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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT04176497
Recruitment Status : Suspended (Recruitment temporarily paused due to COVID-19 and expected to resume.)
First Posted : November 25, 2019
Last Update Posted : May 4, 2020
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center

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 disease Intervention/treatment Phase
Prostate Cancer Drug: 68Ga-HBED-CC-PSMA 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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : July 2020
Estimated Primary Completion Date : January 1, 2022
Estimated Study Completion Date : January 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
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 Name: gallium Ga 68-labeled PSMA-11

Primary Outcome Measures :
  1. Toxicity after Radiation [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: Through study completion, average of 2 years ]
    Measuring the proportion of screen subjects who are enrolled on the study

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Male participants only as this is a prostate cancer study
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04176497

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United States, North Carolina
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
UNC Lineberger Comprehensive Cancer Center
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Principal Investigator: Trevor Royce, MD, MS, MPH University of North Carolina, Chapel Hill
Additional Information:
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Responsible Party: UNC Lineberger Comprehensive Cancer Center Identifier: NCT04176497    
Other Study ID Numbers: LCCC1908
First Posted: November 25, 2019    Key Record Dates
Last Update Posted: May 4, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases