Prostate Cancer Clinical Trial
— PSMA SBRT-SIBOfficial title:
Single-Arm Phase II Study of PSMA PET/MR Guided Stereotactic Body Radiation Therapy With Simultaneous Integrated Boost (SBRT-SIB) for High-Intermediate and High Risk Prostate Cancer
This is a single-arm Phase II clinical trial assessing the clinical efficacy of prostate specific membrane antigen (PSMA) PET/MR guided MR-LINAC based SBRT-SIB with planned accrual of 50 patients.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | December 31, 2025 |
Est. primary completion date | December 31, 2025 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 21 Years to 90 Years |
Eligibility | Inclusion Criteria: - Male aged 21 years or older. - Ability to provide signed informed consent and willingness to comply with protocol requirements. - Pathologic confirmation of high-risk adenocarcinoma of the prostate gland as follows: a. Gleason 8-10 or tertiary component 5 disease and/or b. PSA of 20 ng/ml or greater and/or c. Tumor stage of T2c or greater; OR Unfavorable intermediate risk (Gleason 4+3=7, >50% of cores involved, or 2 or more intermediate risk factors which include Gleason 7 disease, PSA 10-20, or T2b disease) - Participants must agree to use an acceptable form of birth control and utilize condoms for a period of seven days after each PSMA injection, if engaged in sexual activity. - No evidence of metastatic disease, including pelvic lymph nodes. Exclusion Criteria: - Clinical and/or technical factors that would compromise statistical analysis of the PET and/or MR. - Contraindications to PSMA IV administration - Contraindications to prostate SBRT (history of transurethral resection of prostate; prostate size greater than 150 cc; AUA score greater than 20; history of prior radiation to the prostate) - Other unspecified reasons that, in the opinion of investigators, make the subject unsuitable for enrollment - Patients on or intending to take abiraterone will be excluded |
Country | Name | City | State |
---|---|---|---|
United States | Weill Cornell Medicine | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Weill Medical College of Cornell University | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical efficacy of prostate-specific membrane antigen (PSMA) Positron Emission Tomography (PET)/Magnetic Resonance(MR), MR-Linear Accelerator (LINAC) will be assessed by evaluating recurrence free survival | Evaluate the clinical efficacy of PSMA PET/MR guided, MR-LINAC-based SBRT- SIB in high-intermediate and high risk prostate cancer, as evaluated by the 2-year recurrence-free survival rate | 24 months | |
Secondary | Performance of PSMA PET/MR to MR alone at staging prostate cancer | Detection of metastatic disease on each scan will be recorded, with pathologic confirmation obtained. Detection of intraprostatic nodules will be recorded with pathologic confirmation obtained. | Baseline | |
Secondary | Performance of PSMA PET/MR to MR alone for identification of dominant intraprostatic nodules during radiation planning | The Dominant Intraprostatic Nodules (DIN) will be defined with radiologist assistance on MR alone, and subsequently PSMA PET/MR. The incidence of alterations in target will be recorded. | Baseline | |
Secondary | Compare imaging biomarkers of interest on MR and PSMA PET/MR as predictors of treatment response, versus biopsy of treatment response and PSA | Baseline | ||
Secondary | Compare imaging biomarkers of interest on MR and PSMA PET/MR as predictors of treatment response, versus biopsy of treatment response and PSA | 12 months | ||
Secondary | Change in Quality of life questionnaires (EPIC-26) will be assessed. | Expanded Prostate Cancer Index Composite (EPIC) short form questionnaire. The Expanded Prostate Cancer Index Composite (EPIC) is a comprehensive instrument designed to evaluate patient function and bother after prostate cancer treatment. Scores range from 0 to 100, lower scores indicate worse outcomes and higher EPIC scores represent better outcomes. | Baseline, 1month, 6months, 12 months, 18 months and 24 months. | |
Secondary | Change in The American Urological Association (AUA) symptom score | The American Urological Association (AUA) has created this symptom index for understanding the severity of enlarged prostate symptoms. Scores ranging from 0-7 are considered to be mild symptoms, 8-19 are moderate and 20 - 35 are severe symptoms. | Baseline, 1month, 6months, 12 months, 18 months and 24 months. | |
Secondary | Change in Number of Subjects with Adverse events | Adverse events will be collected from patients based on CTCAE version 5.0. | Baseline, 1month, 6months, 12 months and 24 months. | |
Secondary | The change in radiation doses received by the surrounding normal structures/PTV for each initial and adapted plan will be analyzed with a signed-rank Wilcoxon test (non-parametric test for paired comparisons). | PTV is the planning target volume | Baseline, 1month | |
Secondary | Compare the changes in the Microbiome during SBRT-SIB | Gut microbiome samples will be obtained for 16S RNA analyses | Baseline | |
Secondary | Compare the changes in the Microbiome during SBRT-SIB | Gut microbiome samples will be obtained for 16S RNA analyses | approx. 3 weeks | |
Secondary | Compare the changes in the Microbiome during SBRT-SIB | Gut microbiome samples will be obtained for 16S RNA analyses | 12 months | |
Secondary | Compare the immunological changes during SBRT-SIB | serum samples will be obtained for immune correlate analyses | Baseline | |
Secondary | Compare the immunological changes during SBRT-SIB | serum samples will be obtained for immune correlate analyses | approx. 3 weeks | |
Secondary | Compare the immunological changes during SBRT-SIB | serum samples will be obtained for immune correlate analyses | 12 months |
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