Randomized Trial of HIFU vs. Cryo for Prostate Cancer

NCT06929065 | Completed

• 1 other identifier: KPFT
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

HIFU has been FDA approved and is widely utilized across the United States and Europe for the treatment of prostate cancer. Despite this, HIFU has not been offered within SCPMG until now due to growing patient demand. We have offered cryoablation. This pilot study will determine the efficacy of HIFU vs. cryoablation focal therapy for early stage prostate cancer within SCPMG. We hope to elucidate whether outcomes are similar between the two modalities.

Conditions

Prostate Cancer; Prostate Cancer Stage I; Prostate Cancer Stage II; High Intensity Focused Ultrasound; HIFU; Cryoablation

Outcome Measures

Primary Outcomes (1)

• In-field cancer persistence

  MRI and biopsy results

  3 months

Secondary Outcomes (4)

• AUAss change from baseline

  month 3, month 6, month 12, month 24

• IIEF change from baseline

  month 3, month 6, month 12, month 24

• Complications and satisfaction

  month 3, month 6, month 12, month 24

• PSA

  month 3, month 6, month 12, month 24

Study Arms (2)

HIFU

EXPERIMENTAL

HIFU

Procedure: HIFU vs Cryoablation

Cryoablation

ACTIVE COMPARATOR

Cryo

Procedure: HIFU vs Cryoablation

Interventions

HIFU vs Cryoablation PROCEDURE

HIFU vs cryoablation

Cryoablation; HIFU

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All men age 40 or older with Gleason group 1 or 2 prostate cancer involving a single or adjacent sextants
• PSA \< 10
• mpMRI without extracapsular extension or seminal vesicle invasion (non-focal MRI or organ confined)
• mpMRI which is either nonfocal or concordant with biopsy.

You may not qualify if:

• Gleason group 3 or higher
• Multifocal disease
• mpMRI with ECE or SVI
• PSA \> 10
• Active anorectal disease
• Age \> 80

Sponsors & Collaborators

• Kaiser Permanente: lead

Study Sites (1)

Kaiser Permanente

Los Angeles, California, 90077, United States

Location

Related Publications (11)

• Bakavicius A, Marra G, Macek P, Robertson C, Abreu AL, George AK, Malavaud B, Coloby P, Rischmann P, Moschini M, Rastinehad AR, Sidana A, Stabile A, Tourinho-Barbosa R, de la Rosette J, Ahmed H, Polascik T, Cathelineau X, Sanchez-Salas R. Available evidence on HIFU for focal treatment of prostate cancer: a systematic review. Int Braz J Urol. 2022 Mar-Apr;48(2):263-274. doi: 10.1590/S1677-5538.IBJU.2021.0091.

  PMID: 34003610 BACKGROUND

• Guillaumier S, Peters M, Arya M, Afzal N, Charman S, Dudderidge T, Hosking-Jervis F, Hindley RG, Lewi H, McCartan N, Moore CM, Nigam R, Ogden C, Persad R, Shah K, van der Meulen J, Virdi J, Winkler M, Emberton M, Ahmed HU. A Multicentre Study of 5-year Outcomes Following Focal Therapy in Treating Clinically Significant Nonmetastatic Prostate Cancer. Eur Urol. 2018 Oct;74(4):422-429. doi: 10.1016/j.eururo.2018.06.006. Epub 2018 Jun 28.

  PMID: 29960750 BACKGROUND

• von Hardenberg J, Westhoff N, Baumunk D, Hausmann D, Martini T, Marx A, Porubsky S, Schostak M, Michel MS, Ritter M. Prostate cancer treatment by the latest focal HIFU device with MRI/TRUS-fusion control biopsies: A prospective evaluation. Urol Oncol. 2018 Sep;36(9):401.e1-401.e9. doi: 10.1016/j.urolonc.2018.05.022. Epub 2018 Aug 6.

