PSMA-PET/MRI Low- and Intermediate-Risk Prostate Cancer
Study Details
Study Description
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 |
|---|---|---|
| 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.
Study Design
Arms and Interventions
| 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 Names:
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Outcome Measures
Primary Outcome Measures
- Genitourinary and gastrointestinal toxicity 12 months post-treatment [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
- Feasibility of meeting specified dose constraints [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
- Acute and late genitourinary and gastrointestinal toxicity [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.
- Biochemical control using Prostate-Specific Antigen (PSA) levels [Baseline to 5 years post-treatment]
Biochemical control will be defined according to the Phoenix criteria at 2 and 5 years after radiation therapy
- Patient-reported quality of life using the Expanded Prostate Cancer Index Composite (EPIC-26) [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.
- Screened Subjects [Through study completion, average of 2 years]
Measuring the proportion of screened subjects who are enrolled on the study
- Patient-reported quality of life using Prostate Cancer Symptom Indices (PCSI) [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information
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Male subjects ≥ 18 years of age
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Histologically confirmed prostate adenocarcinoma
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Low or favorable intermediate risk, based on the NCCN criteria
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Subject has adequate performance status as defined by ECOG performance status of 0-2
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Subject is willing and able to comply with the protocol as determined by the Treating Investigator
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Subject speaks English (quality of life instrument is validated in English)
Exclusion Criteria:
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Contraindications for MRI
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Other prior or concomitant malignancies, with the exception of:
-
non-melanoma skin cancer
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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
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Inflammatory bowel disease
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Previous transurethral resection of the prostate (TURP) or surgery of the prostate
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of North Carolina - Chapel Hill | Chapel Hill | North Carolina | United States | 27599 |
Sponsors and Collaborators
- UNC Lineberger Comprehensive Cancer Center
Investigators
- Principal Investigator: Michael Repka, MD, University of North Carolina, Chapel Hill
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- LCCC1917