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

Sponsor
UNC Lineberger Comprehensive Cancer Center (Other)
Overall Status
Suspended
CT.gov ID
NCT04176497
Collaborator
(none)
42
Enrollment
1
Location
1
Arm
41.5
Anticipated Duration (Months)
1
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:
Interventional
Anticipated Enrollment :
42 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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

ArmIntervention/Treatment
Experimental: PMSA-PET/MRI

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

Drug: 68Ga-HBED-CC-PSMA
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

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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

    Locations

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

    Sponsors and Collaborators

    • UNC Lineberger Comprehensive Cancer Center

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    UNC Lineberger Comprehensive Cancer Center
    ClinicalTrials.gov Identifier:
    NCT04176497
    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:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 17, 2021