225 Participants Needed

Ablative Therapy for Prostate Cancer

SG
Overseen BySonobia Garrett
Age: 18+
Sex: Male
Trial Phase: Academic
Sponsor: University of Texas Southwestern Medical Center
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 aims to test the effectiveness and safety of different ablative therapies for treating localized prostate cancer, which remains confined to the prostate. It will explore how these treatments impact both cancer control and patients' quality of life. The treatments include methods such as freezing the cancer (cryoablation), using electrical pulses (irreversible electroporation), and focused ultrasound techniques. Men diagnosed with prostate cancer through a biopsy, with no spread outside the prostate, might be suitable candidates for this trial.

As a Phase 2 trial, this research focuses on measuring how well the treatment works in an initial, smaller group of people, offering participants a chance to contribute to important advancements in prostate cancer care.

Will I have to stop taking my current medications?

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 these ablative therapies are safe for managing localized prostate cancer?

Research has shown that treatments like cryoablation (freezing tissue) and high-intensity focused ultrasound (HIFU) are safe for treating prostate cancer. Patients usually tolerate these treatments well, and they have low complication rates.

Studies have found that HIFU is a minimally invasive method that targets and heats cancer cells without causing major side effects. Early evidence suggests it is a safe choice for men with localized prostate cancer, with most patients not experiencing severe problems after treatment.

Cryotherapy, which involves freezing cancer cells, is another safe option for prostate cancer patients. It is also minimally invasive and aims to protect healthy tissues.

Overall, current research indicates these treatments are generally safe. However, like any medical procedure, risks exist, so discussing them with a healthcare provider is important.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about ablative therapy for prostate cancer because it offers a targeted approach that minimizes damage to surrounding tissues. Unlike traditional treatments like surgery or radiation, ablative therapy uses methods such as cryoablation, irreversible electroporation, and high intensity focused ultrasound to destroy cancer cells with precision. A standout feature is the novel MRI-guided transurethral ultrasound ablation (TULSA), which allows for real-time imaging and precise targeting of the tumor. This means potentially fewer side effects and a quicker recovery time for patients, making it a promising option in prostate cancer care.

What evidence suggests that ablative therapies are effective for localized prostate cancer?

Research has shown that certain treatments can be effective for localized prostate cancer. In this trial, participants will receive ablative therapies, which may include high-intensity focused ultrasound (HIFU), cryotherapy, irreversible electroporation (IRE), or MRI-guided transurethral ultrasound ablation (TULSA), based on the investigators' discretion. HIFU has demonstrated promising results, with many patients remaining cancer-free in the treated areas. Cryotherapy also appears to be a good option. Newer treatments like IRE and TULSA aim to target cancer cells more precisely. These methods may improve quality of life and cause fewer side effects than traditional treatments. Overall, these therapies offer hope for controlling cancer effectively with fewer complications.46789

Who Is on the Research Team?

XM

Xiaosong Meng, MD, PhD

Principal Investigator

University of Texas Southwestern Medical Center

Are You a Good Fit for This Trial?

Inclusion Criteria

Ability to understand and the willingness to sign a written informed consent.
Men with histologically confirmed prostate adenocarcinoma diagnosed on prostate biopsy
Men with histologically confirmed local recurrence of prostate cancer diagnosed on prostate biopsy and standard of care imaging excluding locoregional or metastatic disease
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo ablative therapies such as cryoablation, IRE, HIFU, or TULSA as part of their standard of care treatment

Single outpatient session lasting 2-4 hours
1 visit (in-person)

Follow-up

Participants are monitored for safety, urinary function, erectile function, and oncologic outcomes

12 months
Multiple visits over 12 months

Long-term follow-up

Participants are monitored for long-term oncologic outcomes and adverse events

3 years

What Are the Treatments Tested in This Trial?

Interventions

  • Ablative Therapy

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Ablative TherapyExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials
1,102
Recruited
1,077,000+

Citations

Survival and quality of life outcomes of high-intensity ...

To evaluate the survival and quality of life (QoL) outcomes of high-intensity focused ultrasound (HIFU) whole-gland ablation for localized prostate cancer.

Prostate Cancer

Learn how focused ultrasound could transform the quality of life and decrease the cost of care for patients with Prostate Cancer.

Cryotherapy, HIFU, and Other Ablative Treatments for ...

Some types of ablative treatments, such as cryotherapy and high-intensity focused ultrasound (HIFU), might be options to treat prostate cancer ...

Review article Advances in focal therapy for prostate cancer

FT includes a variety of ablative techniques, such as high-intensity focused ultrasound (HIFU), cryotherapy, irreversible electroporation ...

Outcomes of Recent Clinical Trials for Focal Therapy

Two-year data from the ExAblate system, utilizing MRI-guided transrectal HIFU, report high cancer-free rates within treatment zones and overall glands while ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/36736917/

Real-World Comparative Safety and Effectiveness of ...

Both IRE and HIFU were found to produce favorable effectiveness outcomes and have low complication rates while minimally impacting patient ...

MED.00057 MRI Guided High Intensity Focused ...

This document addresses magnetic resonance imaging (MRI) guided high intensity focused ultrasound (HIFU) ablation, also known as magnetic resonance guided ...

High Intensity Focused Ultrasound - Medical Clinical Policy ...

The authors concluded that early evidence suggests that partial gland ablation is a safe treatment option for men with localized disease. Longer term data ...

High Intensity Focused Ultrasound (HIFU)

High intensity focused ultrasound (HIFU) is a minimally invasive surgical technique for the thermal ablation of both malignant and benign tumors ...