Using MRI to Identify Areas to Receive Lower Doses of Radiation Treatment in Men With Prostate Cancerdose Mapping to Preserve Quality of Life

Prostate Cancer Clinical Trial

Official title:

A Prospective Study of Lower Dose Radiation (LO-RADS) for Prostate Cancer Using MRI Dose Mapping to Preserve Quality of Life

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06171269
• Other study ID #: IRB23-1023
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 14, 2024
• Est. completion date: October 20, 2028

Study information

• Verified date: December 2023
• Source: University of Chicago
• Contact: Clinical Trials Intake
• Phone: 1-855-702-8222
• Email: cancerclinicaltrials[@]bsd.uchicago.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this research is to gather information on the safety and effectiveness of using an imaging technique called magnetic resonance imaging (MRI) to decrease radiation dose to the uninvolved prostate (areas of the prostate that do not clearly have cancer cells) while increasing radiation dose to the nodules (hardened areas of the prostate that have cancer cells).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: October 20, 2028
• Est. primary completion date: February 14, 2027
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult (= 18 years old) male patients with an ECOG Performance Status 0-2
• Histologically-confirmed, MRI-visible prostate adenocarcinoma with NCCN intermediate- or high-risk disease1 without extra-pelvic metastasis.

Exclusion Criteria:

• Distant metastases
• Prior active treatment for prostate cancer including radical prostatectomy, high-intensity focused ultrasound (HIFU), cryosurgery, ADT, or cytotoxic chemotherapy for treatment of prostate cancer. Patients with prostate cancer on active surveillance prior to the study are not excluded if they have not received active treatment.
• Prior pelvic radiotherapy including brachytherapy.
• Additional active concurrent malignancies (except localized cutaneous squamous or basal cell carcinomas).
• Comorbid conditions that, in the opinion of the treating radiation oncologist, preclude the patient from safely receiving the protocol-specified treatment including RT and/or ADT.
• Patients with contraindications to MRI including patients with ferromagnetic materials in their body (e.g. bioimplants, surgical hardware, shrapnel), patients who are unable to receive contrast due to history of allergy or impaired renal function (glomerular filtration rate < 30 mil/min), and patients unable to tolerate MRI for other reasons (e.g. significant claustrophobia).
• Patients for whom hydrogel or hyaluronic acid spacer will be placed.
• Patients incapable of giving informed consent.
• Patients who are unable to adhere to the experimental protocols for any reason.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Radiation:
• Radiation
Radiation to the prostate gland will be given daily (Mon-Friday) for 4 weeks.
• MRI
The study doctor will use an MRI scan to take pictures of the prostate gland. These images of the prostate gland will let the study doctor know which areas of the prostate contain cancer cells that need to be targeted with higher doses of radiation and which uninvolved areas to target with lower doses of radiation.

Other:
• Androgen Deprivation Therapy
Treatment of treating physician choice will be given for 6-24 months.

Locations

Country	Name	City	State
United States	University of Chicago Medicine Comprehensive Cancer Center	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in bowel related quality of life	Decrease by at least 5 points in bowel related endpoints as measured by Expanded Prostate Cancer Index Composite 26 (EPIC-26) questionnaire.	12 months after treatment
Secondary	Biochemical control	Number of participants that have failed ADT therapy after 2 years as shown by prostate specific antigen (PSA) levels..	2 year after start of treatment
Secondary	Relationship between Imaging findings and Pathologic (tissue) findings	Correlation between signs of cancer as seen by imaging and tissue (pathology)	12 months post treatment
Secondary	Treatment Side effects	Number of gastrointestinal, genitourinary, and sexual side effects that are grade 2 or above per the Common Terminology Criteria for Adverse Events (CTCAE)	12 months post treatment
Secondary	Patient reported quality of life	improvement in patient reported quality of life (shown higher scores of worse symptoms) of gastrointestinal, genitourinary, and sexual function as assess by Expanded Prostate Cancer Index (EPIC) questionnaires	12 months post treatment