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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PMSA-PET/MRI | Experimental | Patients scheduled to receive PMSA-PET/MRI scan in addition to standard of care CT scan prior to treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 68Ga-HBED-CC-PSMA | Drug | Radioactive tracer used during imaging to help detect PSMA expressing tumor cells |
|
| Measure | Description | Time Frame |
|---|---|---|
| Genitourinary and gastrointestinal toxicity 12 months 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 | Baseline to 1 year post-treatment |
| Feasibility of meeting specified dose constraints | Proportion of subjects who meet these criteria:
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 | Baseline to 1 year post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Acute and late genitourinary and gastrointestinal toxicity | 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. | Baseline to 5 years post-treatment |
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Inclusion Criteria:
Exclusion Criteria:
Male participants only, since this is a prostate cancer study
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| Name | Affiliation | Role |
|---|---|---|
| Michael Repka, MD | University of North Carolina, Chapel Hill | Principal Investigator |
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| Label | URL |
|---|---|
| University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials | View source |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000718244 | gallium 68 PSMA-11 |
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| Biochemical control using Prostate-Specific Antigen (PSA) levels | Biochemical control will be defined according to the Phoenix criteria at 2 and 5 years after radiation therapy | Baseline to 5 years post-treatment |
| Patient-reported quality of life using the Expanded Prostate Cancer Index Composite (EPIC-26) | 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. | Baseline to 5 years post-treatment |
| Screened Subjects | Measuring the proportion of screened subjects who are enrolled on the study | Through study completion, average of 2 years |
| Patient-reported quality of life using Prostate Cancer Symptom Indices (PCSI) | 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. | Baseline to 5 years post-treatment |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |