ACTIVE_NOT_RECRUITING

Biomarker Monitoring of Prostate Cancer Patients With RSI MRI (ProsRSI)

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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

Adult male patients with high-risk, localized prostate cancer and planning to undergo radiation therapy (RT) with androgen deprivation therapy (ADT) will undergo an advanced Magnetic Resonance Imaging (MRI) examination called Restriction Spectrum Imaging (RSI-MRI) to evaluate whether RSI-MRI can predict treatment response.

Official Title

A Phase II Biomarker Study of Restriction Spectrum Imaging (RSI) MRI in Patients With High-Risk, Localized Prostate Cancer Who Will Receive Radiotherapy and Androgen Deprivation Therapy

Quick Facts

Study Start:2020-12-29

Study Completion:2026-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04349501

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
* Male, aged ≥18 years, with histologically confirmed adenocarcinoma of the prostate * High-risk prostate cancer (any of: PSA ≥20 ng/mL or cT3-T4 stage or Gleason score ≥8) * Intended treatment and follow-up according to standard of care for prostate cancer * Planning to undergo definitive radiotherapy with neoadjuvant and concurrent androgen deprivation therapy * In good general health as evidenced by medical history and Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * Provision of signed and dated informed consent form * Stated willingness to comply with all study procedures and availability for the duration of the study	* Prior radiotherapy to the pelvis * Prior treatment for prostate cancer (cryotherapy, high frequency focused ultrasound, prostatectomy) * Hip prosthesis * Contraindication to MRI, per institutional requirements * Technetium-99 bone scan showing no clear evidence of distant metastasis * MRI or CT scan of the pelvis showing no clear evidence of bone or distant metastasis * Another malignancy, unless in remission or unlikely to impact the patient's survival or ability to receive standard care for prostate cancer (e.g., cutaneous basal cell carcinoma) * Patient has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.

Inclusion Criteria

Exclusion Criteria

* Male, aged ≥18 years, with histologically confirmed adenocarcinoma of the prostate
* High-risk prostate cancer (any of: PSA ≥20 ng/mL or cT3-T4 stage or Gleason score ≥8)
* Intended treatment and follow-up according to standard of care for prostate cancer
* Planning to undergo definitive radiotherapy with neoadjuvant and concurrent androgen deprivation therapy
* In good general health as evidenced by medical history and Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study

* Prior radiotherapy to the pelvis
* Prior treatment for prostate cancer (cryotherapy, high frequency focused ultrasound, prostatectomy)
* Hip prosthesis
* Contraindication to MRI, per institutional requirements
* Technetium-99 bone scan showing no clear evidence of distant metastasis
* MRI or CT scan of the pelvis showing no clear evidence of bone or distant metastasis
* Another malignancy, unless in remission or unlikely to impact the patient's survival or ability to receive standard care for prostate cancer (e.g., cutaneous basal cell carcinoma)
* Patient has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.

Contacts and Locations

Principal Investigator

Tyler Seibert, MD, PhD

PRINCIPAL_INVESTIGATOR

University of California, San Diego

Study Locations (Sites)

UCSD Moores Cancer Center

La Jolla, California, 92093

United States

Collaborators and Investigators

Sponsor: University of California, San Diego

Tyler Seibert, MD, PhD, PRINCIPAL_INVESTIGATOR, University of California, San Diego

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 Date2020-12-29

Study Completion Date2026-12

Study Record Updates

Study Start Date2020-12-29

Study Completion Date2026-12

Terms related to this study

Additional Relevant MeSH Terms

Prostate Cancer