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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.

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

PSMA SBRT-SIB Trial 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.Check my eligibility

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.See study design

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.

PSMA SBRT-SIB Trial 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.

PSMA SBRT-SIB Trial 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

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

Primary outcome 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 survival

Secondary outcome measures

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

+6 more

PSMA SBRT-SIB 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

~740

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,665 Previous Clinical Trials

40,925,804 Total Patients Enrolled

560 Trials studying Prostate Cancer

507,045 Patients Enrolled for Prostate Cancer

Weill Medical College of Cornell UniversityLead Sponsor

1,055 Previous Clinical Trials

1,316,245 Total Patients Enrolled

48 Trials studying Prostate Cancer

35,589 Patients Enrolled for Prostate Cancer

Josephine Kang, M.D.,Ph.D.Principal InvestigatorWeill Medical College of Cornell University

1 Previous Clinical Trials

22 Total Patients Enrolled

Media Library

Gallium-68 labeled PSMA-HBED-CC (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04402151 — Phase 2

Prostate Cancer Research Study Groups: Single Arm

Prostate Cancer Clinical Trial 2023: Gallium-68 labeled PSMA-HBED-CC Highlights & Side Effects. Trial Name: NCT04402151 — Phase 2

Gallium-68 labeled PSMA-HBED-CC (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04402151 — Phase 2

Frequently Asked Questions

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

How many individuals have been accepted to participate in this investigation?

"Verified. According to clinicaltrials.gov, recruitment is ongoing for this research project which was initially posted on June 30th 2020 and updated lastly on April 10th 2022. 50 participants are being recruited from a single site."

Answered by AI

Is there an age restriction for participants in this medical experiment?

"Only adults aged between 21 and 90 are eligible to take part in this medical trial."

Answered by AI

Are there still vacancies for participants in this research?

"Yes, the online record indicates that this clinical study is actively searching for participants. First posted on June 30th 2020, it was last revised on April 10th 2022 and aims to include 50 individuals at 1 medical centre."

Answered by AI

What evidence exists to suggest the security of this therapy for patients?

"Since this is a Phase 2 clinical trial, there is limited evidence to support the safety of the intervention. We have assigned it an estimated score of 2 on our 1-3 scale."

Answered by AI

Is there an opportunity for me to enlist in this research endeavor?

"The current enrollment process calls for 50 male participants, aged 21 years or older, with a diagnosis of prostate cancer. The upper age limit is 90."

Answered by AI

What other medical trials have been conducted that involve this intervention?

"Currently, 7 separate clinical trials are looking into this therapeutic intervention. Of these investigations, 2 have progressed to the Phase 3 level of study. Although all studies originate from Iowa City, Iowa, they span across a total of 7 different sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2020. "Study of PSMA PET/MR Guided Stereotactic Body Radiation Therapy With Simultaneous Integrated Boost (SBRT-SIB) for High-Intermediate and High Risk Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04402151.

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