Localized Prostate CarcinomaNCT06178354
Focal Ablation With Focal Cryotherapy or HIFU for the Treatment of Men With Localized Prostate Cancer
A study testing Cryosurgery, High-Intensity Focused Ultrasound Ablation and Survey Administration in people with Localized Prostate Carcinoma and Stage I Prostate Cancer AJCC v8, run by University of California, Davis at 1 site in United States.
Trial summary
This clinical trial evaluates the effectiveness of focal ablation with either focal cryotherapy or high intensity frequency ultrasound for the treatment of men with localized prostate cancer. Focal cryotherapy kills tumor cells by freezing them. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Localized Prostate Carcinoma, Stage I Prostate Cancer AJCC v8, Stage II Prostate Cancer AJCC v8
- What is being tested?
- Cryosurgery, High-Intensity Focused Ultrasound Ablation and Survey Administration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Nov 2023to Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to understand and willingness to sign an informed consent form
- Clinically localized grade group 1, 2, or 3 prostate cancer and unilateral magnetic resonance imaging (MRI) visible lesion(s). Up to 3 lesions will be allowed for focal treatment
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 (Karnofsky ≥ 70%)
- Patients ≥ 18 years of age at time of consent
- Life expectancy ≥ 5 years
- Ability and stated willingness to adhere to the study visit schedule and other protocol procedures/requirements for the duration of the study
Who cannot join
- Nodal or distant metastases
- Prior treatment for prostate cancer
- Anticipated treatment with any cancer intervention, including radiation, hormonal therapy or surgery ≤ 6 months prior to focal therapy in this study
- Known contraindications to general anesthesia
- Uncorrectable coagulopathy
- Significant active cardiac disease within the previous 6 months including: New York Heart Association (NYHA) class 4 congestive heart failure (CHF), unstable angina, or myocardial infarction
- Any condition that would prohibit the understanding or rendering of informed consent
- Any condition that in the opinion of the investigator would interfere with the participant's safety or compliance while on trial
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California Davis Comprehensive Cancer Center
Sacramento, California, 95817
Office of Clinical Research, 916-382-6970, OCRReferral@health.ucdavis.edu
Marc Dall'Era
About this study
Official title: A Pragmatic Phase 2 Study of Focal Ablation (Focal Cryotherapy or High Intensity Frequency Ultrasound) in Men With Clinically Localized Prostate Cancer
This clinical trial evaluates the effectiveness of focal ablation with either focal cryotherapy or high intensity frequency ultrasound for the treatment of men with localized prostate cancer. Focal cryotherapy kills tumor cells by freezing them. High intensity frequency ultrasound uses highly focused ultrasound waves to produce heat and destroy tumor cells.
Read the detailed description
PRIMARY OBJECTIVE:
- To determine the efficacy of focal therapy for treatment of prostate cancer.
SECONDARY OBJECTIVES:
- Patient reported urinary, sexual function and quality of life (QOL) at 1 year.
II. To assess safety.
OUTLINE:
Patients undergo focal cryotherapy or high intensity focused ultrasound on study.
After completion of study treatment, patients are followed up at 7-14 days and periodically for up to 3 years.
- Conditions
- Localized Prostate Carcinoma, Stage I Prostate Cancer AJCC v8, Stage II Prostate Cancer AJCC v8, Stage IIIA Prostate Cancer AJCC v8, Stage IIIB Prostate Cancer AJCC v8
- Being tested
- Cryosurgery, High-Intensity Focused Ultrasound Ablation, Survey Administration
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CryosurgeryProcedure or surgery
Also called Ablation, Cryo, Cryoablation, cryosurgical ablation
Undergo focal cryotherapy ablation
High-Intensity Focused Ultrasound AblationProcedure or surgery
Also called Echopulse, Echotherapy, HIFU, High Intensity Focused Ultrasound
Undergo high intensity frequency ultrasound ablation
Survey AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Treatment (cryosurgery, high intensity focused ultrasound) | Experimental | Patients undergo focal cryotherapy or high intensity focused ultrasound on study. Receives: Procedure: Cryosurgery; Procedure: High-Intensity Focused Ultrasound Ablation; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologic outcome on surveillance prostate biopsy
Confidence intervals for the pathologic response rate will be calculated using the Wilson score method. Pathologic response rate will be analyzed by baseline clinical and molecular characteristics using univariable and multivariable logistic regression.
Measured: At year 1 and 3
Proportion of participants who go onto whole gland salvage treatment
Will be estimated using the Kaplan-Meier method.
Measured: At 3 years
Salvage whole gland treatment free survival
Will be analyzed by baseline clinical and molecular characteristics using univariable and multivariable Cox proportional hazards models.
Measured: At 3 years
Secondary outcomes (4)
Urinary function
Scores from Expanded Prostate Cancer Index Composite (EPIC-26) prostate cancer questionnaire will be used to assess urinary function.
Measured: At 1 year
Sexual function
Scores from EPIC-26 prostate cancer questionnaire will be used to assess sexual function.
