Clinical trial · Interventional
Randomized Trial of HIFU vs. Cryo for Prostate Cancer
Randomized Prospective Trial of Focal Therapy (HIFU vs Cryo) for Early Stage Unifocal Prostate Cancer
NCT06929065CI-TRIAL-00088539KPFTcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cryoablation | — | UNRESOLVED | — |
| HIFU | — | UNRESOLVED | — |
| High Intensity Focused Ultrasound | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Prostate Cancer Stage I | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Prostate Cancer Stage II | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HIFU vs Cryoablation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- HIFU
- description
- HIFU
- interventionNames
- Procedure: HIFU vs Cryoablation
- type
- ACTIVE_COMPARATOR
- label
- Cryoablation
- description
- Cryo
- interventionNames
- Procedure: HIFU vs Cryoablation
Primary outcomes (1)
- measure
- In-field cancer persistence
- timeFrame
- 3 months
- description
- MRI and biopsy results
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. All men age 40 or older with Gleason group 1 or 2 prostate cancer involving a single or adjacent sextants 2. PSA \< 10 3. mpMRI without extracapsular extension or seminal vesicle invasion (non-focal MRI or organ confined) 4. mpMRI which is either nonfocal or concordant with biopsy. Exclusion Criteria: 1. Gleason group 3 or higher 2. Multifocal disease 3. mpMRI with ECE or SVI 4. PSA \> 10 5. Active anorectal disease 6. Age \> 80
References
Publications (11)
- RESULTBakavicius 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
- RESULTGuillaumier 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
- RESULTvon 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
- RESULTWesthoff 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
- RESULTLovegrove 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.