Prostate Cancer Clinical Trial
Official title:
Image-Adapted Target Volumes Using 68Ga-HBED-CC PSMA-PET/MRI for Unfavorable-Risk Prostate Cancer Patients Receiving Radiation
Verified date | March 2024 |
Source | UNC Lineberger Comprehensive Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 9 |
Est. completion date | February 7, 2028 |
Est. primary completion date | February 7, 2024 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of North Carolina at Chapel Hill | Chapel Hill | North Carolina |
Lead Sponsor | Collaborator |
---|---|
UNC Lineberger Comprehensive Cancer Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Toxicity after Radiation | Change in toxicity after radiation relative to historical controls after using PSMA-PET/MRI to define radiotherapy targets | End of treatment to 1 year post-treatment | |
Secondary | Adverse Events | Description of adverse events associated with using PSMA-PET/MRI to define radiotherapy target volumes in subjects with unfavorable-risk prostate cancer. | Baseline to 5 years post-treatment | |
Secondary | 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. | Baseline to 5 years post-treatment | |
Secondary | 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. | Baseline to 5 years post-treatment | |
Secondary | Screened Subjects | Measuring the proportion of screen subjects who are enrolled on the study | Through study completion, average of 2 years | |
Secondary | 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. | Baseline | |
Secondary | 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. | Baseline | |
Secondary | 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 | Baseline |
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