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Virus Therapy

SBRT with PSMA PET/MR for Prostate Cancer (PSMA SBRT-SIB Trial)

Phase 2

Recruiting

Led By Josephine Kang, M.D.,Ph.D.

Research Sponsored by Weill Medical College of Cornell University

Eligibility Criteria Checklist

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

Must have

No evidence of metastatic disease, including pelvic lymph nodes.

Male aged 21 years or older.

Must not have

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)

Contraindications to PSMA IV administration

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 1month, 6months, 12 months, 18 months and 24 months.

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new way to treat prostate cancer using MR-LINAC based SBRT-SIB. They hope to enroll 50 patients.

Who is the study for?

Men over 21 with high-risk prostate cancer (Gleason score 8-10, PSA over 20 ng/ml, or advanced tumor stage) or unfavorable intermediate risk. Participants must not have metastatic disease and agree to use birth control after PSMA injections. Exclusions include contraindications to PSMA IV or SBRT, large prostate size, high AUA score, prior radiation treatment to the prostate, abiraterone usage.

What is being tested?

This Phase II trial is testing a targeted radiation therapy guided by PSMA PET/MR imaging in men with high-intermediate and high-risk prostate cancer. The study aims to enroll 50 patients who will receive Stereotactic Body Radiation Therapy (SBRT) with an integrated boost directed by advanced imaging techniques.

What are the potential side effects?

Potential side effects may include discomfort at the injection site from PSMA IV administration, typical radiation therapy side effects like skin irritation near treated areas, fatigue, urinary issues such as increased frequency or urgency and bowel changes.

Eligibility Criteria

Inclusion Criteria

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

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My cancer has not spread to other parts of my body or lymph nodes.

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I am a man aged 21 or older.

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My prostate cancer is aggressive or at an intermediate risk level.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have no medical reasons preventing me from undergoing prostate SBRT.

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I have no health issues preventing me from receiving PSMA IV treatments.

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I am not taking and do not plan to take abiraterone.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 1month, 6months, 12 months, 18 months and 24 months.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 1month, 6months, 12 months, 18 months and 24 months.

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 1month, 6months, 12 months, 18 months and 24 months. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Change in Number of Subjects with Adverse events

Change in Quality of life questionnaires (EPIC-26) will be assessed.

Change in The American Urological Association (AUA) symptom score

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Single ArmExperimental Treatment2 Interventions

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).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Stereotactic Body Radiation Therapy (SBRT)

2018

Completed Phase 2

~950

0 / 6Eligibility criteria met