RecruitingPhase 2NCT04402151

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

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

Sponsor

Weill Medical College of Cornell University

Enrollment

50 participants

Start Date

Jun 30, 2020

Study Type

INTERVENTIONAL

Conditions

Prostate Cancer

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.

Eligibility

Sex: MALEMin Age: 21 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This study uses a specialized type of PET scan combined with MRI to get a more detailed picture of prostate cancer before delivering a very precise form of radiation treatment (SBRT). The goal is to see whether this high-tech imaging can improve treatment accuracy for high-risk prostate cancer. **You may be eligible if...** - You are male and at least 21 years old - You have been diagnosed with high-risk or unfavorable intermediate-risk prostate cancer - Your cancer has not spread to other parts of the body - You are willing to use contraception for 7 days after each PSMA scan injection **You may NOT be eligible if...** - You have had a prior prostate surgery called TURP, or your prostate is very large, or your urinary symptoms are severe - You have previously had radiation to the prostate - You are currently taking or plan to take a drug called abiraterone - You have contraindications to the PSMA imaging agent or MRI Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPSMA 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).

RADIATIONStereotactic Body Radiation Therapy (SBRT)

Patients will receive standard of care radiation therapy (SBRT)