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

NCT04176497 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: LCCC1908
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Early Genitourinary and Gastrointestinal Toxicity

  Grade 3 or higher early genitourinary and gastrointestinal toxicities, defined by CTCAE version 5.0, include adverse events that develop within three months after starting radiation therapy. The NCI Common Terminology Criteria for Adverse Events is a descriptive terminology which can be utilized for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE term. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE.

  Up to 22 weeks (3 months after completion of radiation therapy)

Secondary Outcomes (9)

• Late Genitourinary Toxicity After Radiation

  Three months after starting radiation therapy to up to 48 months post-treatment

• Biochemical Control Using Prostate-Specific Antigen (PSA) Levels

  At 2 years after radiation therapy

• Patient-reported Quality of Life Using Prostate Cancer Symptom Indices (PCSI) Rectal Domain

  At 1, 3, 6, 9, 12, 18, 24, 30, 36, 42 months post radiotherapy

• Patient-reported Quality of Life Using Prostate Cancer Symptom Indices (PCSI) - Urinary Domain

  At 1, 3, 6, 9, 12, 18, 24, 30, 36, 42 months post radiotherapy

• Patient-reported Quality of Life Using the Expanded Prostate Cancer Index Composite (EPIC-26) Bowel Domain

  At 1, 3, 6, 9, 12, 18, 24, 30, 36, 42 months post radiotherapy

Study Arms (1)

PMSA-PET/MRI

EXPERIMENTAL

Patients scheduled to receive PMSA-PET/MRI scan in addition to standard of care CT scan prior to treatment

Drug: 68Ga-HBED-CC-PSMA

Interventions

68Ga-HBED-CC-PSMA DRUG

Radioactive tracer used during imaging to help detect PSMA expressing tumor cells.

Also known as: gallium Ga 68-labeled PSMA-11

PMSA-PET/MRI

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Male participants only as this is a prostate cancer study
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Related Links

• UNC Lineberger Comprehensive Cancer Center

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

gallium 68 PSMA-11

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Limitations and Caveats

This study was terminated before reaching target accrual and follow-up was suspended. Additionally, two versions of the protocol were uploaded since no new participant started to study after amendment.

Results Point of Contact

• Title: Melahat Canter
• Organization: UNC Lineberger Comprehensive Cancer Center

Melahat_Canter@med.unc.edu

919-966-4432

Study Officials

• Michael Repka, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2019
• First Posted: November 25, 2019
• Study Start: July 16, 2020
• Primary Completion: February 7, 2024
• Study Completion: October 25, 2024
• Last Updated: December 11, 2025
• Results First Posted: February 28, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)