Prostate Cancer Clinical Trial
Official title:
Magnetic Resonance (MR) Imaging With Hyperpolarized Pyruvate (13C) as a Diagnostic and Response Monitoring Imaging Tool in Advanced Prostate Cancer
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.
Status | Recruiting |
Enrollment | 75 |
Est. completion date | November 30, 2026 |
Est. primary completion date | December 31, 2025 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of California, San Francisco | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
Rahul Aggarwal | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | Intra-tumoral range of kPL measurement within target lesion | The mean, standard deviation, and range for intra-tumoral kPG within metastatic lesions will be descriptively reported, to asses for intra-tumoral heterogeneity. | Up to 1 year | |
Secondary | Intra-tumoral range of kPG measurement within target lesion | The mean, standard deviation, and range for intra-tumoral kPG within metastatic lesions will be descriptively reported, to asses for intra-tumoral heterogeneity. | Up to 1 year |
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