Monitoring prostate cancer with advanced MRI techniques
A Phase 2 Study of Magnetic Resonance (MR) Imaging With Hyperpolarized Pyruvate (13C) in Patients With Prostate Cancer on Active Surveillance
PHASE2 · University of California, San Francisco · NCT03933670
This study is testing a new type of MRI to see if it can better track prostate cancer in patients who are being watched closely and how it relates to their biopsy results.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | University of California, San Francisco (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (San Francisco, California) |
| Trial ID | NCT03933670 on ClinicalTrials.gov |
What this trial studies
This phase II trial evaluates the effectiveness of hyperpolarized carbon C-13 pyruvate magnetic resonance imaging (MRI) in monitoring patients with prostate cancer who are on active surveillance. The study aims to optimize imaging sequences to enhance the visualization of tumor metabolism and assess the relationship between imaging results and biopsy outcomes. Participants will undergo MRI scans to measure the uptake and breakdown of pyruvate in tumor cells compared to benign tissue, with follow-up biopsies planned to correlate imaging findings with Gleason grades. The study also explores the safety profile of the imaging agent and its potential to improve monitoring strategies for prostate cancer.
Who should consider this trial
Good fit: Ideal candidates are men with biopsy-proven low to intermediate risk prostate adenocarcinoma who are currently on active surveillance.
Not a fit: Patients with high-risk prostate cancer or those who have already received treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a non-invasive method to better monitor prostate cancer progression and inform treatment decisions.
How similar studies have performed: Other studies using advanced imaging techniques have shown promise in monitoring cancer, suggesting potential success for this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * The subject has biopsy-proven adenocarcinoma of the prostate with low to intermediate risk disease by UCSF-CAPRA scoring at study entry. * For Part 1: Patient planning to enroll or currently on active surveillance; For Part 2: Currently enrolled on active surveillance with planned fusion biopsy within 12 weeks following completion of baseline HP C-13 pyruvate/mpMRI on study. * The subject is able and willing to comply with study procedures and provide signed and dated informed consent. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Absolute neutrophil count (ANC) \>= 1000 cells/microliter (uL). * Hemoglobin \>= 9.0 gm/deciliter (dL). * Platelets \>= 75,000 cells/uL. * Estimated creatinine clearance\* \>= 50 milliliter (mL)/min by the Cockcroft Gault equation. * Total bilirubin =\< 1.5 x upper limit of normal (ULN) or if =\< 3 x ULN if known/suspected Gilbert's * Aspartate aminotransferase (AST) =\< 1.5 x ULN. * Alanine aminotransferase (ALT) =\< 1.5 x ULN. Exclusion Criteria: * Patients without evidence of any prostate cancer on most recent prostate biopsy performed prior to study entry. * Current or prior androgen deprivation therapy including luteinizing hormone-releasing hormone (LHRH) analogue or oral anti-androgen therapy. Previous use of a 5-alpha reductase inhibitor is allowed, provided it was discontinued at least 28 days prior to baseline C-13 HP pyruvate MRI * Prior radiation treatment of the prostate. * Prostate biopsy performed within 14 days prior to baseline C-13 HP pyruvate MRI. * Poorly controlled hypertension, with blood pressure at study entry \> 160 mm Hg systolic or \> 100 mmg Hg diastolic. Treatment with anti-hypertensives and re-screening is permitted. * Congestive heart failure with New York Heart Association (NYHA) status \>= 2.
Where this trial is running
San Francisco, California
- University of California, San Francisco — San Francisco, California, United States (RECRUITING)
Study contacts
- Principal investigator: Ivan de Kouchkovsky, MD — University of California, San Francisco
- Study coordinator: Louise Magat
- Email: Louise.Magat@ucsf.edu
- Phone: (415) 502-1822
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Prostate Adenocarcinoma, Prostate Cancer, Imaging