RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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

Quick Facts

Study Start:2024-01-05

Study Completion:2028-10-20

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06171269

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:MALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Clinical Trials Intake

CONTACT

1-855-702-8222

cancerclinicaltrials@bsd.uchicago.edu

Principal Investigator

Stanley Liauw

PRINCIPAL_INVESTIGATOR

University of Chicago

Study Locations (Sites)

University of Chicago Medicine Comprehensive Cancer Center

Chicago, Illinois, 60637

United States

Collaborators and Investigators

Sponsor: University of Chicago

Stanley Liauw, PRINCIPAL_INVESTIGATOR, University of Chicago

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-05

Study Completion Date2028-10-20

Study Record Updates

Study Start Date2024-01-05

Study Completion Date2028-10-20

Terms related to this study

Additional Relevant MeSH Terms

Prostate Cancer