ClinicalTrials.gg
CompletedNCT03503643Updated May 22, 2026

Hemi-Gland Cryoablation for Prostate Cancer at UCLA

An observational study in Prostate Cancer, Prostate Adenocarcinoma and Prostate Disease, sponsored by Jonsson Comprehensive Cancer Center. Completed at 1 site in United States. Open to male participants. Per ClinicalTrials.gov, last updated 2026-05-22.

Sponsored by Jonsson Comprehensive Cancer Center · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
354
Sex
Male
01

Study 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.

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.

02

Conditions studied

  • Prostate Cancer
  • Prostate Adenocarcinoma
  • Prostate Disease

Keywords

  • prostate cancer
  • cryoablation
03

In context

Prostatic Neoplasms

7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.

This study's enrollment of 354 is above the median of 200 across 1,310 observational studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

Jonsson Comprehensive Cancer Center is the lead sponsor of 398 studies on the registry; 66 are open to participants now.

Of its 38 completed or terminated interventional studies of FDA-regulated products, 2 (5%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Male
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 form

Exclusion criteria

Exclusion criteria:

  • Medical to follow-up multi-parametric magnetic resonance imaging (mpMRI) or prostate
  • Patients unable to tolerate general or regional anesthesia.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
354 participants (actual)
Patient registry
No

Interventions

  • DeviceHemigland Cryoablation

    Hemigland cryoablation for the treatment of prostate cancer

    Also known as: cryotherapy

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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.

    Time frame: 6 months

Other outcomes

  1. Quality of Life Assessment - Erectile Function

    Comparison of erectile function pre- and post-treatment will be obtained using the 5-Item International Index of Erectile Function (IIEF-5) Sexual Health Inventory for Men and the Expanded Prostate Cancer Index Composite (EPIC-26) questionnaires to report combined overall erectile function assessments.

    Time frame: 6 months

07

Study locations

1 site
  • University of California, Los Angeles
    Los Angeles, California 90095, United States
08

References and documents

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 ↗
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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2017 to primary completion in Aug 2025, 95 months.

Of 541 non-industry observational studies under Prostatic Neoplasms, half reached primary completion within 67 months of starting (the median), counting those still running; a quarter within 29 and three quarters within 162. This study's 95 months is above that.

Counting every sponsor, half of 650 studies reached it within 60 months; a quarter within 29 and three quarters within 141.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 29, 2018
First posted
Apr 20, 2018
StartActual
Sep 14, 2017
Primary completionActual
Aug 30, 2025
CompletionActual
Aug 30, 2025
Last update
May 22, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03503643
Responsible party
Sponsor
First posted
Apr 20, 2018
Start date
Sep 14, 2017
Primary completion
Aug 30, 2025
Completion
Aug 30, 2025
Last update
May 22, 2026

Study contacts

Leonard S Marks, MD
principal investigator · University of California, Los Angeles

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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