No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Male
Trial phase
Early Phase 1
Study type
Interventional
Purpose
Diagnostic
Participants needed
80 (estimated)
Sponsor
Ivan de Kouchkovsky, MD · Other
Who this trial is looking for
This trial is looking for men with prostate cancer that has not spread. Participants will undergo special MRI imaging to help detect their cancer more accurately.
Are You a Good Fit for This Trial?
Must not be takingAndrogen deprivation therapy5-alpha reductase inhibitor
Rules you outCongestive heart failureSignificant heart diseaseQT prolongation
You may be able to join if
I have been diagnosed with adenocarcinoma of the prostate.
I can give my consent to take part in this study.
I have a planned surgical procedure for my cancer within 12 weeks.
I have high-risk disease as defined by my biopsy results.
I have completed specific prior therapies within the required time.
I have an ECOG performance status of 0 or 1.
You may not be able to join if
I am under 18 years old.
I cannot undergo MRI for any medical reasons.
I cannot tolerate or have allergies related to the study procedures.
I have serious heart problems or hypertension above certain levels.
I have had recent heart surgery or significant heart conditions.
I have had prior surgeries or radiotherapy for prostate cancer.
I cannot take MRI contrast due to allergies or kidney issues.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
This pilot clinical trial studies how well magnetic resonance spectroscopic imaging (MRSI) with hyperpolarized carbon 13 (13C) pyruvate alone or in combination with 13C 15N2 Urea works in finding prostate cancer that exhibits poorly differentiated or undifferentiated cells (high-grade) and that is restricted to the site of origin, without evidence of spread (localized) in patients undergoing radic…
This pilot clinical trial studies how well magnetic resonance spectroscopic imaging (MRSI) with hyperpolarized carbon 13 (13C) pyruvate alone or in combination with 13C 15N2 Urea works in finding prostate cancer that exhibits poorly differentiated or undifferentiated cells (high-grade) and that is restricted to the site of origin, without evidence of spread (localized) in patients undergoing radical prostatectomy. Diagnostic procedures, such as MRSI with hyperpolarized carbon (13C) pyruvate, may aid in the diagnosis of prostate cancer and in discriminating high-grade from low-grade prostate cancer and benign adjacent prostate tissue
Trial Locations
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Status
Eligibility Criteria
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…
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.
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