Prostate CancerNCT07623941
CUIMC Focal Therapy Registry
An observational study of Prostate Cancer, run by Columbia University at 1 site in United States.
Trial summary
Patients undergoing high intensity focused ultrasound (HIFU) or irreversible electroporation (IRE) for prostate cancer will be invited to consent to have their data collected in a detailed comprehensive system to record and store patient, disease, and treatment-related characteristics. Read more about this study
- Who is it for?
- Ages 40 to 85 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Focal therapy
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2026to 31 Dec 2040
- How long will I take part?
- 10 Years
- Phase
- Observational
- 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 40 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with localized prostate cancer
Who may be able to join
- Organ-confined prostate adenocarcinoma diagnosed by MRI/ultrasound fusion biopsy within a multiparametric MRI derived region of interest
- Clinical stage T2cN0M0 (radiological T3a is permitted)
- Multi-parametric MRI at New York-Presbyterian hospital (NYPH) within the past 6 months demonstrating region of interest suspicion level 2 by the Prostate Imaging Reporting and Data System version 2.0 scoring criteria
- Transrectal or transperineal ultrasound-guided biopsy with 10 template biopsy cores and 2 MRI-ultrasound fusion targeted biopsy cores from the above MRI-derived region of interest demonstrating:
- histologically confirmed prostate adenocarcinoma from targeted biopsy cores
- unilateral Gleason score 4+3 prostate adenocarcinoma
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- Age 40 to 85 years of age
- Subjects choose to undergo focal therapy and decline alternative treatment (such as active surveillance, radical prostatectomy, radiation therapy, cryosurgery or hormone therapy)
- Signed informed consent
Who cannot join
- Any Gleason score 4+4 outside an MRI-identified region of interest
- Prostatic calcifications which in the opinion of the investigator would impede delivery of the energy to tumor in patients choosing HIFU
- Any medical condition that would compromise the subject's ability to safely participate in the study
- American Society of Anesthesiologists (ASA) criteria of IV or higher
- Active urinary tract infection
- Rectal fissure, fibrosis, stenosis, or other anatomic abnormality precluding insertion of transrectal device
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- Active, uncontrolled inflammatory bowel disease
- Urinary tract or rectal fistula
- Previous urethral sling, artificial urinary sphincter, or penile prosthesis surgery
- Any contraindication to MRI (such as contrast allergy, sever claustrophobia, MRI-incompatible prosthesis)
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
Columbia University Irving Medical Center
New York, New York, 10032
Izak Faiena, 212-305-0114, if2274@cumc.columbia.edu
Izak Faiena, MD, MSCR
About this study
Official title: Columbia University Prostate Cancer Focal Therapy Registry
Patients undergoing high intensity focused ultrasound (HIFU) or irreversible electroporation (IRE) for prostate cancer will be invited to consent to have their data collected in a detailed comprehensive system to record and store patient, disease, and treatment-related characteristics. No treatment will be given, no randomization will occur, and each patient seen and treated for prostate cancer specifically with HIFU and IRE method in the Department of Urology division of Urologic Oncology within Columbia University Irving Medical Center will be eligible to be enrolled in the database.
Read the detailed description
The primary objective of this study is to evaluate surgical, oncologic, functional, and quality-of-life outcomes following focal treatment with high-intensity focused ultrasound (HIFU) or irreversible electroporation (IRE) in patients with localized prostate cancer. The study will assess the feasibility and efficacy of focal prostate tissue ablation using these treatment approaches.
Multiparametric MRI will be used to identify regions of interest within the prostate and to support treatment planning and targeting. The investigators aim to further characterize outcomes after focal ablation with HIFU and IRE, including treatment-related effects, cancer control, and patient-reported quality-of-life measures.
In addition, the study will examine factors associated with ablation success, including targeting strategy and post-treatment assessment methods. Follow-up biopsy protocols will also be evaluated to determine their role in assessing treatment efficacy and confirming lesion ablation after focal therapy.
