RECRUITING

Diagnostic Performance of Non-Endorectal Coil Multiparametric Magnetic Resonance Imaging of Prostate with Flexible AIR Coil (DoNEMAC Study)

Conditions

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

Multiparametric MRI (mpMRI) of the prostate is an important tool for diagnosis of clinically significant prostate cancer (csPCa) in men with an elevated serum prostate specific antigen, which can decrease the rate of unnecessary biopsies and reduce the incidence of over-diagnosis of non-csPCa. Furthermore, there is evidence that MRI is more accurate in detecting high-grade (Gleason grade group ≥3) versus low grade cancers (Gleason grade group \<2) and therefore may serve as a useful adjunct to prostate-specific antigen (PSA) testing, digital rectal examination, and prostatic biopsy to detect cancers that require definitive treatment as opposed to active surveillance. Many investigators, including our group, have shown the utility of preoperative mpMRI to assess the local extent of prostate cancer and for surgical planning.

Official Title

Diagnostic Performance of Non-Endorectal Coil Multiparametric Magnetic Resonance Imaging of Prostate with Flexible AIR Coil (DoNEMAC Study)

Quick Facts

Study Start:2022-07-18
Study Completion:2027-02-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05043012

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:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male, Age ≥ 18
  2. * Untreated, biopsy-proven with intermediate and high-risk (Gleason group grade \>/=2) adenocarcinoma of the prostate
  3. * Patient is being considered for curative-intent treatment with radical prostatectomy within 6 months following mpMRI
  4. * Patient has provided written informed consent for participation in this trial
  5. * Patient should be eligible for scanning at 3 T magnet
  1. * Low-risk adenocarcinoma of prostate
  2. * Patient has had any prior therapy for prostate cancer
  3. * A history of other active malignancy within the last 2 years
  4. * Prostate cancer with significant sarcomatoid or spindle cell or neuroendocrine small cell components
  5. * Cardiac pacemaker
  6. * Orthopedic hardware in the pelvis and spine.
  7. * Claustrophobia and/or receiving anesthesia
  8. * Contraindication for endorectal coil such as rectal bleeding, severe anal fissures or hemorrhoids, anal/rectal surgery, and lack of rectum.

Contacts and Locations

Study Contact

Tharakeswara Bathala, MBBS,MD
CONTACT
(713) 792-2533
TKBathala@mdanderson.org

Principal Investigator

Tharakeswara Bathala, MBBS,MD
PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center

Study Locations (Sites)

The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

  • Tharakeswara Bathala, MBBS,MD, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

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 Date2022-07-18
Study Completion Date2027-02-02

Study Record Updates

Study Start Date2022-07-18
Study Completion Date2027-02-02

Terms related to this study

Additional Relevant MeSH Terms

  • Prostate Cancer