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

March 19, 2024 updated by: UNC Lineberger Comprehensive Cancer Center

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Withdrawn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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
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
Baseline to 1 year post-treatment
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
Baseline to 1 year post-treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline to 5 years post-treatment
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
Baseline to 5 years post-treatment
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.
Baseline to 5 years post-treatment
Screened Subjects
Time Frame: Through study completion, average of 2 years
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)
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.
Baseline to 5 years post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UNC Lineberger Comprehensive Cancer Center

Investigators

  • Principal Investigator: Michael Repka, MD, University of North Carolina, Chapel Hill

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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