Microwave Ablation + Prostate Resection for Prostate Cancer

Recruiting in Palo Alto (17 mi)

Overseen by Andre Luis Abreu, MD

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Southern California

Must not be taking: Androgen deprivation therapy

Disqualifiers: Prostate surgery, Radiotherapy, Pelvic trauma, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This phase I trial tests the safety of magnetic resonance imaging (MRI)/ ultrasound (US) fusion guided transperineal targeted microwave ablation (TMA) before a radical prostatectomy (RP) and how well it works in treating patients with prostate cancer. Prostate cancer is the second most common cancer in men and most will never become aggressive. Despite this, most men choose to undergo treatment which may include surgery. Removing the prostate gland and sometimes the lymph nodes (radical prostatectomy) is an invasive treatment for prostate cancer that can have a significant negative on quality of life. TMA is a less invasive procedure that uses high temperatures given through the skin between the scrotum and the rectum (transperineal). Using focused high energy and heating tumor cells to several degrees above normal body temperature may kill them without affecting the surrounding tissue. Using multiparametric (mp)MRI/US to create a 3-dimensional picture of the tumor may help in planning and preventing damage to healthy tissue. Giving MRI/US fusion guided transperineal TMA prior to radical prostatectomy may kill tumor cells, and may improve the quality of life in patients with prostate cancer.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have had past treatments for prostate cancer, you may not be eligible to participate.

What data supports the effectiveness of the treatment Microwave Ablation + Prostate Resection for Prostate Cancer?

Robot-assisted radical prostatectomy (RARP), a component of the treatment, is considered one of the best options for localized prostate cancer and may offer quality of life benefits over open surgery. It is also increasingly used and found to be favorable in frailer populations, suggesting its effectiveness and adaptability. ^{1 2 3 4 5}

Is microwave ablation safe for treating prostate conditions?

Research on microwave ablation for prostate conditions, like benign prostatic hyperplasia (BPH) and prostate cancer, shows it is generally safe with modest side effects. Studies have evaluated different systems and protocols, indicating that while the treatment is minimally invasive, follow-up is important to monitor long-term safety. ^{6 7 8 9 10}

How does the treatment Microwave Ablation + Prostate Resection for Prostate Cancer differ from other treatments?

This treatment combines microwave ablation, which uses heat to destroy cancer cells, with prostate resection, a surgical removal of the prostate. It is unique because it targets cancer cells with heat while also removing the prostate, potentially offering a more comprehensive approach than treatments that only use one method. ^{11 12 13 14 15}

Eligibility Criteria

Men with prostate cancer who have chosen surgery as their treatment and whose tumors can be seen on an MRI. They must be able to undergo sedation or anesthesia for the procedure, and agree to participate by signing a consent form.

Inclusion Criteria

Index lesion visible on multiparametric MRI confirmed by targeted biopsies using KOELIS Trinity (registered trademark)

I am a man with prostate cancer and will have surgery to remove my prostate.

Free, informed, and written consent, dated and signed before the enrollment and before any exam required by the trial

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Planning

Patients undergo planning mpMRI of prostate prior to TMA

1 week

1 visit (in-person)

Treatment

Patients undergo MRI/US fusion guided transperineal targeted TMA and then undergo standard of care radical prostatectomy (RP) same day or at 30 days post-TMA

1 day to 30 days

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of erectile and urinary functions

4 weeks

2 visits (in-person)

Treatment Details

Interventions

• Microwave Ablation (Procedure)
• Radical Prostatectomy (Procedure)

Trial Overview The trial is testing if using targeted microwave ablation (TMA) before removing the prostate gland helps treat prostate cancer better. TMA is less invasive, uses heat to kill tumor cells, and aims to preserve healthy tissue with the help of advanced imaging techniques.

