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PSMA-PET/MRI Low- and Intermediate-Risk Prostate Cancer

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ClinicalTrials.gov Identifier: NCT04243941
Recruitment Status : Not yet recruiting
First Posted : January 28, 2020
Last Update Posted : November 4, 2020
Sponsor:
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center

Brief Summary:
The goal of this study is to determine the safety of using PSMA-PET/mpMRI to define radiotherapy targets, while meeting all current planning criteria. This study also intends to determine the feasibility of performing stereotactic body radiation therapy with simultaneous integrated boost on the dominant intra-prostatic lesions while meeting all current planning criteria.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: 68Ga-HBED-CC-PSMA Phase 2

Detailed Description:
This study aims to determine if multi-parametric magnetic resonance imaging (mpMRI) and prostate-specific membrane antigen-positron emission tomography (PSMA-PET) imaging can help optimize the placement of the high dose inhomogeneity characterizing stereotactic body radiation therapy. All radiation plans have "hot spots" of radiation, and in current practice these regions are randomly located. This study will focus those hot spots on regions determined by mpMRI + PSMA-PET to have visible tumor.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: LCCC 1917: Dose Escalation of Low and Intermediate Risk Localized Prostate Cancer Using 68Ga-HBED-CC PSMA-PET/MRI and Stereotactic Body Radiotherapy
Estimated Study Start Date : May 2021
Estimated Primary Completion Date : October 2023
Estimated Study Completion Date : May 2028

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
Drug: 68Ga-HBED-CC-PSMA
Radioactive tracer used during imaging to help detect PSMA expressing tumor cells
Other Name: gallium Ga 68-labeled PSMA-11




Primary Outcome Measures :
  1. Genitourinary and gastrointestinal toxicity 12 months post-treatment [ Time Frame: Baseline to 1 year post-treatment ]
    Grade 2+ GU/GI late toxicity as classified and graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 5.0 at 12 months after radiation therapy

  2. Feasibility of meeting specified dose constraints [ Time Frame: Baseline to 1 year post-treatment ]

    Proportion of subjects who meet these criteria:

    • Boost dose coverage: DIL D95% ≥ 44 Gy
    • Dose constraints:

    Urethra Dmax < 40 Gy

    Bladder Dmax < 45.6 Gy

    Bladder D10cc < 41.8 Gy

    Rectum Dmax < 38 Gy

    Rectal Mucosa D1% < 28.5 Gy

    Sigmoid Colon Dmax < 28.5 Gy



Secondary Outcome Measures :
  1. Acute and late genitourinary and gastrointestinal toxicity [ Time Frame: Baseline to 5 years post-treatment ]
    GU and GI toxicity as classified and graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. Will be measured during radiation therapy and at 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, and 60 months after radiotherapy.

  2. Biochemical control using Prostate-Specific Antigen (PSA) levels [ Time Frame: Baseline to 5 years post-treatment ]
    Biochemical control will be defined according to the Phoenix criteria at 2 and 5 years after radiation therapy

  3. Patient-reported quality of life using the Expanded Prostate Cancer Index Composite (EPIC-26) [ Time Frame: Baseline to 5 years post-treatment ]
    Measuring patient-reported quality of life using EPIC-26 prior to radiation therapy and over time in subjects with prostate cancer who have received PSMA-PET/MRI to define radiotherapy targets.

  4. Screened Subjects [ Time Frame: Through study completion, average of 2 years ]
    Measuring the proportion of screened subjects who are enrolled on the study

  5. Patient-reported quality of life using Prostate Cancer Symptom Indices (PCSI) [ Time Frame: Baseline to 5 years post-treatment ]
    Measuring patient-reported quality of life using PCSI prior to radiation therapy and over time in subjects with prostate cancer who have received PSMA-PET/MRI to define radiotherapy targets.



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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, since this is a prostate cancer study
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information
  • Male subjects ≥ 18 years of age
  • Histologically confirmed prostate adenocarcinoma
  • Low or favorable intermediate risk, based on the NCCN criteria
  • 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
  • Previous transurethral resection of the prostate (TURP) or surgery of the prostate

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 ClinicalTrials.gov identifier (NCT number): NCT04243941


Contacts
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Contact: Panayiotis Mavroidis, PhD 984-974-8438 panayiotis_mavroidis@med.unc.edu
Contact: Sarah Gadre 984-215-5425 sarah_gadre@med.unc.edu

Locations
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United States, North Carolina
University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
UNC Lineberger Comprehensive Cancer Center
Investigators
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Principal Investigator: Panayiotis Mavroidis, PhD University of North Carolina, Chapel Hill
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Responsible Party: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT04243941    
Other Study ID Numbers: LCCC1917
First Posted: January 28, 2020    Key Record Dates
Last Update Posted: November 4, 2020
Last Verified: November 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
Neoplasms
Prostatic Diseases