Measured: At 1 year
Quality of life
Scores from EPIC-26 prostate cancer questionnaire will be used to assess quality of life.
Measured: At 1 year
Adverse events
Number of participants experiencing treatment-related AEs, classified by severity and grade.
Measured: Up to end of treatment visit, approximately 7-14 days after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2023
- Study start9 Nov 2023
- Primary completionNov 2028 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Localized Prostate CarcinomaStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Marc Dall'Era, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06178354
- Sponsor's protocol ID
- UCDCC306
- Other IDs
- NCI-2023-09811, UCDCC306, P30CA093373
- Status last verified
- Jun 2026
- First submitted
- 9 Dec 2023
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pragmatic Phase 2 Study of Focal Ablation (Focal Cryotherapy or High Intensity Frequency Ultrasound) in Men With Clinically Localized Prostate Cancer
- ClinicalTrials.gov ID
- NCT06178354
- Acronym / sponsor ID
- UCDCC306
- Conditions
- Localized Prostate Carcinoma, Stage I Prostate Cancer AJCC v8, Stage II Prostate Cancer AJCC v8, Stage IIIA Prostate Cancer AJCC v8, Stage IIIB Prostate Cancer AJCC v8
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 9 Nov 2023 (actual)
- Primary completion
- Nov 2028 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 21 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial evaluates the effectiveness of focal ablation with either focal cryotherapy or high intensity frequency ultrasound for the treatment of men with localized prostate cancer. Focal cryotherapy kills tumor cells by freezing them. High intensity frequency ultrasound uses highly focused ultrasound waves to produce heat and destroy tumor cells.
Detailed description
PRIMARY OBJECTIVE:
- To determine the efficacy of focal therapy for treatment of prostate cancer.
SECONDARY OBJECTIVES:
- Patient reported urinary, sexual function and quality of life (QOL) at 1 year.
II. To assess safety.
OUTLINE:
Patients undergo focal cryotherapy or high intensity focused ultrasound on study.
After completion of study treatment, patients are followed up at 7-14 days and periodically for up to 3 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (cryosurgery, high intensity focused ultrasound) | Experimental | Procedure: Cryosurgery, Procedure: High-Intensity Focused Ultrasound Ablation, Other: Survey AdministrationPatients undergo focal cryotherapy or high intensity focused ultrasound on study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Ability to understand and willingness to sign an informed consent form
- Clinically localized grade group 1, 2, or 3 prostate cancer and unilateral magnetic resonance imaging (MRI) visible lesion(s). Up to 3 lesions will be allowed for focal treatment
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 (Karnofsky ≥ 70%)
- Patients ≥ 18 years of age at time of consent
- Life expectancy ≥ 5 years
Key exclusion criteria (8 listed)
- Nodal or distant metastases
- Prior treatment for prostate cancer
- Anticipated treatment with any cancer intervention, including radiation, hormonal therapy or surgery ≤ 6 months prior to focal therapy in this study
- Known contraindications to general anesthesia
- Uncorrectable coagulopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CryosurgeryAlso: Ablation, Cryo, Cryoablation, cryosurgical ablationUndergo focal cryotherapy ablation | Procedure or surgery | Treatment (cryosurgery, high intensity focused ultrasound) |
| High-Intensity Focused Ultrasound AblationAlso: Echopulse, Echotherapy, HIFU, High Intensity Focused UltrasoundUndergo high intensity frequency ultrasound ablation | Procedure or surgery | Treatment (cryosurgery, high intensity focused ultrasound) |
| Survey AdministrationAncillary studies | Other | Treatment (cryosurgery, high intensity focused ultrasound) |
Primary outcome
Pathologic outcome on surveillance prostate biopsy
Time frame: At year 1 and 3
Confidence intervals for the pathologic response rate will be calculated using the Wilson score method. Pathologic response rate will be analyzed by baseline clinical and molecular characteristics using univariable and multivariable logistic regression.
Proportion of participants who go onto whole gland salvage treatment
Time frame: At 3 years
Will be estimated using the Kaplan-Meier method.
Salvage whole gland treatment free survival
Time frame: At 3 years
Will be analyzed by baseline clinical and molecular characteristics using univariable and multivariable Cox proportional hazards models.
4 secondary outcomes
Urinary function
Time frame: At 1 year
Sexual function
Time frame: At 1 year
Quality of life
Time frame: At 1 year
Adverse events
Time frame: Up to end of treatment visit, approximately 7-14 days after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marc Dall'Era principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryosurgery, High-Intensity Focused Ultrasound Ablation and Survey Administration in people with Localized Prostate Carcinoma and Stage I Prostate Cancer AJCC v8, run by University of California, Davis 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 6 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 30 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Office of Clinical Research (916-382-6970, OCRReferral@health.ucdavis.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathologic outcome on surveillance prostate biopsy (time frame: At year 1 and 3). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jun 2026; AzTrials last refreshed its copy on 8 Nov 2026.