Prostate CancerNCT03503643
Hemi-Gland Cryoablation for Prostate Cancer at UCLA
An observational study of Prostate Cancer and Prostate Adenocarcinoma, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
Trial summary
This is a prospective data collection of men who are electing to undergo prostate hemi-gland cryoablation. The purpose of this observational research study is to investigate the localized treatment of prostate cancer using hemi-gland cryoablation. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer, Prostate Adenocarcinoma, Prostate Disease
- What is being tested?
- Hemigland Cryoablation
- Type of treatment
- Medical device
- How many people
- 354 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Sep 2017to 30 Aug 2025
- Phase
- Observational
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who are candidates for hemi-gland cryoablation, and elect this treatment option as a standard of care procedure, will be considered for our clinical study and analysis of their outcomes. Subjects will provide informed consent to participate in this study during standard of care clinical visits at the Clark Urology Center at UCLA. Subjects will provide informed consent to allow study staff to abstract data from their medical records.
Who may be able to join
- Patient has undergone or has elected to undergo hemi-gland cryoablation at UCLA
- Low or intermediate risk prostate cancer (Gleason ≤ 7) or select high-risk patients (Gleason 8 prostate cancer).
- Prostate volume of ≤ 70 cc
- Ability to complete informed consent form
Who cannot join
- Medical contraindication to follow-up multi-parametric magnetic resonance imaging (mpMRI) or prostate biopsy
- Patients unable to tolerate general or regional anesthesia.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Los Angeles
Los Angeles, California, 90095
About this study
Official title: Cryoablation: An Observational Study of Hemi-Gland Cryoablation Outcomes for Prostate Cancer at University of California at Los Angeles (UCLA)
This is a prospective data collection of men who are electing to undergo prostate hemi-gland cryoablation.
The purpose of this observational research study is to investigate the localized treatment of prostate cancer using hemi-gland cryoablation.
UCLA patients undergoing hemi-gland cryoablation are a unique cohort compared to prior research because all patients at UCLA have had a pre-treatment multi-parametric MRI and Ultrasound fusion targeted biopsy; they will be followed in a similar fashion. This results in more precise assessment of a target region of cancer for ablation which may, in turn, result in improved clinical outcomes.
- Conditions
- Prostate Cancer, Prostate Adenocarcinoma, Prostate Disease
- Being tested
- Hemigland Cryoablation
- Keywords
- prostate cancer, cryoablation
- Medical subject headings
- Prostatic Neoplasms, Prostatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemigland CryoablationDevice
Also called cryotherapy
Hemigland cryoablation for the treatment of prostate cancer
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Response to Cancer Treatment
Our primary endpoint will be a patient's clinical response to cancer treatment, specifically, the degree of prostate cancer on a post-treatment fusion biopsy compared to pre-treatment.
Measured: 6 months
Secondary outcomes (1)
Quality of Life Assessment - Urinary Function
Comparison of urinary function pre- and post-treatment will be obtained using the International Prostate Symptom Score (IPSS) and the Expanded Prostate Cancer Index Composite (EPIC-26) questionnaires to report combined overall urinary function assessments.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2018
- Study start14 Sep 2017
- Primary completion30 Aug 2025
- Study completion30 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Jonsson Comprehensive Cancer CenterThe 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
- 354 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Leonard S Marks, MD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03503643
- Sponsor's protocol ID
- 17-001084
- Status last verified
- May 2026
- First submitted
- 29 Mar 2018
- Last updated
- 22 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Weiner AB, Proudfoot JA, Aker M, Cardenas M, Gonzalez S, Kelly E, Davicioni E, Sisk AE Jr, Brisbane WG, Marks LS. Genomic Biomarker for Prostate Cancer Focal Therapy: Post Hoc Assessment of a Phase II Clinical Trial. JCO Precis Oncol. 2025 Sep;9:e2500535. doi: 10.1200/PO-25-00535. Epub 2025 Sep 17.
PubMed 40961406
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cryoablation: An Observational Study of Hemi-Gland Cryoablation Outcomes for Prostate Cancer at University of California at Los Angeles (UCLA)
- ClinicalTrials.gov ID
- NCT03503643
- Acronym / sponsor ID
- 17-001084
- Conditions
- Prostate Cancer, Prostate Adenocarcinoma, Prostate Disease
- Keywords
- prostate cancer, cryoablation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 354 participants (actual)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 14 Sep 2017 (actual)
- Primary completion
- 30 Aug 2025 (actual)
- Study completion
- 30 Aug 2025 (actual)
- First posted
- 20 Apr 2018 (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 is a prospective data collection of men who are electing to undergo prostate hemi-gland cryoablation.
The purpose of this observational research study is to investigate the localized treatment of prostate cancer using hemi-gland cryoablation.
UCLA patients undergoing hemi-gland cryoablation are a unique cohort compared to prior research because all patients at UCLA have had a pre-treatment multi-parametric MRI and Ultrasound fusion targeted biopsy; they will be followed in a similar fashion. This results in more precise assessment of a target region of cancer for ablation which may, in turn, result in improved clinical outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who are candidates for hemi-gland cryoablation, and elect this treatment option as a standard of care procedure, will be considered for our clinical study and analysis of their outcomes. Subjects will provide informed consent to participate in this study during standard of care clinical visits at the Clark Urology Center at UCLA. Subjects will provide informed consent to allow study staff to abstract data from their medical records.
Key inclusion criteria (4 listed)
- Patient has undergone or has elected to undergo hemi-gland cryoablation at UCLA
- Low or intermediate risk prostate cancer (Gleason ≤ 7) or select high-risk patients (Gleason 8 prostate cancer).
- Prostate volume of ≤ 70 cc
- Ability to complete informed consent form
Key exclusion criteria (2 listed)
- Medical contraindication to follow-up multi-parametric magnetic resonance imaging (mpMRI) or prostate biopsy
- Patients unable to tolerate general or regional anesthesia.
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 |
|---|---|---|
| Hemigland CryoablationAlso: cryotherapyHemigland cryoablation for the treatment of prostate cancer | Device | – |
Primary outcome
Clinical Response to Cancer Treatment
Time frame: 6 months
Our primary endpoint will be a patient's clinical response to cancer treatment, specifically, the degree of prostate cancer on a post-treatment fusion biopsy compared to pre-treatment.
1 secondary outcome
Quality of Life Assessment - Urinary Function
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Derived from this study: PubMed 40961406Weiner AB, Proudfoot JA, Aker M, Cardenas M, Gonzalez S, Kelly E, Davicioni E, Sisk AE Jr, Brisbane WG, Marks LS. Genomic Biomarker for Prostate Cancer Focal Therapy: Post Hoc Assessment of a Phase II Clinical Trial. JCO Precis Oncol. 2025 Sep;9:e2500535. doi: 10.1200/PO-25-00535. Epub 2025 Sep 17.
Related trials for Prostate Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
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. This study is not recruiting at the moment.
Leonard S Marks, MD principal investigator
University of California, Los Angeles
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 and Prostate Adenocarcinoma, run by Jonsson Comprehensive Cancer Center 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 2 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 22 May 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?
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?
Clinical Response to Cancer Treatment (time frame: 6 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 NCT03503643, which also lists 1 linked publication.
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 22 May 2026.