Prostate CancerNCT06270043
Focal Therapy for Localized Prostate Cancer
An observational study of Prostate Cancer, run by University of California, San Diego at 1 site in United States.
Trial summary
This prospective registry and longitudinal study that is designed to carefully measure details of prostate cancer patients' outcomes with focal therapy. The goal of which is to improve patient care. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Focal Therapy
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2024to 1 Feb 2034
- 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 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects who have biopsy-proven adenocarcinoma of the prostate, who have met all study inclusion and exclusion criteria, and have elected to receive or have already received the focal therapy as part of their routine prostate cancer treatment, will be invited to participate in this observational registry study.
Who may be able to join
- Subject has elected or already undergone focal therapy as their standard of care treatment method and declined alternative treatment (active surveillance, radical prostatectomy, and radiation therapy)
- PSA ≤ 20
- Ability to complete informed consent form
Who cannot join
- Contraindication to follow-up multi parametric MRI or prostate biopsy
- Unable to tolerate general or regional anesthesia
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, San Diego
La Jolla, California, 92121
Juan Javier-DesLoges, MD, 858-657-8786, jjavierdesloges@health.ucsd.edu
About this study
Official title: A Prospective Registry and Longitudinal Study of Patients Undergoing Focal Therapy for Localized Prostate Cancer
This prospective registry and longitudinal study that is designed to carefully measure details of prostate cancer patients' outcomes with focal therapy. The goal of which is to improve patient care.
Read the detailed description
This observational study will serve to collect data from medical record and review questionnaires before and after focal ablation of prostate tissue. All enrolled subjects will have already undergone or scheduled to receive the focal therapy as part of their prostate cancer treatment.
- Conditions
- Prostate Cancer
- Being tested
- Focal Therapy
- Keywords
- Focal Therapy, High Intensity Frequency Ultrasound, Transurethral Ultrasound Ablation, Cryoablation, Irreversible Electroporation
- 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
Focal ablation of prostate cancer using different modalities. These modalities include:
- Cryoablation or Cryotherapy
- Irreversible Electroporation - Nanoknife
- High Intensity Frequency Ultrasound - FocalOne
- Transurethral Ultrasound Ablation - TULSA - PRO
| Study group | Role | What they receive |
|---|---|---|
| Focal Therapy | Subjects who have biopsy-proven adenocarcinoma of the prostate, who have met all study inclusion and exclusion criteria, and have elected to receive or have already received focal therapy as part of their routine prostate cancer treatment, will be invited to participate in this observational registry study. Receives: Procedure: Focal Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oncological Response
The following definitions will be used for evaluation of oncological response:
Complete response: Ablation of prostate tissue in targeted biopsy cores at 12 months.
Incomplete response: Residual disease at 12 months compared to baseline in target biopsy cores or systematic biopsy cores.
Measured: 1 year
Secondary outcomes (3)
Erectile Dysfunction
Assess impact on erections after ablation. The Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP) questionnaire will be used to evaluate sexual health quality-of-life symptoms for participants pre- and post-ablation.
Patients will receive a score between 0 and 12, 0 being low with a better outcome and 12 being high with a worse outcome.
Measured: 1 year
Incontinence
Assess impact on continence after ablation. The Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP) questionnaire will be used to evaluate urinary health quality-of-life symptoms for participants pre- and post-ablation.
Patients will receive a score between 0 and 12, 0 being low with a better outcome and 12 being high with a worse outcome.
Measured: 1 year
Prostate cancer recurrence. Patients will be monitored with a Prostate Specific Antigen (PSA) every 6 months until 10 years from the intervention. Patients with a rising PSA will receive a prostate biopsy to determine if they have a recurrence.
Assess long-term recurrence risk after ablation
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 posted21 Feb 2024
- Study start1 Feb 2024
- Primary completion1 Feb 2034 (estimated)
- Study completion1 Feb 2034 (estimated)
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 University of California, San DiegoThe 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
- 500 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan Javier-DesLoges, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06270043
- Sponsor's protocol ID
- 809622
- Status last verified
- Feb 2024
- First submitted
- 11 Feb 2024
- Last updated
- 26 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Javier-DesLoges J, Dall'Era MA, Brisbane W, Chamie K, Washington SL 3rd, Chandrasekar T, Marks LS, Nguyen H, Daneshvar M, Gin G, Kane CJ, Bagrodia A, Cooperberg MR. The state of focal therapy in the treatment of prostate cancer: the university of California collaborative (UC-Squared) consensus statement. Prostate Cancer Prostatic Dis. 2024 Dec;27(4):579-581. doi: 10.1038/s41391-023-00702-1. Epub 2023 Aug 8. No abstract available.
