Magnetic Resonance (MR) Imaging With Hyperpolarized Pyruvate (13C) as a Diagnostic and Response Monitoring Imaging Tool in Advanced Prostate Cancer

Who is this study for? Patients with Prostate Cancer
What treatments are being studied? Hyperpolarized C13+Magnetic Resonance Imaging (MRI)
Status: Recruiting
Location: See location...
Intervention Type: Procedure, Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This is a prospective imaging study evaluating the utility of baseline metabolic MR imaging as a diagnostic and response monitoring tool in patients with advanced prostate cancer. Preliminary pre-clinical and clinical data demonstrates the ability of HP C-13 pyruvate/metabolic MR imaging to detect high-grade prostate cancer, including cancer with neuroendocrine differentiation, as well as provide early evidence of metabolic response and resistance following application of systemic therapies for the treatment of advanced prostate cancer patients. In the proposed study, the investigators aim is to extend the initial clinical results and further develop HP C-13 MRI as an imaging modality in advanced prostate cancer.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

• 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:

‣ Soft tissue/visceral organ target lesions must measure at 1 cm in long axis diameter on CT or MRI.

⁃ Target lesions in the bone must be visualized by CT or MRI (lesions present only on bone scan do not qualify).

⁃ 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.

• 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

• For patients undergoing optional tumor biopsy:

‣ No history of bleeding diathesis.

⁃ Patients on anti-coagulation they must be able to safely stop treatment for purposes of tumor biopsy.

Locations
United States
California
University of California, San Francisco
RECRUITING
San Francisco
Contact Information
Primary
Maya Aslam
Maya.Aslam@ucsf.edu
877-827-3222
Time Frame
Start Date: 2020-07-16
Estimated Completion Date: 2026-11-30
Participants
Target number of participants: 75
Treatments
Experimental: Cohort A: Hyperpolarized C13 MRI at a single time point
Participants will undergo MR imaging with hyperpolarized 13C pyruvate of a pre-selected target lesion at a single time point and will receive up to two 13C pyruvate (C-1 and C-2 labeled 13C pyruvate) investigational medicinal product (IMP) injections on the day of imaging (2nd injection is optional), as well as optional MR- or CT- guided tumor biopsies at baseline and at the time of disease progression following completion of HP C-13 MRI at the corresponding time point
Experimental: Cohort B: Hyperpolarized C13 MRI at multiple time points
Participants will undergo hyperpolarized (HP) C13 MRI at baseline and 12 weeks (+/- 8 weeks). Participants in Cohort B may undergo additional optional MR imaging at the time of disease progression. the same sequence of injections (C-1 labeled pyruvate first, C-2 labeled pyruvate second) will be used for subsequent scan time points as well.
Authors
Rahul Aggarwahl
Related Therapeutic Areas
Sponsors
Collaborators: National Institute for Biomedical Imaging and Bioengineering (NIBIB), National Cancer Institute (NCI)
Leads: Ivan de Kouchkovsky, MD

This content was sourced from clinicaltrials.gov