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Study of PSMA PET/MR Guided Stereotactic Body Radiation Therapy With Simultaneous Integrated Boost (SBRT-SIB) for High-Intermediate and High Risk Prostate Cancer

NCT04402151 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-01-26

No results posted yet for this study

Summary

This is a single-arm Phase II clinical trial assessing the clinical efficacy of prostate specific membrane antigen (PSMA) PET/MR guided MR-LINAC based SBRT-SIB with planned accrual of 50 patients.

Conditions

Interventions

DRUG

PSMA PET/MR - Gallium-68 labeled PSMA-HBED-CC

Patients enrolling on the protocol will undergo prostate-specific membrane antigen (PSMA) Positron Emission Tomography (PET)/Magnetic Resonance(MR) prior to start of the radiation treatment planning process. PSMA tracer is administered by IV injection and PET images are acquired. Any patients found to have possible metastatic disease will undergo a standard of care confirmatory biopsy (if feasible) and receive treatment appropriate for their stage. The PSMA PET/MR scan will be performed prior to initiation of androgen deprivation therapy (ADT).

RADIATION

Stereotactic Body Radiation Therapy (SBRT)

Patients will receive standard of care radiation therapy (SBRT)

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Telix Pharmaceuticals

    collaborator UNKNOWN

  • Weill Medical College of Cornell University

    lead OTHER

Principal Investigators

  • Silvia Formenti, M.D. · Weill Medical College of Cornell University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
90 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-30
Primary Completion
2027-12-31
Completion
2027-12-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04402151 on ClinicalTrials.gov