Prostate Cancer
Conditions
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.
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.
Interventions
Radioactive tracer used during imaging to help detect PSMA expressing tumor cells
Sponsors
UNC Lineberger Comprehensive Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| Screened Subjects | Through study completion, average of 2 years | Measuring the proportion of screened subjects who are enrolled on the study |
| 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 |
Outcome results
None listed