Magnetic Resonance Imaging (MRI) With Hyperpolarized Pyruvate (13C) as Diagnostic Tool in Advanced Prostate Cancer

NCT04346225 | Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: 20922R01CA215694U01EB026412
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostate Cancer; Advanced Prostate Carcinoma

Keywords

Prostate Cancer; Hyperpolarized Pyruvate (13C)

Outcome Measures

Primary Outcomes (4)

• Pyruvate to lactate (kPL) metabolic flux within target lesion (Cohort A)

  The metabolic flux of kPL within the target lesion will be determined for each participant enrolled in Cohort A. Descriptive statistics will be used to summarize the kPL measurements with the mean, standard deviation, and 95% confidence interval

  1 day

• Pyruvate to glutamate (kPG) metabolic flux within target lesion (Cohort A).

  The metabolic flux of kPG within the target lesion will be determined for each participant enrolled in Cohort A. Descriptive statistics will be used to summarize the kPG measurements with the mean, standard deviation, and 95% confidence interval

  1 day

• Mean percent change from baseline in intra-tumoral kPL within target lesion after treatment. (Cohort B)

  The mean percent change from baseline in intra-tumoral kPL to repeat metabolic MRI obtained at the time of radiographic disease progression by PCWG3 criteria will be descriptively reported for the entire study cohort and for the subgroups of participants with treatment- refractory and treatment-responsive prostate cancer. A paired t-test or signed rank Wilcoxon test will be used to compare follow up versus baseline kPL in target lesion in participants enrolled in Cohort B.

  Up to 8 weeks

• Mean percent change from baseline in intra-tumoral kPG within target lesion after treatment.

  The mean percent change from baseline in intra-tumoral kPG to repeat metabolic MRI obtained at the time of radiographic disease progression by PCWG3 criteria will be descriptively reported for the entire study cohort and for the subgroups of participants with treatment- refractory and treatment-responsive prostate cancer. A paired t-test or signed rank Wilcoxon test will be used to compare follow up versus baseline kPG in target lesion in participants enrolled in Cohort B.

  Up to 8 weeks

Secondary Outcomes (2)

• Intra-tumoral range of kPL measurement within target lesion

  Up to 1 year

• Intra-tumoral range of kPG measurement within target lesion

  Up to 1 year

Study Arms (2)

Cohort A: Hyperpolarized C13 MRI at a single time point

EXPERIMENTAL

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

Drug: Hyperpolarized C13; Procedure: Magnetic Resonance Imaging (MRI)

Cohort B: Hyperpolarized C13 MRI at multiple time points

EXPERIMENTAL

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.

Drug: Hyperpolarized C13; Procedure: Magnetic Resonance Imaging (MRI)

Interventions

Hyperpolarized C13 DRUG

Given by intravenous injection. When receiving two HP 13C pyruvate injections, the injections will be separated by a period of 15-60 minutes

Also known as: HP [1-13C]pyruvate

Cohort A: Hyperpolarized C13 MRI at a single time point; Cohort B: Hyperpolarized C13 MRI at multiple time points

Magnetic Resonance Imaging (MRI) PROCEDURE

Magnetic resonance imaging (MRI) is a medical imaging technique that uses a magnetic field and computer-generated radio waves to create detailed images of the organs and tissues in your body

Also known as: Magnetic Resonance

Cohort A: Hyperpolarized C13 MRI at a single time point; Cohort B: Hyperpolarized C13 MRI at multiple time points

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients who because of age, general medical or psychiatric condition, or physiologic status cannot give valid informed consent.
• 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.
• Metallic hip implant or any other metallic implant or device that distorts local magnetic field and compromises the quality of MRI.
• Any condition that, in the opinion of the Principal Investigator, would impair the patient's ability to comply with study procedures

Sponsors & Collaborators

• Ivan de Kouchkovsky, MD: lead
• National Cancer Institute (NCI): collaborator
• National Institute for Biomedical Imaging and Bioengineering (NIBIB): collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Ivan de Kouchkovsky, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maya Aslam

CONTACT

877-827-3222; Maya.Aslam@ucsf.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 10, 2020
• First Posted: April 15, 2020
• Study Start: July 16, 2020
• Primary Completion: December 31, 2025
• Study Completion (Estimated): November 30, 2026
• Last Updated: July 3, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)