Clinical Trials /

Study of PSMA PET/MR Guided Stereotactic Body Radiation Therapy With Simultaneous Integrated Boost (SBRT-SIB) for High-Intermediate and High Risk Prostate Cancer

NCT04402151

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.

Related Conditions:
  • Prostate Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

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
  • NCT ID: NCT04402151

Conditions

  • Prostate Cancer

Interventions

DrugSynonymsArms
PSMA PET/MR - Gallium-68 labeled PSMA-HBED-CCSingle 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

NameTypeDescriptionInterventions
Single ArmOtherPatients 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:Not yet recruiting
Lead Sponsor:Weill Medical College of Cornell University

Last Updated

May 21, 2020