3000 Participants Needed

Prostate Ablation for Prostate Cancer

Recruiting at 1 trial location
AS
LY
Overseen ByLeila Yazdanbakhsh
Age: 18+
Sex: Male
Trial Phase: Academic
Sponsor: University of Chicago
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial collects information on prostate ablation, a treatment designed to destroy prostate cancer cells with minimal invasion. The goal is to evaluate the long-term effectiveness and potential side effects of this method. Men diagnosed with prostate cancer who are scheduled for or have already undergone prostate ablation (using methods like cryotherapy or laser treatment) can participate. The trial gathers data from medical records, ensuring participants face no physical risks or need for extra procedures. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that prostate ablation is safe for prostate cancer patients?

Research has shown that prostate ablation is generally safe for men with early-stage prostate cancer. Studies have found the procedure to be feasible and well-tolerated, with no serious side effects reported. For instance, one study found that this treatment resulted in good urinary and sexual health.

Another study showed that even six months after treatment, there were no major safety concerns. Only a small number of patients experienced cancer recurrence in or around the treated area. This indicates that while the treatment is mostly safe, regular check-ups are important for long-term success.

Overall, prostate ablation appears to be a promising option with a good safety record, especially for those with early-stage prostate cancer. However, more information is still being collected about its long-term effectiveness.12345

Why are researchers excited about this trial?

Researchers are excited about prostate ablation for prostate cancer because it offers a minimally invasive option compared to traditional treatments like surgery or radiation. Unlike these standard treatments, prostate ablation targets and destroys cancerous tissue using precise energy delivery, which can lead to fewer side effects and a quicker recovery time. This approach holds promise for effectively managing cancer while preserving quality of life, making it a compelling alternative for patients seeking less invasive options.

What evidence suggests that prostate ablation is effective for prostate cancer?

Research has shown that prostate ablation, which participants in this trial will undergo, can effectively treat prostate cancer, especially when the cancer remains localized. One study found that after focal ablation, about 80% of men had no significant cancer detected. Another study demonstrated that targeted microwave ablation lowered prostate-specific antigen (PSA) levels, indicating the treatment's effectiveness. Importantly, prostate ablation can avoid the severe side effects of more aggressive treatments. It has also helped many patients maintain good urinary and sexual function. Therefore, prostate ablation is a promising option for managing prostate cancer, offering lower risks of progression compared to mere monitoring.26789

Who Is on the Research Team?

AS

Abhinav Sidana, MD

Principal Investigator

University of Chicago

Are You a Good Fit for This Trial?

Inclusion Criteria

I am 22 years old or older.
I am male.
I am scheduled for or have had prostate ablation.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo prostate ablation for the management of prostate cancer

1-2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

10 years
Follow up every 6 months for 2 years, and annually through 10 years

What Are the Treatments Tested in This Trial?

Interventions

  • Prostate Ablation

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Prostate Cancer Patients Undergoing Prostate AblationExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials
1,086
Recruited
844,000+

University of Cincinnati

Collaborator

Trials
442
Recruited
639,000+

Citations

A systematic review of outcomes after thermal and ...

VTP is promising and has been shown to be safe and effective in low-risk patients, with lower rates of disease progression than AS. The side effect profile is ...

A multi-center international study to evaluate the safety ...

For men with localized prostate cancer, IRE could achieve good urinary and sexual function outcomes and a reasonable oncological result. The ...

Fifteen-Year Outcomes after Monitoring, Surgery, or ...

After median follow-up of 15 years, 45 patients (2.7%) had died of prostate cancer: 17 (3.1%) in the active-monitoring group, 12 (2.2%) in the ...

Outcomes of Focal Therapy for Localized Prostate Cancer

We found that focal ablation of localized prostate cancer (PCa) is effective, with about 80% of men showing no significant cancer in ...

Evaluating efficacy of targeted microwave ablation in ...

Following the procedure, a reduction in prostate-specific antigen (PSA) was recorded in 83% of the cases [95%CI 0.37, 0.98], implying a high ...

Pilot Study to Assess Safety and Clinical Outcomes of ...

Conclusions. Prostate gland ablation with irreversible electroporation is feasible and safe in selected men with localized prostate cancer. Intermediate-term ...

A systematic review of outcomes after thermal and ...

At 6 months, 23% of patients had an in-field recurrence, and 7% had cancer outside of the ablated region. There were no serious adverse events, and ...

Irreversible Electroporation for Prostate Tissue Ablation in ...

The data from this study demonstrated that the NanoKnife System can be used successfully and safely for prostate tissue ablation in patients ...

Extended Focal Ablation of Localized Prostate Cancer With ...

Of the 100 patients with 6-month follow-up, percentage change in IPSS from baseline to 6 months was 50.0%, and only 9 patients (9%; 95% CI, 4.2 ...