PSMA-PET/MRI Unfavorable-Risk Target Volume Pilot Study

Phase 2

Active, not recruiting

Conditions: Prostate Cancer

Interventions: Drug: 68Ga-HBED-CC-PSMA

Registration Number: NCT04176497

Lead Sponsor: UNC Lineberger Comprehensive Cancer Center

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.

Recruitment & Eligibility

Status: ACTIVE_NOT_RECRUITING

Sex: Male

Target Recruitment: 7

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PMSA-PET/MRI	68Ga-HBED-CC-PSMA	Patients scheduled to receive PMSA-PET/MRI scan in addition to standard of care CT scan prior to treatment

Primary Outcome Measures

Name	Time	Method
Early Genitourinary Toxicity After Radiation	End of treatment to 1 year post-treatment	Grade 3+ late genitourinary toxicity and gastrointestinal toxicity as classified and graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 5.0

Secondary Outcome Measures

Name	Time	Method
Late Genitourinary Toxicity After Radiation	Baseline to 5 years post-treatment	Grade 3+ acute and late genitourinary and gastrointestinal toxicity will be defined according to CTCAE, version 5.0 during radiation therapy and at 18, 24, 30, 36, 42, 48, 54, and 60 months post-radiotherapy. Additionally, this will be reported as a cumulative incidence over the entire 5-year course of the study.
Biochemical Control Using Prostate-Specific Antigen (PSA) Levels	At 2 and 5 years after radiation therapy	Biochemical control will be defined according to the Phoenix criteria (PSA rise of 2 ng/mL over nadir).
The Feasibility of Meeting Dose Constraints	Baseline	The feasibility of meeting dose constraints will be defined as the proportion of subjects' radiotherapy treatment plan meets dose constraint criteria for PTV max, CTV, DIL, rectum, bladder, urethra, bowel, and penile bulb, as defined in the protocol.
Patient-reported Quality of Life Using the Expanded Prostate Cancer Index Composite (EPIC-26) and Prostate Cancer Symptom Indices (PCSI)	Baseline and at 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, and 60 months post radiotherapy	Measuring patient-reported quality of life using EPIC-26 and PCSI prior to radiation therapy and over time in subjects with prostate cancer who have received PSMA-PET/MRI to define radiotherapy target volumes. Patient-reported quality of life will be measured using the Expanded Prostate Cancer Index Composite (EPIC-26) and the Urinary Obstruction/Irritation scale of the validated Prostate Cancer Symptom Indices (PCSI). Patient-reported quality of life will be measured before the start of radiation therapy.
Screened Subjects	Through study completion	Measuring the proportion of screen subjects who are enrolled on the study
Performance of PSMA-PET/MRI to PSMA PET/CT	Baseline	Performance of PSMA-PET/MRI to PSMA PET/CT will be defined as the rate of identification and delineation (e.g. sensitivity and specificity) of the dominant intra-prostatic lesion in comparison to a gold standard of image-guided prostate biopsy. Rate of identification of positive pelvic nodes and Rate of identification of distant metastatic disease in the pelvis.
Rate of Identification of Positive Pelvic Nodes and Distant Metastatic Disease in the Pelvis	Baseline	Rate of identification of positive pelvic nodes and distant metastatic disease in the pelvis will be defined using PSMA-PET/MRI to PSMA PET/CT images