Monitoring prostate cancer with advanced MRI techniques

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase II trial evaluates the effectiveness of hyperpolarized carbon C-13 pyruvate magnetic resonance imaging (MRI) in monitoring patients with prostate cancer who are on active surveillance. The study aims to optimize imaging sequences to enhance the visualization of tumor metabolism and assess the relationship between imaging results and biopsy outcomes. Participants will undergo MRI scans to measure the uptake and breakdown of pyruvate in tumor cells compared to benign tissue, with follow-up biopsies planned to correlate imaging findings with Gleason grades. The study also explores the safety profile of the imaging agent and its potential to improve monitoring strategies for prostate cancer.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* The subject has biopsy-proven adenocarcinoma of the prostate with low to intermediate risk disease by UCSF-CAPRA scoring at study entry.
* For Part 1: Patient planning to enroll or currently on active surveillance; For Part 2: Currently enrolled on active surveillance with planned fusion biopsy within 12 weeks following completion of baseline HP C-13 pyruvate/mpMRI on study.
* The subject is 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.
* Absolute neutrophil count (ANC) \>= 1000 cells/microliter (uL).
* Hemoglobin \>= 9.0 gm/deciliter (dL).
* Platelets \>= 75,000 cells/uL.
* Estimated creatinine clearance\* \>= 50 milliliter (mL)/min by the Cockcroft Gault equation.
* Total bilirubin =\< 1.5 x upper limit of normal (ULN) or if =\< 3 x ULN if known/suspected Gilbert's
* Aspartate aminotransferase (AST) =\< 1.5 x ULN.
* Alanine aminotransferase (ALT) =\< 1.5 x ULN.

Exclusion Criteria:

* Patients without evidence of any prostate cancer on most recent prostate biopsy performed prior to study entry.
* Current or prior androgen deprivation therapy including luteinizing hormone-releasing hormone (LHRH) analogue or oral anti-androgen therapy. Previous use of a 5-alpha reductase inhibitor is allowed, provided it was discontinued at least 28 days prior to baseline C-13 HP pyruvate MRI
* Prior radiation treatment of the prostate.
* Prostate biopsy performed within 14 days prior to baseline C-13 HP pyruvate MRI.
* Poorly controlled hypertension, with blood pressure at study entry \> 160 mm Hg systolic or \> 100 mmg Hg diastolic. Treatment with anti-hypertensives and re-screening is permitted.
* Congestive heart failure with New York Heart Association (NYHA) status \>= 2.

Where it's running

• 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: Louise Magat
• Email: Louise.Magat@ucsf.edu
• Phone: (415) 502-1822

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Radiation therapy for recurrent prostate cancer

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.