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Virus Therapy
Part 3: SBRT participants at time of biochemical recurrence (BCR) for Prostate Cancer
Phase 2
Waitlist Available
Research Sponsored by Robert Bok, MD, PhD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) performance status <= 1
Age >= 18 years old at time of study entry
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights
Study Summary
"This trial is studying how hyperpolarized 13C-pyruvate and 15N-urea metabolic MR imaging can help in assessing prostate cancer patients who have undergone or are currently
Who is the study for?
Men with prostate cancer who are currently receiving or have completed radiation therapy can join this trial. Specific details about inclusion and exclusion criteria were not provided, so it's important to consult the study team for more detailed eligibility requirements.Check my eligibility
What is being tested?
The trial is testing a new type of MRI scan using hyperpolarized pyruvate (13C) and possibly urea (13C,15N) to see how well it shows prostate cancer activity during or after radiotherapy. It also includes standard treatments like SBRT, mpMRI, biopsies, and hormone therapy.See study design
What are the potential side effects?
Potential side effects weren't specified but may include discomfort from the MRI procedure or reactions related to the contrast agents used in imaging. Standard treatment side effects could apply as well.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or can carry out light work.
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I am 18 years old or older.
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My prostate cancer was confirmed by a biopsy.
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My blood and kidney functions are within the required ranges.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Mean HP 13C-pyruvate to glutamate metabolic rate of conversion (kPG) over time (Part 2A)
Mean HP 13C-pyruvate to lactate metabolic rate of conversion (kPL) over time (Part 2A)
Mean change in on-treatment kPG over time (Part 2B)
+4 moreSecondary outcome measures
Correlation of kPG with PI-RADS version 2 classification score
Correlation of kPL with Prostate Imaging Reporting and Data System (PI-RADS) version 2 classification score
Intra-patient variability of kPG
+5 moreTrial Design
4Treatment groups
Experimental Treatment
Group I: Part 3: SBRT participants at time of biochemical recurrence (BCR)Experimental Treatment4 Interventions
Evaluable SBRT participants who undergo HP Pyruvate +/-Urea mpMRI at time of biochemical failure, followed by magnetic resonance (MR) / ultrasound (US) fusion-guided prostate biopsy within 12 weeks following baseline MR exam. Participants in this group have the option of undergoing a follow up HP Pyruvate +/-Urea MR exam 6-15 months following the baseline scan, to evaluate for any interval change.
Group II: Part 2B: Prospective imaging (High-risk localized prostate cancer)Experimental Treatment4 Interventions
Participants with with high-risk localized prostate cancer and have pre-planned, non-interventional primary radiation therapy (RT) with concurrent, systemic, non-interventional hormone therapy will undergo HP Pyruvate+/-Urea mpMRI at baseline prior to the start of systemic hormone therapy, 4-12 weeks after the initiation of systemic hormone therapy (prior to radiation therapy), at 3 months post-radiation therapy, and at +1yr post-radiation therapy.
Group III: Part 2A: Prospective imaging (Stereotactic body radiotherapy (SBRT) Participants)Experimental Treatment3 Interventions
Participants with pre-planned, non-interventional stereotactic body radiotherapy (SBRT) will undergo an HP Pyruvate +/-Urea mpMRI exam at baseline, at 3 months post-SBRT treatment and at 1yr post-treatment.
Group IV: Part 1: Image Optimization GroupExperimental Treatment2 Interventions
Participants will undergo Hyperpolarized 13C-Pyruvate +/- 13C,15N-Urea imaging as part of a multi-parametric magnetic resonance imaging (mpMRI) exam, with the primary objective of optimizing imaging sequences and techniques to maximize signal-to-noise ratio of imaging modality.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radiotherapy (RT)
2017
Completed Phase 2
~110
Find a Location
Who is running the clinical trial?
Robert Bok, MD, PhDLead Sponsor
2 Previous Clinical Trials
105 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,708 Previous Clinical Trials
40,932,568 Total Patients Enrolled
563 Trials studying Prostate Cancer
508,903 Patients Enrolled for Prostate Cancer
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the level of risk associated with Part 3: SBRT participants at the moment when biochemical recurrence (BCR) occurs in individuals?
"The safety evaluation for Part 3 of the SBRT trial at the time of biochemical recurrence (BCR) has been assigned a rating of 2 by our team. This assessment is based on existing safety data, although there is currently no evidence supporting efficacy in this Phase 2 study."
Answered by AI
Is the enrollment phase of this medical study currently accepting participants?
"Information available on clinicaltrials.gov indicates that the investigation is not actively seeking participants. The trial was originally listed on June 1, 2024, with the most recent update made on April 25, 2024. Although this particular study is not recruiting subjects presently, it's noteworthy that there are currently 1387 other trials actively seeking eligible candidates for participation."
Answered by AI
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