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

Image-Adapted Target Volumes Using 68Ga-HBED-CC PSMA-PET/MRI for Unfavorable-Risk Prostate Cancer Patients Receiving Radiation

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Drug: 68Ga-HBED-CC-PSMA

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.

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina at Chapel Hill

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PMSA-PET/MRI; Patients scheduled to receive PMSA-PET/MRI scan in addition to standard of care CT scan prior to treatment	Drug: 68Ga-HBED-CC-PSMA; Radioactive tracer used during imaging to help detect PSMA expressing tumor cells.; Other Names: gallium Ga 68-labeled PSMA-11

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Toxicity after Radiation	Change in toxicity after radiation relative to historical controls after using PSMA-PET/MRI to define radiotherapy targets	End of treatment to 1 year post-treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events	Description of adverse events associated with using PSMA-PET/MRI to define radiotherapy target volumes in subjects with unfavorable-risk prostate cancer.	Baseline to 5 years post-treatment
Biochemical control using Prostate-Specific Antigen (PSA) levels via the Phoenix definition	Evaluating biochemical control using PSA after radiotherapy in subjects who have received PSMA-PET/MRI to define radiotherapy target volumes.	Baseline to 5 years post-treatment
Patient-reported quality of life using the Expanded Prostate Cancer Index Composite (EPIC-26) and Prostate Cancer Symptom Indices (PCSI)	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.	Baseline to 5 years post-treatment
Screened Subjects	Measuring the proportion of screen subjects who are enrolled on the study	Through study completion, average of 2 years
The feasibility of meeting dose constraints	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.	Baseline
Performance of PSMA-PET/MRI to PSMA PET/CT	Performance of PSMA-PET/MRI to PSMA PET/CT will be defined as rate of identification and delineation (e.g. sensitivity and specificity) of dominant intra-prostatic lesion in comparison to a gold standard of image-guided prostate biopsy.	Baseline
Rate of identification of positive pelvic nodes and distant metastatic disease in the pelvis	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	Baseline

Collaborators and Investigators

• Sponsor: UNC Lineberger Comprehensive Cancer Center
• Investigators: Principal Investigator: Michael Repka, MD, University of North Carolina, Chapel Hill

Publications and helpful links

Helpful Links

• UNC Lineberger Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): July 16, 2020
• Primary Completion (Actual): February 7, 2024
• Study Completion (Estimated): February 7, 2028

Study Registration Dates

• First Submitted: November 15, 2019
• First Submitted That Met QC Criteria: November 21, 2019
• First Posted (Actual): November 25, 2019

Study Record Updates

• Last Update Posted (Actual): March 25, 2024
• Last Update Submitted That Met QC Criteria: March 22, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms; Molecular Mechanisms of Pharmacological Action; Radiopharmaceuticals; Gallium 68 PSMA-11
• Other Study ID Numbers: LCCC1908

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No