Condition: Prostate Cancer, Localized Prostate Carcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02526368

Sponsor: Ivan de Kouchkovsky, MD

Phase: Early Phase 1

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: Male

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
• Absolute neutrophil count (ANC) >= 1500 cells/microliter (uL)
• Hemoglobin >= 9.0 mg/dL
• Platelets >= 75,000 cells/uL
• Estimated creatinine clearance >= 50 mL/min (by the Cockcroft Gault equation)
• Bilirubin < 1.5 x upper limit of normal (ULN) (unless Gilbert's is suspected)
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 1.5 x ULN

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.
• 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.

View trial on ClinicalTrials.gov