Description:
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.
Title
- Brief Title: Study of PSMA PET/MR Guided Stereotactic Body Radiation Therapy With Simultaneous Integrated Boost (SBRT-SIB) for High-Intermediate and High Risk Prostate Cancer
- Official 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
Clinical Trial IDs
- ORG STUDY ID:
19-10020928
- SECONDARY ID:
R01CA249615
- NCT ID:
NCT04402151
Conditions
Interventions
| Drug | Synonyms | Arms |
|---|
| PSMA PET/MR - Gallium-68 labeled PSMA-HBED-CC | | Single Arm |
Purpose
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.
Detailed Description
Localized prostate cancer can be treated in 5 sessions using a precise, targeted form of
radiation known as stereotactic body radiation therapy (SBRT), with low toxicity. Despite
these advances, overall outcomes for aggressive (high risk) prostate cancer remain poor, with
10-year recurrence-free survival of approximately 65% regardless of treatment modality.
Recurrences are typically distant and carry poor prognosis, with 5 year survival of 25%. The
investigators propose to utilize the latest advances in cancer imaging (PSMA Positron
Emission Tomography (PET)/Magnetic Resonance Imaging (MR)) and radiation delivery (MR-guided
radiation therapy with real-time adaptive planning), to deliver a personalized radiation
treatment that targets the areas of greatest risk of recurrence in the prostate with improved
precision, and as a result improve clinical outcomes for individuals with high risk prostate
cancer. PSMA PET/MR is a novel imaging modality, not yet widely available, that augments the
tissue detail provided by MR. The combination of PSMA PET with MR results in improved
delineation of intraprostatic nodules and higher diagnostic accuracy for detection of
metastatic disease compared to conventional imaging. PSMA PET/MR imaging data is readily
transferable to a MR-based linear accelerator (MR-LINAC), a novel, innovative platform that
allows direct visualization of the tumor during treatment, and permits real-time
individualized correction for motion with online adaptive radiation planning.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| Single Arm | Other | Patients enrolling on the protocol will undergo prostate-specific membrane antigen (PSMA) Positron Emission Tomography (PET)/Magnetic Resonance(MR) prior to start of the radiation treatment planning process. PSMA tracer is administered by IV injection and PET images are acquired.
Any patients found to have possible metastatic disease will undergo a standard of care confirmatory biopsy (if feasible) and receive treatment appropriate for their stage.
The PSMA PET/MR scan will be performed prior to initiation of androgen deprivation therapy (ADT). | - PSMA PET/MR - Gallium-68 labeled PSMA-HBED-CC
|
Eligibility Criteria
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
| Maximum Eligible Age: | 90 Years |
| Minimum Eligible Age: | 21 Years |
| Eligible Gender: | Male |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | 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 |
| Time Frame: | 24 months |
| Safety Issue: | |
| Description: | 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 |
Secondary Outcome Measures
| Measure: | Performance of PSMA PET/MR to MR alone at staging prostate cancer |
| Time Frame: | Baseline |
| Safety Issue: | |
| Description: | 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. |
| Measure: | Performance of PSMA PET/MR to MR alone for identification of dominant intraprostatic nodules during radiation planning |
| Time Frame: | Baseline |
| Safety Issue: | |
| Description: | 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. |
| Measure: | Compare imaging biomarkers of interest on MR and PSMA PET/MR as predictors of treatment response, versus biopsy of treatment response and PSA |
| Time Frame: | Baseline |
| Safety Issue: | |
| Description: | |
| Measure: | Compare imaging biomarkers of interest on MR and PSMA PET/MR as predictors of treatment response, versus biopsy of treatment response and PSA |
| Time Frame: | 12 months |
| Safety Issue: | |
| Description: | |
| Measure: | Change in Quality of life questionnaires (EPIC-26) will be assessed. |
| Time Frame: | Baseline, 1month, 6months, 12 months, 18 months and 24 months. |
| Safety Issue: | |
| Description: | 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. |
| Measure: | Change in The American Urological Association (AUA) symptom score |
| Time Frame: | Baseline, 1month, 6months, 12 months, 18 months and 24 months. |
| Safety Issue: | |
| Description: | 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. |
| Measure: | Change in Number of Subjects with Adverse events |
| Time Frame: | Baseline, 1month, 6months, 12 months and 24 months. |
| Safety Issue: | |
| Description: | Adverse events will be collected from patients based on CTCAE version 5.0. |
| Measure: | 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). |
| Time Frame: | Baseline, 1month |
| Safety Issue: | |
| Description: | PTV is the planning target volume |
| Measure: | Compare the changes in the Microbiome during SBRT-SIB |
| Time Frame: | Baseline |
| Safety Issue: | |
| Description: | Gut microbiome samples will be obtained for 16S RNA analyses |
| Measure: | Compare the changes in the Microbiome during SBRT-SIB |
| Time Frame: | approx. 3 weeks |
| Safety Issue: | |
| Description: | Gut microbiome samples will be obtained for 16S RNA analyses |
| Measure: | Compare the changes in the Microbiome during SBRT-SIB |
| Time Frame: | 12 months |
| Safety Issue: | |
| Description: | Gut microbiome samples will be obtained for 16S RNA analyses |
| Measure: | Compare the immunological changes during SBRT-SIB |
| Time Frame: | Baseline |
| Safety Issue: | |
| Description: | serum samples will be obtained for immune correlate analyses |
| Measure: | Compare the immunological changes during SBRT-SIB |
| Time Frame: | approx. 3 weeks |
| Safety Issue: | |
| Description: | serum samples will be obtained for immune correlate analyses |
| Measure: | Compare the immunological changes during SBRT-SIB |
| Time Frame: | 12 months |
| Safety Issue: | |
| Description: | serum samples will be obtained for immune correlate analyses |
Details
| Phase: | Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | Weill Medical College of Cornell University |
Last Updated
July 15, 2021
