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Radiopharmaceutical

PSMA-PET/MRI + SBRT for Prostate Cancer

Phase 2

Waitlist Available

Led By Panayiotis Mavroidis, PhD

Research Sponsored by UNC Lineberger Comprehensive Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Low or favorable intermediate risk, based on the NCCN criteria

Histologically confirmed prostate adenocarcinoma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 5 years post-treatment

Awards & highlights

Study Summary

This trial is testing whether it's safe to use PSMA-PET/mpMRI to plan radiotherapy for prostate cancer, and whether it's feasible to target the main tumor with SBRT while meeting all other planning criteria.

Who is the study for?

Men over 18 with low or favorable intermediate-risk prostate cancer, as per NCCN criteria, can join this trial. They must be able to understand English and agree to the study's terms. Those with MRI contraindications, previous prostate surgeries, inflammatory bowel disease, or other recent cancers (except certain skin cancers) cannot participate.Check my eligibility

What is being tested?

The trial is testing if PSMA-PET/mpMRI can safely define radiotherapy targets in prostate cancer patients while adhering to current planning standards. It also examines the feasibility of a precise radiation therapy technique on specific lesions within the prostate.See study design

What are the potential side effects?

While not explicitly listed here, potential side effects may include typical reactions from PET/MRI imaging agents like mild allergic reactions or discomfort at the injection site. Radiation therapy might cause fatigue, urinary issues, and gastrointestinal symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 5 years post-treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 5 years post-treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 5 years post-treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Feasibility of meeting specified dose constraints

Genitourinary and gastrointestinal toxicity 12 months post-treatment

Secondary outcome measures

Acute and late genitourinary and gastrointestinal toxicity

Biochemical control using Prostate-Specific Antigen (PSA) levels

Patient-reported quality of life using Prostate Cancer Symptom Indices (PCSI)

+2 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: PMSA-PET/MRIExperimental Treatment1 Intervention

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

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

UNC Lineberger Comprehensive Cancer CenterLead Sponsor

351 Previous Clinical Trials

88,332 Total Patients Enrolled

12 Trials studying Prostate Cancer

2,611 Patients Enrolled for Prostate Cancer

Panayiotis Mavroidis, PhDPrincipal InvestigatorUniversity of North Carolina, Chapel Hill

Michael Repka, MDPrincipal InvestigatorUniversity of North Carolina, Chapel Hill

1 Previous Clinical Trials

9 Total Patients Enrolled

1 Trials studying Prostate Cancer

9 Patients Enrolled for Prostate Cancer

Media Library

68Ga-HBED-CC-PSMA (Radiopharmaceutical) Clinical Trial Eligibility Overview. Trial Name: NCT04243941 — Phase 2

Prostate Cancer Research Study Groups: PMSA-PET/MRI

Prostate Cancer Clinical Trial 2023: 68Ga-HBED-CC-PSMA Highlights & Side Effects. Trial Name: NCT04243941 — Phase 2

68Ga-HBED-CC-PSMA (Radiopharmaceutical) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04243941 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any opportunities for patients to participate in this experiment currently?

"Clinicaltrials.gov has reported that this clinical trial, which was initially posted on January 15th 2023, is no longer recruiting participants. However, there are currently 1321 alternative studies actively enrolling patients at the moment."

Answered by AI

What is the intent of this research endeavor?

"The main aim of this research, monitored from baseline up to 12 months post-treatment, is determining the practicality of meeting certain dosage specifications. Secondary objectives include investigating acute and late GI/GU toxicity according to CTCAE v 5.0 during radiotherapy as well as 1-60 months after; assessing patient quality of life via EPIC-26 prior and throughout radiotherapy in prostate cancer patients that have had PSMA PET/MRI scans; measuring the amount of screened subjects enrolled in the trial."

Answered by AI

Has the Food and Drug Administration greenlit 68Ga-HBED-CC-PSMA for commercial use?

"Our experts at Power rate 68Ga-HBED-CC-PSMA's safety as a 2 due to the lack of evidence regarding its efficacy, though there is some data confirming it is secure."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2022. "PSMA-PET/MRI Low- and Intermediate-Risk Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04243941.