single- and two-fraction sSRS on local control (LC), pain control (PC), quality of life (QOL), and toxicity (specifically, pain flare, radiation esophagitis/laryngitis/pharyngitis, and radiation myelitis)

This study is planned as a two-arm randomized phase II trial to establish non-inferiority of single fraction sSRS compared to two-fraction sSRS. Approximately 130 participants will be enrolled in this trial; 65 participants in each arm:

* Group 1: If you are assigned to this group, you will undergo spine radiosurgery in a single (1) session.
* Group 2: If you are assigned to this group, you will undergo spine radiosurgery in two (2) sessions.

Single- vs. Two-Fraction Spine Stereotactic Radiosurgery for the Treatment of Vertebral Metastases

All IPD that underlie results in publication, after de-identification

6-month cumulative incidence of Vertebral Compression Fracture (VCF) associated with single- and two-fraction sSRS

Each treated vertebra will be assessed individually for VCF during radiologic follow-up

LC as defined as absence of local progression of disease, which include the following:

1. Gross unequivocal increase in tumor volume or linear dimension.
2. Any new or progressive tumor within the epidural space.
3. Neurologic deterioration attributable to pre-existing epidural disease with equivocal increased epidural disease dimensions on MRI.

PC at each treated vertebral level assessed by the BPI \[9 item questionnaire (range: 0-10), higher scores = worse pain\], then defined by RTOG 0631 as follows:

Complete relief (CR): Pain score of 0 at index site 3 mo post-treatment. CR is requisite of no increase in narcotic analgesics.

Partial relief (PR): Reduction in BPI of ≥ 3 points at index site, provided other treated lesions have increased in pain score and participant did not require increase in narcotic analgesics for site of interest. Participants needing increase in narcotics for site will not be scored as having PR. Those needing increase in narcotics for a distant site will remain eligible for CR/PR.

Stable response (SR): Post-treatment pain score same as or within 2 points of baseline score at index site with no increase in narcotic analgesics for site of interest.

Progressive pain: Post-treatment increase of at least 3 points from baseline pain score at index site or increase in narcotics for site of interest.

Quality of life as measured by (EORTC QOL-C30) - 30 items that are grouped into five scales functional (physical, social, emotional functioning, cognitive and role), three scales of symptoms (fatigue, pain, nausea and vomiting), a global scale of health / quality of life and a number of related individual items with the symptoms of the disease and its treatment, as well as an item of economic impact. The answers to the items on the scales refer to "last week," except the patient's physical functioning scale whose time frame is the present. These answers obey a Likert format, which ranges from 1 ("Not at all") and 4 ("A lot")

Toxicity as assessed by criteria in the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

Rates of grade 1-5 toxicities will be reported

Case Comprehensive Cancer Center

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Participants will undergo diagnostic MRI exam followed by clinical biopsies of suspected prostate cancer tumors.

Participants will be scanned using a standard clinical prostate MRI protocol.

Participants will undergo a prostate biopsy as their standard of care treatment. The provider performing biopsy will select areas to be biopsies as part of normal clinical judgment.

Diagnostic Prostate Biopsy

The Risk Map DSS tool will select up to 2 additional areas to be biopsied based on analysis of MRI images. The clinical provider will make final decision on areas to be biopsied.

Risk Map DSS tool

Ambereen Yousuf

Aytekin Oto, MD

The purpose of the proposed research is to test and validate a Risk Map decision-support system (DSS) for prostate cancer Magnetic Resonance Imaging (MRI) interpretation and identification of clinically significant tumor site(s).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Single- vs. Two-Fraction Spine Stereotactic Radiosurgery for the Treatment of Vertebral Metastases	NCT04218617	Spine Metastase... Spine Stereotac...	Diagnostic MRI Planning MRI Simulation CT QOL assessment Brief pain inve... sSRS in 1 fract... sSRS in 2 fract...	18 Years -	Case Comprehensive Cancer Center
Developing an Imaging-Based Tool to Identify Areas for Prostate Cancer Biopsy	NCT03585660	Prostate Cancer	Diagnostic MRI Diagnostic Pros... Risk Map DSS to...	18 Years -	University of Chicago

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