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Procedure

Treatment (cryosurgery, high intensity focused ultrasound) for Prostate Cancer

N/A

Recruiting

Led By Marc Dall'Era

Research Sponsored by Marc Dall'Era, MD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 (Karnofsky ≥ 70%)

Patients ≥ 18 years of age at time of consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at year 1 and 3

Awards & highlights

Study Summary

This trial is testing two different methods, focal cryotherapy and high intensity frequency ultrasound, to treat localized prostate cancer in men. Focal cryotherapy freezes the tumor cells to kill them, while high intensity

Who is the study for?

This trial is for men with localized prostate cancer. Specific eligibility criteria are not provided, but typically participants would need to meet certain health standards and have a diagnosis that fits the study's requirements.Check my eligibility

What is being tested?

The effectiveness of two treatments for localized prostate cancer is being tested: focal cryotherapy, which freezes tumor cells, and high-intensity focused ultrasound (HIFU), which uses heat to destroy them.See study design

What are the potential side effects?

Potential side effects may include discomfort or pain at the treatment site, urinary issues due to prostate irritation, and risks associated with anesthesia used during procedures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am mostly active and can care for myself.

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I am 18 years old or older.

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I can and will follow the study's schedule and rules.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at year 1 and 3

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at year 1 and 3

This trial's timeline: 3 weeks for screening, Varies for treatment, and at year 1 and 3 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Pathologic outcome on surveillance prostate biopsy

Proportion of participants who go onto whole gland salvage treatment

Salvage whole gland treatment free survival

Secondary outcome measures

Adverse events

Quality of life

Sexual function

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (cryosurgery, high intensity focused ultrasound)Experimental Treatment3 Interventions

Patients undergo focal cryotherapy or high intensity focused ultrasound on study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cryosurgery

2015

Completed Phase 4

~540

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,667 Previous Clinical Trials

40,926,066 Total Patients Enrolled

561 Trials studying Prostate Cancer

507,095 Patients Enrolled for Prostate Cancer

Marc Dall'Era, MDLead Sponsor

1 Previous Clinical Trials

30 Total Patients Enrolled

1 Trials studying Prostate Cancer

30 Patients Enrolled for Prostate Cancer

Marc Dall'EraPrincipal InvestigatorUniversity of California, Davis

1 Previous Clinical Trials

30 Total Patients Enrolled

1 Trials studying Prostate Cancer

30 Patients Enrolled for Prostate Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the anticipated results that researchers hope to achieve through this experimental investigation?

"The primary objective of this clinical trial is to evaluate the proportion of participants who require whole gland salvage treatment. Secondary objectives include assessing urinary function, sexual function, and quality of life using scores from the EPIC-26 prostate cancer questionnaire. These assessments will take place at approximately year 1 and year 3."

Answered by AI

Are there any available positions for participants in this research study?

"Indeed, the details provided on clinicaltrials.gov confirm that this research study is actively seeking eligible participants. The initial posting of this trial occurred on November 9th, 2023 and it was last updated on December 9th, 2023. The study aims to enroll a total of 100 individuals at one designated site."

Answered by AI

What is the upper limit on the number of participants involved in this clinical investigation?

"Indeed, the information found on clinicaltrials.gov indicates that this particular clinical trial is actively seeking participants. The initial posting of the study was on November 9th, 2023, and it underwent its most recent update on December 9th, 2023. The goal is to recruit a total of 100 patients from a single designated location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Focal Ablation With Focal Cryotherapy or HIFU for the Treatment of Men With Localized Prostate Cancer

Marc Dall'Era, MD 2023. "Focal Ablation With Focal Cryotherapy or HIFU for the Treatment of Men With Localized Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06178354.

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