What is CAPTAIN?

CAPTAIN is a randomized controlled trial (RCT) comparing the efficacy and safety of two different treatment options, Radical Prostatectomy (RP) and the TULSA Procedure, for men with intermediate-risk prostate cancer.

Primary Objectives

To determine if the TULSA Procedure is superior to RP for safety by comparing the preservation of erectile potency & urinary continence at 1 year.
To determine if the TULSA Procedure is not inferior to RP for efficacy by comparing the rate of salvage treatment at 3 years.

The Procedures

About Radical Prostatectomy (RP)

Patients randomized to radical prostatectomy arm will receive radical prostatectomy performed as per standard clinical practice at your site, with no restriction on approach. Radical Prostatectomy is a procedure that involves the surgical removal of the prostate and some tissue around it. For men with localized, intermediate-risk prostate cancer, RP is recommended in the national guidelines to be a standard-of-care treatment and has been proven in large randomized controlled trials to reduce the long-term risk of dying from prostate cancer.

About the TULSA Procedure

The Transurethral Ultrasound Ablation (TULSA) Procedure uses directional thermal ultrasound to ablate diseased prostate tissue. It has been demonstrated to be effective at ablating prostate tissue in men with localized, intermediate-risk prostate cancer. The TULSA Procedure is performed in a Magnetic Resonance Imaging (MRI) suite and uses the TULSA-PRO® system to ablate prostate tissue from the ‘inside-out’ (from inside the urethra heating outwards to the edge of the prostate). The TULSA Procedure is cleared for use by the United States Food and Drug Administration (FDA), and Health Canada.

Refer A Patient to a Participating Center

Refer a patient to a study site

Why get involved?

Level 1 evidence comparing emerging modalities for prostate ablation with standard of care therapies is lacking. The TULSA Procedure may provide a safer treatment option than radical prostatectomy for men with prostate cancer if proven in a head-to-head comparison. The CAPTAIN RCT will provide game-changing evidence that may define a less invasive treatment option for men with intermediate-risk prostate cancer.

How to get involved?

Refer Patients to a Study Site
Become Study Site. CAPTAIN is currently enrolling both academic and private practice sites, and is expanding the network of study sites, sub-investigators, and referring physicians.

Become a Study Site

Download Brochure Here

Clinical Evidence

Study Physicians

References

1. Ficarra V, Novara G, Rosen RC, et al. Systematic review and meta-analysis of studies reporting urinary continence recovery after robot-assisted radical prostatectomy. Eur Urol 2012; 62:405-417.
2. Klotz L, Pavlovich CP, Chin J, et al. Magnetic resonance imaging-guided transurethral ultrasound ablation of prostate cancer. J Urol 2021; 205:769-779.
3. Chin J, Billia M, Relle J, et al. Magnetic resonance imaging–guided transurethral ultrasound ablation of prostate tissue in patients with localized prostate cancer: A Prospective Phase 1 Clinical Trial. Eur Urol 2016; 70:447-455.
4. Lane JA, Donovan JL, Young GJ, et al. Functional and quality of life outcomes of localised prostate cancer treatments (Prostate Testing for Cancer and Treatment [ProtecT] study). BJU Int 2022; 130:370-380.
5. Hoffman KE, Penson DF, Zhao Z, et al. Patient-reported outcomes through 5 years for active surveillance, surgery, brachytherapy, or external beam radiation with or without androgen deprivation therapy for localized prostate cancer. JAMA 2020; 323:149-163.
6. Klotz L, Pavlovich CP, Chin J, et al. MP46-03: Pivotal trial of MRI-guided transurethral ultrasound ablation in men with localized prostate cancer: Three-year follow-up. J Urol 2021; 206:e814.
7. Albisinni S, Aoun F, Bellucci S, et al. Comparing high-intensity focal ultrasound hemiablation to robotic radical prostatectomy in the management of unilateral prostate cancer: A Matched-Pair Analysis. J Endourology 2017; 31:14-19.
8. Shah, T.T., Reddy, D., Peters, M. et al. Focal therapy compared to radical prostatectomy for non-metastatic prostate cancer: a propensity score-matched study. Prostate Cancer Prostatic Dis 2021; 24:567–574.
9. van Son, M.J., Peters, M., Reddy, D. et al. Conventional radical versus focal treatment for localised prostate cancer: a propensity score weighted comparison of 6-year tumour control. Prostate Cancer Prostatic Dis 2021; 24:1120–1128.