Back to resultsPSMA-PET/MRI Unfavorable-Risk Target Volume Pilot Study
Primary Purpose
Prostate Cancer
Status
Suspended
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
68Ga-HBED-CC-PSMA
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer
Eligibility Criteria
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
Sites / Locations
- University of North Carolina at Chapel Hill
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PMSA-PET/MRI
Arm Description
Patients scheduled to receive PMSA-PET/MRI scan in addition to standard of care CT scan prior to treatment
Outcomes
Primary Outcome Measures
Toxicity after Radiation
Change in toxicity after radiation relative to historical controls after using PSMA-PET/MRI to define radiotherapy targets
Secondary Outcome Measures
Adverse Events
Description of adverse events associated with using PSMA-PET/MRI to define radiotherapy target volumes in subjects with unfavorable-risk prostate cancer.
Biochemical control using Prostate-Specific Antigen (PSA) levels via the Phoenix definition
Evaluating biochemical control using PSA after radiotherapy in subjects who have received PSMA-PET/MRI to define radiotherapy target volumes.
Patient-reported quality of life using the Expanded Prostate Cancer Index Composite (EPIC-26) and Prostate Cancer Symptom Indices (PCSI)
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.
Screened Subjects
Measuring the proportion of screen subjects who are enrolled on the study
The feasibility of meeting dose constraints
The feasibility of meeting dose constraints will be defined as the proportion of subjects' radiotherapy treatment plan meets dose constraint criteria for PTV max, CTV, DIL, rectum, bladder, urethra, bowel, and penile bulb, as defined in the protocol.
Performance of PSMA-PET/MRI to PSMA PET/CT
Performance of PSMA-PET/MRI to PSMA PET/CT will be defined as rate of identification and delineation (e.g. sensitivity and specificity) of dominant intra-prostatic lesion in comparison to a gold standard of image-guided prostate biopsy.
Rate of identification of positive pelvic nodes and distant metastatic disease in the pelvis
Rate of identification of positive pelvic nodes and distant metastatic disease in the pelvis will be defined using PSMA-PET/MRI to PSMA PET/CT images
Full Information
NCT ID
NCT04176497
First Posted
November 15, 2019
Last Updated
June 20, 2023
Sponsor
UNC Lineberger Comprehensive Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT04176497
Brief Title
PSMA-PET/MRI Unfavorable-Risk Target Volume Pilot Study
Official Title
Image-Adapted Target Volumes Using 68Ga-HBED-CC PSMA-PET/MRI for Unfavorable-Risk Prostate Cancer Patients Receiving Radiation
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Suspended
Why Stopped
Other
Study Start Date
July 16, 2020 (Actual)
Primary Completion Date
January 1, 2026 (Anticipated)
Study Completion Date
January 1, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UNC Lineberger Comprehensive Cancer Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
42 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PMSA-PET/MRI
Arm Type
Experimental
Arm Description
Patients scheduled to receive PMSA-PET/MRI scan in addition to standard of care CT scan prior to treatment
Intervention Type
Drug
Intervention Name(s)
68Ga-HBED-CC-PSMA
Other Intervention Name(s)
gallium Ga 68-labeled PSMA-11
Intervention Description
Radioactive tracer used during imaging to help detect PSMA expressing tumor cells.
Primary Outcome Measure Information:
Title
Toxicity after Radiation
Description
Change in toxicity after radiation relative to historical controls after using PSMA-PET/MRI to define radiotherapy targets
Time Frame
End of treatment to 1 year post-treatment
Secondary Outcome Measure Information:
Title
Adverse Events
Description
Description of adverse events associated with using PSMA-PET/MRI to define radiotherapy target volumes in subjects with unfavorable-risk prostate cancer.
Time Frame
Baseline to 5 years post-treatment
Title
Biochemical control using Prostate-Specific Antigen (PSA) levels via the Phoenix definition
Description
Evaluating biochemical control using PSA after radiotherapy in subjects who have received PSMA-PET/MRI to define radiotherapy target volumes.
Time Frame
Baseline to 5 years post-treatment
Title
Patient-reported quality of life using the Expanded Prostate Cancer Index Composite (EPIC-26) and Prostate Cancer Symptom Indices (PCSI)
Description
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.
Time Frame
Baseline to 5 years post-treatment
Title
Screened Subjects
Description
Measuring the proportion of screen subjects who are enrolled on the study
Time Frame
Through study completion, average of 2 years
Title
The feasibility of meeting dose constraints
Description
The feasibility of meeting dose constraints will be defined as the proportion of subjects' radiotherapy treatment plan meets dose constraint criteria for PTV max, CTV, DIL, rectum, bladder, urethra, bowel, and penile bulb, as defined in the protocol.
Time Frame
Baseline
Title
Performance of PSMA-PET/MRI to PSMA PET/CT
Description
Performance of PSMA-PET/MRI to PSMA PET/CT will be defined as rate of identification and delineation (e.g. sensitivity and specificity) of dominant intra-prostatic lesion in comparison to a gold standard of image-guided prostate biopsy.
Time Frame
Baseline
Title
Rate of identification of positive pelvic nodes and distant metastatic disease in the pelvis
Description
Rate of identification of positive pelvic nodes and distant metastatic disease in the pelvis will be defined using PSMA-PET/MRI to PSMA PET/CT images
Time Frame
Baseline
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
Male participants only as this is a prostate cancer study
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 National Comprehensive Cancer Network (NCCN) criteria, with appropriate staging (e.g. bone scan) as defined in the protocol.
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Repka, MD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://unclineberger.org
Description
UNC Lineberger Comprehensive Cancer Center
Learn more about this trial
PSMA-PET/MRI Unfavorable-Risk Target Volume Pilot Study
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