Participant Groups

Group I: Treatment (TMA, radical prostatectomy) Experimental Treatment 5 Interventions

Patients undergo MRI/US fusion guided transperineal targeted TMA and then undergo standard of care RP same day or at 30 days post-TMA on study. Patients may undergo planning mpMRI of prostate prior to TMA. Patients also undergo blood sample collection at screening and post RP.

Microwave Ablation is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Microwave Ablation for:

• Colorectal cancer liver metastases
• Unresectable liver lesions
• Small solitary lesions

🇪🇺 Approved in European Union as Microwave Ablation for:

• Colorectal cancer liver metastases
• Unresectable liver lesions
• Small solitary lesions

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

USC / Norris Comprehensive Cancer Center Los Angeles, CA

Who Is Running the Clinical Trial?

University of Southern California Lead Sponsor

National Cancer Institute (NCI) Collaborator

References

1. United States pubmed.ncbi.nlm.nih.gov

Minimally invasive surgical approaches and management of prostate cancer. [2008] For clinically localized prostate cancer, radical prostatectomy remains the "gold standard" treatment. New forms of minimally invasive therapies are sought out by patients, however, because of the potential morbidity associated with open surgery. With quality-of-life aspects influencing patient decision making, minimally invasive therapeutic modalities have generated great interest among patients. Laparoscopic radical prostatectomy, robotic-assisted laparoscopic prostatectomy, brachytherapy, cryotherapy, and high-intensity focused ultrasound are all considered to be minimally invasive treatment options for the management of clinically localized prostate cancer.

2. England pubmed.ncbi.nlm.nih.gov

Robot-assisted laparoscopic radical prostatectomy after previous open transvesical adenomectomy. [2018] Robot-assisted laparoscopic radical prostatectomy (RALRP) is one of the best treatment for patients with localized prostate cancer. RALRP is currently performed in patients without previous surgical treatment for benign prostatic hyperplasia. This paper presents a successfully performed RALRP after previous open transvesical adenomectomy (TVA).

3. Switzerland pubmed.ncbi.nlm.nih.gov

Biochemical recurrence after robot-assisted radical prostatectomy in a European single-centre cohort with a minimum follow-up time of 5 years. [2021] Robot-assisted radical prostatectomy (RARP) is an increasingly commonly used surgical treatment option for prostate cancer (PCa); however, its longer-term oncologic results remain uncertain.

4. Netherlands pubmed.ncbi.nlm.nih.gov

Differences in Quality of Life between German and Dutch Patients with Prostate Cancer Treated with Robot-assisted Radical Prostatectomy: Implications for International Multicenter Randomized Controlled Trials. [2023] As a local treatment for prostate cancer (PCa), robot-assisted radical prostatectomy (RARP) may have a quality of life (QoL) benefit over open surgery. Recent analyses revealed substantial between-country differences in the function and symptom scale scores for the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30), which is typically used to assess patient-reported QoL. Such differences could have implications for multinational studies in PCa.

5. England pubmed.ncbi.nlm.nih.gov

Robotic-assisted radical prostatectomy is pushing the boundaries: a national survey of frailty using the national surgical quality improvement program. [2023] Robotic-assisted radical prostatectomy (RARP) has been found to be comparable and, in some cases, favorable to open surgical approaches, while being used in a frailer population.

6. United States pubmed.ncbi.nlm.nih.gov

Transperineal microwave thermoablation in patients with obstructive benign prostatic hyperplasia: a phase I clinical study with a new mini-choked microwave applicator. [2016] To evaluate the tolerability and safety of a newly designed probe for trans-perineal microwave thermoablation (TPMT) of the prostate in patients with benign prostatic hyperplasia (BPH), and the in vivo microwave effects on prostatic tissue.

7. Switzerland pubmed.ncbi.nlm.nih.gov

Tolerability of 3.5 versus 2.5 high-energy transurethral microwave thermotherapy. [2018] To evaluate the tolerability of high-energy microwave thermotherapy in patients with benign prostatic hyperplasia (BPH) using two different treatment protocols (Prostasoft 2.5 and Prostasoft 3.5).