- Conditions
- Prostate Cancer
- Being tested
- Focal therapy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focal therapyProcedure or surgery
Also called High Intensity Focused Ultrasound, Irreversible Electroporation
Focal ablation of prostate cancer using IRE or HIFU
What is being measured
The primary outcome is the main question the study is designed to answer.
Failure free survival
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2026
- Study start1 Jan 2026
- Primary completion31 Dec 2035 (estimated)
- Study completion31 Dec 2040 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Izak Faiena, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07623941
- Sponsor's protocol ID
- AAAU8649
- Status last verified
- May 2026
- First submitted
- 29 May 2026
- Last updated
- 3 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Columbia University Prostate Cancer Focal Therapy Registry
- ClinicalTrials.gov ID
- NCT07623941
- Acronym / sponsor ID
- AAAU8649
- Conditions
- Prostate Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 31 Dec 2035 (estimated)
- Study completion
- 31 Dec 2040 (estimated)
- First posted
- 3 Jun 2026 (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.
Patients undergoing high intensity focused ultrasound (HIFU) or irreversible electroporation (IRE) for prostate cancer will be invited to consent to have their data collected in a detailed comprehensive system to record and store patient, disease, and treatment-related characteristics. No treatment will be given, no randomization will occur, and each patient seen and treated for prostate cancer specifically with HIFU and IRE method in the Department of Urology division of Urologic Oncology within Columbia University Irving Medical Center will be eligible to be enrolled in the database.
Detailed description
The primary objective of this study is to evaluate surgical, oncologic, functional, and quality-of-life outcomes following focal treatment with high-intensity focused ultrasound (HIFU) or irreversible electroporation (IRE) in patients with localized prostate cancer. The study will assess the feasibility and efficacy of focal prostate tissue ablation using these treatment approaches.
Multiparametric MRI will be used to identify regions of interest within the prostate and to support treatment planning and targeting. The investigators aim to further characterize outcomes after focal ablation with HIFU and IRE, including treatment-related effects, cancer control, and patient-reported quality-of-life measures.
In addition, the study will examine factors associated with ablation success, including targeting strategy and post-treatment assessment methods. Follow-up biopsy protocols will also be evaluated to determine their role in assessing treatment efficacy and confirming lesion ablation after focal therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 40 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with localized prostate cancer
Key inclusion criteria (9 listed)
- Organ-confined prostate adenocarcinoma diagnosed by MRI/ultrasound fusion biopsy within a multiparametric MRI derived region of interest
- Clinical stage T2cN0M0 (radiological T3a is permitted)
- Multi-parametric MRI at New York-Presbyterian hospital (NYPH) within the past 6 months demonstrating region of interest suspicion level 2 by the Prostate Imaging Reporting and Data System version 2.0 scoring criteria
- Transrectal or transperineal ultrasound-guided biopsy with 10 template biopsy cores and 2 MRI-ultrasound fusion targeted biopsy cores from the above MRI-derived region of interest demonstrating:
- Age 40 to 85 years of age
Key exclusion criteria (10 listed)
- Any Gleason score 4+4 outside an MRI-identified region of interest
- Prostatic calcifications which in the opinion of the investigator would impede delivery of the energy to tumor in patients choosing HIFU
- Any medical condition that would compromise the subject's ability to safely participate in the study
- American Society of Anesthesiologists (ASA) criteria of IV or higher
- Active urinary tract infection
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 |
|---|---|---|
| Focal therapyAlso: High Intensity Focused Ultrasound, Irreversible ElectroporationFocal ablation of prostate cancer using IRE or HIFU | Procedure or surgery | – |
Primary outcome
Failure free survival
Time frame: 10 years
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 3 Jun 2026.
- Individual participant dataSharing planned: No
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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.
Columbia University Irving Medical Center
New York, United States
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Columbia University 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 9 inclusion and 10 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 3 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Failure free survival (time frame: 10 years). 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 3 Jun 2026.