PSMA-PET/MRI Low- and Intermediate-Risk Prostate Cancer

Overview

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.

Full Title of Study: “LCCC 1917: Dose Escalation of Low and Intermediate Risk Localized Prostate Cancer Using 68Ga-HBED-CC PSMA-PET/MRI and Stereotactic Body Radiotherapy”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 7, 2024

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

  • Drug: 68Ga-HBED-CC-PSMA
    • Radioactive tracer used during imaging to help detect PSMA expressing tumor cells

Arms, Groups and Cohorts

  • Experimental: PMSA-PET/MRI
    • Patients scheduled to receive PMSA-PET/MRI scan in addition to standard of care CT scan prior to treatment

Clinical Trial Outcome Measures

Primary Measures

  • Genitourinary and gastrointestinal toxicity 12 months post-treatment
    • Time Frame: 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
    • Time Frame: 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 Measures

  • Acute and late genitourinary and gastrointestinal toxicity
    • Time Frame: 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
    • Time Frame: 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)
    • Time Frame: 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
    • Time Frame: 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)
    • Time Frame: 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.

Participating in This Clinical Trial

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

Gender Eligibility: Male

Male participants only, since this is a prostate cancer study

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • UNC Lineberger Comprehensive Cancer Center
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Michael Repka, MD, Principal Investigator, University of North Carolina, Chapel Hill

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