8. England pubmed.ncbi.nlm.nih.gov

Long-term clinical outcome of transurethral microwave thermotherapy (TUMT) 1991-1999 at Karolinska Hospital, Sweden. [2004] Minimal invasive methods, such as transurethral microwave thermotherapy (TUMT), are economical and have modest side effects compared with transurethral electro-resection of the prostate (TUR-P). The treatment results from different TUMT-systems vary. Follow-up studies on each system type are therefore necessary. The objectives of this study are to summon the long-term clinical results of our TUMT-system and search for a pre-treatment parameter that can measure responding patients.

9. United States pubmed.ncbi.nlm.nih.gov

A novel transurethral microwave thermal ablation system to treat benign prostatic hyperplasia: results of a prospective multicenter clinical trial. [2006] We evaluated the efficacy, safety and impact on quality of life of a newly designed microwave thermal ablation system in patients with benign prostatic hyperplasia (BPH).

10. England pubmed.ncbi.nlm.nih.gov

Microwave focal therapy of prostate cancer: a non-clinical study and exploratory clinical trial. [2022] To examine the safety and efficacy of microwave tissue coagulation (MTC) for prostate cancer and assess its use in lesion-targeted focal therapy in a non-clinical study and a clinical phase II trial.

11. England pubmed.ncbi.nlm.nih.gov

Transperineal Targeted Microwave Ablation (TMA) of localized prostate cancer guided by MRI-Ultrasound fusion and organ-based tracking: a pilot study. [2023] To investigate the efficacy of transperineal targeted microwave ablation (TMA) in treating localized prostate cancer (PCa).

12. Japan pubmed.ncbi.nlm.nih.gov

[Histopathological changes due to transurethural microwave thermotherapy associated with androgen deprivation therapy in patients with localized prostate cancer]. [2019] The 2nd generation transurethral microwave thermotherapy (TUMT), equipped with high energy microwave generator and urethral cooling device is widely accepted as an less invasive effective modality to treat benign prostatic hyperplasia. For prostatic cancer, however, it is generally estimated as insufficient because of limitation in penetration of microwave into deep prostatic tissue. In this study, we examined histopathologic changes after androgen deprivation theraphy (ADT) and TUMT.

13. United States pubmed.ncbi.nlm.nih.gov

High energy thermotherapy versus transurethral resection in the treatment of benign prostatic hyperplasia: results of a prospective randomized study with 1 year of followup. [2006] We compared the outcome of transurethral resection of the prostate and high energy microwave thermotherapy in patients with benign prostatic hyperplasia.

14. United States pubmed.ncbi.nlm.nih.gov

Does transurethral microwave thermotherapy have a different effect on prostate cancer than on benign or hyperplastic tissue? [2019] Transurethral microwave thermotherapy is useful for the treatment of benign prostatic hyperplasia, but its effect on cancer is not documented. We analyzed the pathologic changes occurring after microwave thermotherapy in whole mount radical prostatectomy specimens from patients with cancer.

15. Norway pubmed.ncbi.nlm.nih.gov

[Single transurethral microwave therapy of benign prostatic hyperplasia]. [2008] We have used transurethral microwave thermotherapy in the treatment of benign prostatic hyperplasia since October 1991. Irreversible cell damage occurs when the microwaves heat the periurethral prostatic tissue. The urethra is simultaneously cooled, and is not destroyed during treatment. The patients are not hospitalized. Transurethral microwave thermotherapy is performed under local anaesthesia, no other form of analgesia has been found necessary. We have included patients with symptomatic prostatic obstruction who would otherwise have received operative or pharmacologic treatment. Patients with high residual urine, large middle lobe, urethral stricture, prostatic cancer, decreased renal function, urinary infection or metal implants were excluded. We observed a marked improvement in the Madsen symptom score after transurethral microwave thermotherapy. The score decreased from 12 before treatment to five after six weeks and 4.6 after six months (p