Summary

Eligibility
for males ages 18 years and up (full criteria)
Location
at San Francisco, California
Dates
study started
estimated completion
Principal Investigator
Rahul Aggarwahl

Description

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.

Official Title

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

Details

Participants with advanced prostate cancer will be enrolled in parallel in one of two cohorts prospectively determined by the Principal Investigator. Both cohorts will receive up to two 13C pyruvate (C-1 and C-2 labeled 13C pyruvate) injections on the day of imaging (2nd injection is optional) and may choose to undergo 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. When receiving two HP 13C pyruvate injections, the injections will be separated by a period of 15-60 minutes.

Participants in cohort A will undergo MR imaging with hyperpolarized 13C pyruvate of a pre-selected target lesion at a single time point. Participants in cohort B will undergo hyperpolarized 13C pyruvate MRI at baseline and 8 weeks (+/- 4 weeks) following initiation of a line of systemic therapy for the treatment of advanced prostate cancer and may undergo an additional optional MR scan at the time of disease progression as defined by the Prostate Cancer Clinical Trials Working Group 3 (PCWG3). The same sequence of injections will be used for all time points in cohort B.

Keywords

Prostate Cancer Advanced Prostate Carcinoma Hyperpolarized Pyruvate (13C) Prostatic Neoplasms Hyperpolarized C13 Magnetic Resonance Imaging (MRI)

Eligibility

You can join if…

Open to males ages 18 years and up

  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. A minimum of 50% of participants in each cohort must have a metastatic target lesion.
  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:
  3. Soft tissue/visceral organ target lesions must measure at 1 cm in long axis diameter on CT or MRI.
  4. Target lesions in the bone must be visualized by CT or MRI (lesions present only on bone scan do not qualify).
  5. For patients with target lesion in prostate/prostatic bed:
  6. 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.

  1. Cohort B participants only: Must not have started on next line of systemic therapy for the treatment of prostate cancer prior to baseline MRI.
  2. Able and willing to comply with study procedures and provide signed and dated informed consent.
  3. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  4. For patients undergoing optional tumor biopsy:
  5. No history of bleeding diathesis.
  6. Patients on anti-coagulation they must be able to safely stop treatment for purposes of tumor biopsy.

You CAN'T join if...

  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

Location

  • University of California, San Francisco accepting new patients
    San Francisco California 94143 United States

Lead Scientist at UCSF

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Rahul Aggarwal
ID
NCT04346225
Phase
Phase 2
Study Type
Interventional
Last Updated