Using advanced imaging to detect high-grade prostate cancer

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 pilot clinical trial evaluates the effectiveness of magnetic resonance spectroscopic imaging (MRSI) with hyperpolarized carbon 13 (13C) pyruvate and 13C 15N2 urea in identifying high-grade localized prostate cancer. The study aims to correlate the conversion of hyperpolarized pyruvate to lactate and urea perfusion with the histologic grade of prostate cancer. Participants will undergo imaging procedures prior to planned radical prostatectomy or biopsy, allowing for a comparison of imaging results with histological findings. The study also assesses the safety and reproducibility of these imaging techniques.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Biopsy-proven adenocarcinoma of the prostate. Biopsy may be performed outside of University of California, San Francisco (UCSF), if detailed results of sextant biopsy are available. For Cohort A only, a minimum of 20 participants out of a planned enrollment of 50 patients must have high-risk disease as defined by primary Gleason score of 4 or 5 on prior prostate biopsy.
* Cohort A only: Planned radical prostatectomy at UCSF within 12 weeks following protocol MRI/MRSI.
* Cohort B only: HIFU focal therapy completed within 18 months of protocol MRI/MRSI, and planned systematic and MR-guided biopsy at UCSF within 12 weeks following protocol MRI/MRSI.
* The participant 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

Exclusion Criteria:

* Participants who because of age less than 18 years old, general medical or psychiatric condition, or physiologic status cannot give valid informed consent.
* Participants unwilling or unable to undergo MR imaging, including patients with contraindications to MRI, such as cardiac pacemakers or non-compatible intracranial vascular clips.
* Participants who cannot tolerate or have contra-indications to endorectal coil insertion; for example, participants with a prior abdominoperineal resection of the rectum or latex allergy.

Note: The use of an endorectal coil may be waived at the discretion of the Principal Investigator upon review of available imaging with radiology, in which case this exclusion criterion will not apply.

* Patients with contra-indications to injection of gadolinium contrast; for example patients with prior documented allergy or those with inadequate renal function.
* Metallic hip implant or any other metallic implant or device that distorts local magnetic field and compromises the quality of MR imaging.
* Cryosurgery, surgery for prostate cancer, prostatic or pelvic radiotherapy prior to study enrollment. For Cohort B, HIFU focal therapy is allowed. No limit on number of prior prostate biopsies; prior transurethral prostatic resection (TURP) is not allowed.
* Current or prior androgen deprivation therapy. For Cohort A, a history of use of a 5-alpha reductase inhibitor is allowed, provided it was discontinued at least one month prior to study entry. For cohort B, a history of use of 5-α reductase inhibitor is allowed, provided it is discontinued at least 14 days to protocol MRI/MRSI.
* Poorly controlled hypertension, with blood pressure at study entry \> 160/100; the addition of anti-hypertensives to control blood pressure is allowed for eligibility determination.
* Congestive heart failure or New York Heart Association (NYHA) status \>= 2.
* A history of clinically significant electrocardiography (EKG) abnormalities, including QT prolongation, a family history of prolonged QT interval syndrome, or myocardial infarction (MI) within 6 months of study entry; patients with rate-controlled atrial fibrillation/flutter will be allowed on study.

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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  Recruiting Phase 2 Mayo Clinic · Rochester, Minnesota · NCT07650240

• MRI-based microboost SBRT with de-escalated whole-gland radiation for localized prostate cancer

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• Short-term hormone therapy with PSMA PET/CT before prostate removal for high-risk localized prostate cancer

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• Two-fraction radiotherapy for localized prostate cancer

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  Recruiting UMC Utrecht · Utrecht · NCT06518226

• Using PSMA PET scans to improve prostate cancer treatment accuracy

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  Recruiting at 4 sites Phase 2 University of Alberta · Calgary, Alberta and 3 other locations · NCT06003556

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.