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Prostate CancerKPFTNCT06929065

Randomized Trial of HIFU vs. Cryo for Prostate Cancer

A study testing HIFU vs Cryoablation in people with Prostate Cancer and Prostate Cancer Stage I, run by Kaiser Permanente at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 to 80 years, men onlyHealthy volunteers can take part
What is being tested?
HIFU vs Cryoablation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteUnited States
Study dates
1 Apr 2023to 1 Feb 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 80 years
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Kaiser Permanente

    Los Angeles, California, 90077

Other trials in United States

About this study

Official title: Randomized Prospective Trial of Focal Therapy (HIFU vs Cryo) for Early Stage Unifocal Prostate Cancer

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.

Read the detailed description

All men presenting with elevated prostate specific antigen (PSA) will be required to undergo an initial multiparametric MRI (MRI) and 14 core systematic biopsy. Decipher genomic testing will be run on all prostate cancer specimens. 48 men with with unifocal low-intermediate risk prostate cancer (clinical stage T1-T2, Gleason group 1-2) prostate cancer will be offered focal therapy vs. conventional therapy (surgery or radiation) via shared decision making. Those who elect focal therapy (FT) will be enrolled and randomized 1:1 to HIFU or cryoablation. Men with negative biopsy, multifocal disease, or unfavorable intermediate risk or higher disease will be excluded and offered standard therapy (surgery or radiation).

Following treatment, mpMRI and biopsy will be performed at 3mo. Baseline, 3mo, 6mo and 12mo post-treatment PSA will be obtained. In field and out of field cancer recurrence will be determined. Baseline and 3mo American Urologic Association Symptom Score (AUAss) and International Index of Erectile Function (IIEF) will be recorded as well as any treatment related side-effects or complications. SpaceOAR hydrogel will be utilized for all posterior lesions.

Being tested
HIFU vs Cryoablation
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HIFU vs CryoablationProcedure or surgery

    HIFU vs cryoablation

Study groups in NCT06929065
Study groupRoleWhat they receive
HIFUExperimentalHIFU
Receives: Procedure: HIFU vs Cryoablation
CryoablationActive comparatorCryo
Receives: Procedure: HIFU vs Cryoablation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. In-field cancer persistence

    MRI and biopsy results

    Measured: 3 months

Secondary outcomes (4)

  1. AUAss change from baseline

    Change in urination over

    Measured: month 3, month 6, month 12, month 24

  2. IIEF change from baseline

    Change in sexual function over time

    Measured: month 3, month 6, month 12, month 24

  3. Complications and satisfaction

    Measured: month 3, month 6, month 12, month 24

  4. PSA

    PSA change over time

    Measured: month 3, month 6, month 12, month 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Apr 2025
  2. Study start1 Apr 2023
  3. Primary completion1 Feb 2025
  4. Study completion1 Feb 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized prospective open-label
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06929065
Sponsor's protocol ID
KPFT
Acronym
KPFT
Status last verified
Apr 2025
First submitted
16 Nov 2022
Last updated
15 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 34003610

  • 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.

    PubMed 29960750

  • 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.

    PubMed 30093211

  • 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.

    PubMed 32533247

  • 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.

    PubMed 31971335

  • 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.

    PubMed 32051551

  • 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.

    PubMed 20564422

  • 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.

    PubMed 26597660

  • 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.

    PubMed 30264692

  • 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.

    PubMed 22901586

  • 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.

    PubMed 19937954

Questions about this trial

What is this clinical trial studying?

A study testing HIFU vs Cryoablation in people with Prostate Cancer and Prostate Cancer Stage I, run by Kaiser Permanente at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

In-field cancer persistence (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06929065, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2025.

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