PSMA-PET/MRI Unfavorable-Risk Target Volume Pilot Study

UNC Lineberger Comprehensive Cancer Center (Other)
Overall Status
Suspended ID
Anticipated Duration (Months)
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The goal of this study is to investigate the feasibility and toxicity of using prostate-specific membrane antigen-positron emission tomography (PSMA-PET) and multi-parametric magnetic resonance imagining (mpMRI) with PET-MR technology to define radiotherapy targets, while meeting all the current planning criteria.

Condition or DiseaseIntervention/TreatmentPhase
Phase 2

Detailed Description

PSMA-PET is highly sensitive and specific for detecting prostate cancer. PSMA-PET and mpMRI can potentially help guide target volumes for patients with unfavorable-risk prostate cancer receiving radiation by designing a radiation treatment plan so that the entire prostate receives the prescribed dose of radiation in addition to the visible tumor in the prostate as detected by mpMRI and/or PSMA-PET receiving any inevitable intrinsic plan "hot spots" or areas of dose above the prescription.

Study Design

Study Type:
Anticipated Enrollment :
42 participants
Intervention Model:
Single Group Assignment
None (Open Label)
Primary Purpose:
Official Title:
Image-Adapted Target Volumes Using 68Ga-HBED-CC PSMA-PET/MRI for Unfavorable-Risk Prostate Cancer Patients Receiving Radiation
Actual Study Start Date :
Jul 16, 2020
Anticipated Primary Completion Date :
Jan 1, 2023
Anticipated Study Completion Date :
Jan 1, 2024

Arms and Interventions

Experimental: PMSA-PET/MRI

Patients scheduled to receive PMSA-PET/MRI scan in addition to standard of care CT scan prior to treatment

Radioactive tracer used during imaging to help detect PSMA expressing tumor cells.
Other Names:
  • gallium Ga 68-labeled PSMA-11
  • Outcome Measures

    Primary Outcome Measures

    1. Toxicity after Radiation [End of treatment to 1 year post-treatment]

      Change in toxicity after radiation relative to historical controls after using PSMA-PET/MRI to define radiotherapy targets

    Secondary Outcome Measures

    1. Adverse Events [Baseline to 5 years post-treatment]

      Description of adverse events associated with using PSMA-PET/MRI to define radiotherapy target volumes in subjects with unfavorable-risk prostate cancer.

    2. Biochemical control using Prostate-Specific Antigen (PSA) levels via the Phoenix definition [Baseline to 5 years post-treatment]

      Evaluating biochemical control using PSA after radiotherapy in subjects who have received PSMA-PET/MRI to define radiotherapy target volumes.

    3. Patient-reported quality of life using the Expanded Prostate Cancer Index Composite (EPIC-26) and Prostate Cancer Symptom Indices (PCSI) [Baseline to 5 years post-treatment]

      Measuring patient-reported quality of life using EPIC-26 and PCSI prior to radiation therapy and over time in subjects with prostate cancer who have received PSMA-PET/MRI to define radiotherapy target volumes.

    4. Screened Subjects [Through study completion, average of 2 years]

      Measuring the proportion of screen subjects who are enrolled on the study

    Eligibility Criteria


    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Accepts Healthy Volunteers:
    Inclusion Criteria:
    • Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.

    • Histologically confirmed prostate adenocarcinoma

    • Unfavorable intermediate or high-risk, based on the NCCN criteria28 (Appendix A.1), with appropriate staging (e.g. bone scan).

    • Subject has adequate performance status as defined by ECOG performance status of 0-2.

    • Subject is willing and able to comply with the protocol as determined by the Treating Investigator.

    • Subject speaks English (quality of life instrument is validated in English).

    Exclusion Criteria:
    • Contraindications for MRI

    • Other prior or concomitant malignancies with the exception of:

    • Non-melanoma skin cancer

    • Other cancer for which the subject has been disease free for ≥5 years before the first study treatment and of low potential risk for recurrence.

    • Inflammatory bowel disease

    • Absolute contraindications to brachytherapy per American Brachytherapy Society: unacceptable operative risk, absence of rectum, large TURP defects

    Contacts and Locations


    SiteCityStateCountryPostal Code
    1University of North Carolina at Chapel HillChapel HillNorth CarolinaUnited States27599

    Sponsors and Collaborators

    • UNC Lineberger Comprehensive Cancer Center


    • Principal Investigator: Trevor Royce, MD, MS, MPH, University of North Carolina, Chapel Hill

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:


    None provided.
    Responsible Party:
    UNC Lineberger Comprehensive Cancer Center Identifier:
    Other Study ID Numbers:
    • LCCC1908
    First Posted:
    Nov 25, 2019
    Last Update Posted:
    Nov 17, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Plan to Share IPD:
    Studies a U.S. FDA-regulated Drug Product:
    Studies a U.S. FDA-regulated Device Product:
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 17, 2021