PubMed 37553435
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Registry and Longitudinal Study of Patients Undergoing Focal Therapy for Localized Prostate Cancer
- ClinicalTrials.gov ID
- NCT06270043
- Acronym / sponsor ID
- 809622
- Conditions
- Prostate Cancer
- Keywords
- Focal Therapy, High Intensity Frequency Ultrasound, Transurethral Ultrasound Ablation, Cryoablation, Irreversible Electroporation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 Feb 2034 (estimated)
- Study completion
- 1 Feb 2034 (estimated)
- First posted
- 21 Feb 2024 (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 prospective registry and longitudinal study that is designed to carefully measure details of prostate cancer patients' outcomes with focal therapy. The goal of which is to improve patient care.
Detailed description
This observational study will serve to collect data from medical record and review questionnaires before and after focal ablation of prostate tissue. All enrolled subjects will have already undergone or scheduled to receive the focal therapy as part of their prostate cancer treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Focal Therapy | – | Procedure: Focal TherapySubjects who have biopsy-proven adenocarcinoma of the prostate, who have met all study inclusion and exclusion criteria, and have elected to receive or have already received focal therapy as part of their routine prostate cancer treatment, will be invited to participate in this observational registry study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who have biopsy-proven adenocarcinoma of the prostate, who have met all study inclusion and exclusion criteria, and have elected to receive or have already received the focal therapy as part of their routine prostate cancer treatment, will be invited to participate in this observational registry study.
Key inclusion criteria (3 listed)
- Subject has elected or already undergone focal therapy as their standard of care treatment method and declined alternative treatment (active surveillance, radical prostatectomy, and radiation therapy)
- PSA ≤ 20
- Ability to complete informed consent form
Key exclusion criteria (2 listed)
- Contraindication to follow-up multi parametric MRI or prostate biopsy
- 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 |
|---|---|---|
| Focal TherapyFocal ablation of prostate cancer using different modalities. These modalities include: * Cryoablation or Cryotherapy * Irreversible Electroporation - Nanoknife * High Intensity Frequency Ultrasound - FocalOne * Transurethral Ultrasound Ablation - TULSA - PRO | Procedure or surgery | Focal Therapy |
Primary outcome
Oncological Response
Time frame: 1 year
The following definitions will be used for evaluation of oncological response: Complete response: Ablation of prostate tissue in targeted biopsy cores at 12 months. Incomplete response: Residual disease at 12 months compared to baseline in target biopsy cores or systematic biopsy cores.
3 secondary outcomes
Erectile Dysfunction
Time frame: 1 year
Incontinence
Time frame: 1 year
Prostate cancer recurrence. Patients will be monitored with a Prostate Specific Antigen (PSA) every 6 months until 10 years from the intervention. Patients with a rising PSA will receive a prostate biopsy to determine if they have a recurrence.
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 26 Feb 2024.
- Background: PubMed 37553435Javier-DesLoges J, Dall'Era MA, Brisbane W, Chamie K, Washington SL 3rd, Chandrasekar T, Marks LS, Nguyen H, Daneshvar M, Gin G, Kane CJ, Bagrodia A, Cooperberg MR. The state of focal therapy in the treatment of prostate cancer: the university of California collaborative (UC-Squared) consensus statement. Prostate Cancer Prostatic Dis. 2024 Dec;27(4):579-581. doi: 10.1038/s41391-023-00702-1. Epub 2023 Aug 8. No abstract available.
- Individual participant dataSharing planned: Undecided
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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.
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 University of California, San Diego 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 3 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: looking for participants now, as of the sponsor's last update on 26 Feb 2024. 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 Juan Javier-DesLoges, MD (858-657-8786, jjavierdesloges@health.ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oncological Response (time frame: 1 year). 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 NCT06270043, 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 26 Feb 2024.