A Comparison of TULSA Procedure vs. Radical Prostatectomy in Participants With Localized Prostate Cancer

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Trial ID: NCT05027477

Age - 40 Years-80 Years Condition - Prostate Cancer, Prostate - Localized Gender - MALE Accepting Healthy Volunteers - No

Purpose

Men with localized, intermediate risk prostate cancer will be randomized to undergo either radical prostatectomy or the TULSA procedure, with a follow-up of 10 years in this multi-centered randomized control trial. This study will determine whether the TULSA procedure is as effective and more safe compared to radical prostatectomy.

Official Title

Customized Ablation of the Prostate With the TULSA Procedure Against Radical Prostatectomy Treatment: a Randomized Controlled Trial for Localized Prostate Cancer (CAPTAIN)

Stanford Investigator(s)

Geoffrey Sonn
Geoffrey Sonn

Associate Professor of Urology and, by courtesy, of Radiology (Body MRI)

Pejman Ghanouni, MD, PhD
Pejman Ghanouni, MD, PhD

Associate Professor of Radiology (Body MRI) and, by courtesy, of Neurosurgery, of Obstetrics and Gynecology and of Urology

Eligibility

Inclusion Criteria:

* Male
* Age 40 to 80 years, with \>10 years life expectancy
* NCCN (favorable and unfavourable) intermediate-risk prostate cancer on biopsy acquired within last 12 months
* Stage ≤cT2c, N0, M0
* ISUP Grade Group 2 or 3 disease on TRUS-guided biopsy or in-bore biopsy
* PSA ≤20ng/mL within last 3 months
* Treatment-naïve
* Planned ablation volume is \< 3 cm axial radius from urethra on mpMRI acquired within last 6 months

Exclusion Criteria:

* Inability to undergo MRI or general anesthesia
* Suspected tumor is \> 30 mm from the prostatic urethra
* Prostate calcifications \> 3 mm in maximum extent obstructing ablation of tumor
* Unresolved urinary tract infection or prostatitis
* History of proctitis, bladder stones, hematuria, history of acute urinary retention, severe neurogenic bladder
* Artificial urinary sphincter, penile implant, or intraprostatic implant
* Patients who are otherwise not deemed candidates for radical prostatectomy
* Inability or unwillingness to provide informed consent
* History of anal or rectal fibrosis or stenosis, or urethral stenosis, or other abnormality challenging insertion of devices

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Intervention(s):

device: Radical Prostatectomy

device: TULSA Procedure

Recruiting

I'm Interested

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Julia Gallagher-Teske
650-723-5543

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