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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Prostate Cancer
• Intervention / Treatment: Drug: 68Ga-HBED-CC-PSMA

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.

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

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

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
Genitourinary and gastrointestinal toxicity 12 months 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	Baseline to 1 year post-treatment
Feasibility of meeting specified dose constraints	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	Baseline to 1 year post-treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute and late genitourinary and gastrointestinal toxicity	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.	Baseline to 5 years post-treatment
Biochemical control using Prostate-Specific Antigen (PSA) levels	Biochemical control will be defined according to the Phoenix criteria at 2 and 5 years after radiation therapy	Baseline to 5 years post-treatment
Patient-reported quality of life using the Expanded Prostate Cancer Index Composite (EPIC-26)	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.	Baseline to 5 years post-treatment
Screened Subjects	Measuring the proportion of screened subjects who are enrolled on the study	Through study completion, average of 2 years
Patient-reported quality of life using Prostate Cancer Symptom Indices (PCSI)	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.	Baseline to 5 years post-treatment

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

• University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 2022
• Primary Completion (Actual): February 7, 2024
• Study Completion (Actual): February 7, 2024

Study Registration Dates

• First Submitted: January 21, 2020
• First Submitted That Met QC Criteria: January 24, 2020
• First Posted (Actual): January 28, 2020

Study Record Updates

• Last Update Posted (Actual): March 21, 2024
• Last Update Submitted That Met QC Criteria: March 19, 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: LCCC1917

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