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Study of PSMA PET/MR Guided SBRT for High-Risk Prostate Cancer

This study is looking at a new way to treat high-intermediate and high-risk prostate cancer using a special type of radiation called Stereotactic Body Radiation Therapy (SBRT). Before treatment, you would receive an IV injection of Gallium-68 labeled PSMA-HBED-CC (a tracer) for a PSMA PET/MR scan. This scan helps doctors see the cancer more clearly. The study aims to see if using this advanced imaging to guide SBRT can improve how long patients live without their cancer coming back. We are looking for men aged 21 to 90 with confirmed high-risk prostate cancer. The study's status is currently unclear.

Study design
This is a single-arm study, meaning all participants receive the same treatment. It plans to enroll 50 participants.
What's involved
You would undergo a PSMA PET/MR scan before radiation planning and then receive standard SBRT radiation therapy.
Compensation
Not stated in the trial record.
Follow-up
The study will assess recurrence-free survival at 24 months after treatment.

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NCT04402151

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

Recruiting
PHASE2Ages 21–90InterventionalTreatment
Weill Medical College of Cornell University
~50 participants
Updated 2026-01-26 on ClinicalTrials.gov
What's tested:PSMA PET/MR - Gallium-68 labeled PSMA-HBED-CCStereotactic Body Radiation Therapy (SBRT)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Clinical efficacy of prostate-specific membrane antigen (PSMA) Positron Emission Tomography (PET)/Magnetic Resonance(MR), MR-Linear Accelerator (LINAC) will be assessed by evaluating recurrence free survival
Measured over 24 months

Conditions

Prostate Cancer

Explore related trials

Prostate Carcinoma

Where it's being run

1 sites across 1 states
New York1

Study leadership

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

Who to contact

Fabiana Gregucci, M.D.
[email protected]
646-962-3110
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Eligibility criteria

Inclusion

Male aged 21 years or older.
Ability to provide signed informed consent and willingness to comply with protocol requirements.
Pathologic confirmation of high-risk adenocarcinoma of the prostate gland as follows: a. Gleason 8-10 or tertiary component 5 disease and/or b. PSA of 20 ng/ml or greater and/or c. Tumor stage of T2c or greater; OR Unfavorable intermediate risk (Gleason 4+3=7, \>50% of cores involved, or 2 or more intermediate risk factors which include Gleason 7 disease, PSA 10-20, or T2b disease)
Participants must agree to use an acceptable form of birth control and utilize condoms for a period of seven days after each PSMA injection, if engaged in sexual activity.
No evidence of metastatic disease, including pelvic lymph nodes.

Exclusion

Clinical and/or technical factors that would compromise statistical analysis of the PET and/or MR.
Contraindications to PSMA IV administration
Contraindications to prostate SBRT (history of transurethral resection of prostate; prostate size greater than 150 cc; AUA score greater than 20; history of prior radiation to the prostate)
Other unspecified reasons that, in the opinion of investigators, make the subject unsuitable for enrollment
Patients on or intending to take abiraterone will be excluded

What this trial measures

  • Clinical efficacy of prostate-specific membrane antigen (PSMA) Positron Emission Tomography (PET)/Magnetic Resonance(MR), MR-Linear Accelerator (LINAC) will be assessed by evaluating recurrence free survival24 months

    Evaluate the clinical efficacy of PSMA PET/MR guided, MR-LINAC-based SBRT- SIB in high-intermediate and high risk prostate cancer, as evaluated by the 2-year recurrence-free survival rate