  PMID: 30093211 BACKGROUND

• Westhoff N, Ernst R, Kowalewski KF, Schmidt L, Worst TS, Michel MS, von Hardenberg J. Treatment decision satisfaction and regret after focal HIFU for localized prostate cancer. World J Urol. 2021 Apr;39(4):1121-1129. doi: 10.1007/s00345-020-03301-0. Epub 2020 Jun 12.

  PMID: 32533247 BACKGROUND

• Lovegrove CE, Peters M, Guillaumier S, Arya M, Afzal N, Dudderidge T, Hosking-Jervis F, Hindley RG, Lewi H, McCartan N, Moore CM, Nigam R, Ogden C, Persad R, Virdi J, Winkler M, Emberton M, Ahmed HU, Shah TT, Minhas S. Evaluation of functional outcomes after a second focal high-intensity focused ultrasonography (HIFU) procedure in men with primary localized, non-metastatic prostate cancer: results from the HIFU Evaluation and Assessment of Treatment (HEAT) registry. BJU Int. 2020 Jun;125(6):853-860. doi: 10.1111/bju.15004. Epub 2020 Feb 11.

  PMID: 31971335 BACKGROUND

• Connor MJ, Gorin MA, Ahmed HU, Nigam R. Focal therapy for localized prostate cancer in the era of routine multi-parametric MRI. Prostate Cancer Prostatic Dis. 2020 Jun;23(2):232-243. doi: 10.1038/s41391-020-0206-6. Epub 2020 Feb 12.

  PMID: 32051551 BACKGROUND

• Biermann K, Montironi R, Lopez-Beltran A, Zhang S, Cheng L. Histopathological findings after treatment of prostate cancer using high-intensity focused ultrasound (HIFU). Prostate. 2010 Aug;70(11):1196-200. doi: 10.1002/pros.21154.

  PMID: 20564422 BACKGROUND

• van Velthoven R, Aoun F, Marcelis Q, Albisinni S, Zanaty M, Lemort M, Peltier A, Limani K. A prospective clinical trial of HIFU hemiablation for clinically localized prostate cancer. Prostate Cancer Prostatic Dis. 2016 Mar;19(1):79-83. doi: 10.1038/pcan.2015.55. Epub 2015 Nov 24.

  PMID: 26597660 BACKGROUND

• Hamdy FC, Elliott D, le Conte S, Davies LC, Burns RM, Thomson C, Gray R, Wolstenholme J, Donovan JL, Fitzpatrick R, Verrill C, Gleeson F, Singh S, Rosario D, Catto JW, Brewster S, Dudderidge T, Hindley R, Emara A, Sooriakumaran P, Ahmed HU, Leslie TA. Partial ablation versus radical prostatectomy in intermediate-risk prostate cancer: the PART feasibility RCT. Health Technol Assess. 2018 Sep;22(52):1-96. doi: 10.3310/hta22520.

  PMID: 30264692 BACKGROUND

• Chin JL, Al-Zahrani AA, Autran-Gomez AM, Williams AK, Bauman G. Extended followup oncologic outcome of randomized trial between cryoablation and external beam therapy for locally advanced prostate cancer (T2c-T3b). J Urol. 2012 Oct;188(4):1170-5. doi: 10.1016/j.juro.2012.06.014. Epub 2012 Aug 15.

  PMID: 22901586 BACKGROUND

• Donnelly BJ, Saliken JC, Brasher PM, Ernst SD, Rewcastle JC, Lau H, Robinson J, Trpkov K. A randomized trial of external beam radiotherapy versus cryoablation in patients with localized prostate cancer. Cancer. 2010 Jan 15;116(2):323-30. doi: 10.1002/cncr.24779.

  PMID: 19937954 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Model Details: Randomized prospective open-label

Study Record Dates

• First Submitted: November 16, 2022
• First Posted: April 15, 2025
• Study Start: April 1, 2023
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2025
• Last Updated: April 15, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)