Using MRI with Hyperpolarized Pyruvate to Diagnose Advanced Prostate Cancer
Magnetic Resonance (MR) Imaging With Hyperpolarized Pyruvate (13C) as a Diagnostic and Response Monitoring Imaging Tool in Advanced Prostate Cancer
This study is testing if a special type of MRI using a new substance can help doctors better diagnose and monitor treatment for patients with advanced prostate cancer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | University of California, San Francisco Academic / other |
| Locations | 1 site (San Francisco, California) |
| Trial ID | NCT04346225 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of metabolic magnetic resonance imaging (MRI) using hyperpolarized carbon-13 pyruvate as a diagnostic tool for patients with advanced prostate cancer. The study aims to measure metabolic fluxes within tumors and assess changes in these measurements over time to monitor treatment response. It includes both primary and secondary objectives focused on understanding intra-tumoral heterogeneity and correlating metabolic changes with clinical outcomes. The trial is designed to extend preliminary findings and further develop this imaging technique for clinical use.
Who should consider this trial
Good fit: Ideal candidates are patients with histologically-confirmed locally advanced or metastatic prostate cancer who have measurable target lesions.
Not a fit: Patients with prostate cancer who have had prior local treatment to the selected lesion or those without measurable target lesions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a non-invasive method to better diagnose and monitor treatment responses in advanced prostate cancer patients.
How similar studies have performed: Preliminary studies have shown promise in using hyperpolarized carbon-13 MRI for detecting high-grade prostate cancer, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Histologically-confirmed locally advanced or metastatic prostate cancer. Patients with unequivocal clinical evidence supporting diagnosis of prostate cancer who have not had prior biopsy may be considered eligible per judgment of Principal Investigator. 2. Presence of at least one target lesion detected by standard staging scans that, in the judgment of Study Investigators, would be amenable to hyperpolarized C-13 pyruvate/metabolic MR imaging: 1. Soft tissue/visceral organ target lesions must measure at 1 cm in long axis diameter on CT or MRI. 2. Target lesions in the bone must be visualized by CT or MRI (lesions present only on bone scan do not qualify). 3. For patients with target lesion in prostate/prostatic bed: i. No contra-indications to endorectal coil insertion (e.g., patients with a prior abdominoperineal resection of the rectum or latex allergy). ii. No prior local treatment to the selected lesion, or evidence of radiographic progression following prior local therapy to selected lesion. 3. Able and willing to comply with study procedures and provide signed and dated informed consent. 4. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 5. For patients undergoing optional tumor biopsy: 1. No history of bleeding diathesis. 2. Patients on anti-coagulation they must be able to safely stop treatment for purposes of tumor biopsy. Exclusion Criteria: 1. Patients who because of age, general medical or psychiatric condition, or physiologic status cannot give valid informed consent. 2. Patients unwilling or unable to undergo MR imaging, including patients with contra- indications to MRI, such as cardiac pacemakers or non-compatible intracranial vascular clips. 3. Metallic hip implant or any other metallic implant or device that distorts local magnetic field and compromises the quality of MRI. 4. Any condition that, in the opinion of the Principal Investigator, would impair the patient's ability to comply with study procedures
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: Maya Aslam
- Email: Maya.Aslam@ucsf.edu
- Phone: 877-827-3222
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.