Clinical trial NCT04176497: PSMA-PET/MRI Unfavorable-Risk Target Volume Pilot Study
Official title: Image-Adapted Target Volumes Using 68Ga-HBED-CC PSMA-PET/MRI for Unfavorable-Risk Prostate Cancer Patients Receiving Radiation
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Prostate Cancer
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2019-11-25
Enrollment: 7
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this study is to investigate the feasibility and toxicity of using prostate-specific membrane antigen-positron emission tomography (PSMA-PET) and multi-parametric magnetic resonance imagining (mpMRI) with PET-MR technology to define radiotherapy targets, while meeting all the current planning criteria.

Detailed description: PSMA-PET is highly sensitive and specific for detecting prostate cancer. PSMA-PET and mpMRI can potentially help guide target volumes for patients with unfavorable-risk prostate cancer receiving radiation by designing a radiation treatment plan so that the entire prostate receives the prescribed dose of radiation in addition to the visible tumor in the prostate as detected by mpMRI and/or PSMA-PET receiving any inevitable intrinsic plan "hot spots" or areas of dose above the prescription.

Eligibility criteria: Inclusion Criteria:

* Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.
* Histologically confirmed prostate adenocarcinoma
* Unfavorable intermediate or high-risk, based on the National Comprehensive Cancer Network (NCCN) criteria, with appropriate staging (e.g. bone scan) as defined in the protocol.
* 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
* Absolute contraindications to brachytherapy per American Brachytherapy Society: unacceptable operative risk, absence of rectum, large TURP defects

Primary outcomes:
measure: Early Genitourinary Toxicity After Radiation
timeFrame: End of treatment to 1 year post-treatment
Secondary outcomes:
measure: Late Genitourinary Toxicity After Radiation
timeFrame: Baseline to 5 years post-treatment
measure: Biochemical Control Using Prostate-Specific Antigen (PSA) Levels
timeFrame: At 2 and 5 years after radiation therapy
measure: Patient-reported Quality of Life Using the Expanded Prostate Cancer Index Composite (EPIC-26) and Prostate Cancer Symptom Indices (PCSI)
timeFrame: Baseline and at 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, and 60 months post radiotherapy
measure: Screened Subjects
timeFrame: Through study completion
measure: The Feasibility of Meeting Dose Constraints
timeFrame: Baseline
measure: Performance of PSMA-PET/MRI to PSMA PET/CT
timeFrame: Baseline
measure: Rate of Identification of Positive Pelvic Nodes and Distant Metastatic Disease in the Pelvis
timeFrame: Baseline
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Michael Repka, MD
role: PRINCIPAL_INVESTIGATOR
References: