Microwave Ablation + Prostate Resection for Prostate Cancer

Overseen By Ileana Aldana

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: University of Southern California

Must not be taking: Androgen deprivation therapy

Disqualifiers: Prostate surgery, Radiotherapy, Pelvic trauma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 1 day to 30 days

15 Participants Needed

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}

Research Team

Andre Luis Abreu, MD

Principal Investigator

University of Southern California

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

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
• Radical Prostatectomy

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

Who Is Running the Clinical Trial?

University of Southern California

Lead Sponsor

Trials

956

Recruited

1,609,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

Radical prostatectomy is still considered the 'gold standard' treatment for clinically localized prostate cancer, but many patients are seeking minimally invasive alternatives due to concerns about the risks associated with open surgery.

Minimally invasive options like laparoscopic radical prostatectomy, robotic-assisted laparoscopic prostatectomy, brachytherapy, cryotherapy, and high-intensity focused ultrasound are gaining popularity among patients, as they may offer better quality of life outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Minimally invasive surgical approaches and management of prostate cancer. Gonzalgo, ML., Patil, N., Su, LM., et al.[2008]

Robot-assisted laparoscopic radical prostatectomy (RALRP) can be successfully performed in patients with a history of previous open transvesical adenomectomy (TVA), as demonstrated in a case involving a 68-year-old patient.

Post-surgery, the patient had a satisfactory quality of life, with undetectable prostate-specific antigen levels, although he experienced moderate stress incontinence; this suggests that previous prostate surgery does not significantly hinder the effectiveness of RALRP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robot-assisted laparoscopic radical prostatectomy after previous open transvesical adenomectomy. Bove, AM., Altobelli, E., Sergi, F., et al.[2018]

In a study of 944 men who underwent robot-assisted radical prostatectomy (RARP) for prostate cancer, the biochemical recurrence-free survival (BRFS) rate was 84.8% at a median follow-up of 6.3 years, indicating that RARP is effective in maintaining low PSA levels post-surgery.

Factors such as higher preoperative PSA levels, higher Gleason scores, pathologic T3 disease, positive surgical margins, and lower surgeon volume were linked to an increased risk of biochemical recurrence, highlighting the importance of these variables in predicting patient outcomes.

NCBI (Pubmed)

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. Sooriakumaran, P., Haendler, L., Nyberg, T., et al.[2021]

In a study of 8348 prostate cancer patients (1938 Dutch and 6410 German) treated with robot-assisted radical prostatectomy, Dutch patients reported significantly higher quality of life scores compared to German patients, indicating potential nationality-related differences in patient-reported outcomes.

Urinary continence recovery and Dutch nationality were identified as the strongest positive factors influencing quality of life scores, suggesting that these factors should be considered in multinational studies of prostate cancer treatment outcomes.

NCBI (Pubmed)

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. Wagner, C., Witt, JH., Nolte, S., et al.[2023]

A study of 66,683 patients who underwent robotic-assisted radical prostatectomy (RARP) from 2011 to 2019 showed that the procedure is increasingly being performed on older and frailer patients without an increase in postoperative morbidity or mortality.

Despite the rising frailty in the patient population, the operative time and length of hospital stay for RARP have decreased, indicating improved efficiency of the procedure over time.

NCBI (Pubmed)

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. Abou Heidar, NF., Ayoub, CH., Abou Mrad, A., et al.[2023]

The AMICA-PROBE for trans-perineal microwave thermoablation (TPMT) of the prostate was found to be safe and well-tolerated in a study of nine patients with benign prostatic hyperplasia (BPH), with no reported adverse events during or after the procedure.

TPMT effectively created well-defined quasi-spheroid lesions in prostatic tissue, indicating controlled coagulative necrosis, which suggests potential for effective treatment of BPH, although further Phase II studies are needed to assess its efficacy.

NCBI (Pubmed)

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. Bartoletti, R., Cai, T., Tinacci, G., et al.[2016]

In a study involving 80 patients with benign prostatic hyperplasia, both high-energy microwave thermotherapy protocols (Prostasoft 2.5 and 3.5) were found to be well tolerated, with no significant predictors of pain levels based on patient characteristics.

Although patients in the Prostasoft 3.5 group reported higher initial pain, their overall discomfort was similar to those in the Prostasoft 2.5 group by the end of treatment, suggesting that shorter treatment times can effectively reduce patient discomfort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tolerability of 3.5 versus 2.5 high-energy transurethral microwave thermotherapy. Francisca, EA., Kortmann, BB., Floratos, DL., et al.[2018]

In a study of 371 patients treated with transurethral microwave thermotherapy (TUMT) for benign prostate hyperplasia (BPH), approximately 76% reported benefits from the treatment, with 22% feeling fully cured after follow-up periods of 12 to 72 months.

The treatment led to a significant reduction in symptoms, with a 40% decrease in the International Prostate Symptom Score (IPSS) and a 30% improvement in Quality of Life scores, while 41% of patients who previously required a catheter became catheter-free after treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term clinical outcome of transurethral microwave thermotherapy (TUMT) 1991-1999 at Karolinska Hospital, Sweden. Ekstrand, V., Westermark, S., Wiksell, H., et al.[2004]

Microwave thermal ablation significantly reduced BPH symptoms by 56% after 12 months, improving patients' quality of life, as shown by a decrease in the American Urological Association symptom score from 20.1 to 8.8.

The procedure was safe, with minimal adverse events, and allowed for rapid recovery without the need for general anesthesia or extensive monitoring, leading to high patient satisfaction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel transurethral microwave thermal ablation system to treat benign prostatic hyperplasia: results of a prospective multicenter clinical trial. Ramsey, EW., Miller, PD., Parsons, K.[2006]

Microwave tissue coagulation (MTC) for prostate cancer showed promising safety and efficacy, with no serious adverse events reported in a clinical trial involving five patients, and only temporary urinary symptoms observed post-treatment.

All MRI-visible lesions disappeared after MTC treatment, and prostate-specific antigen (PSA) levels decreased by 55% six months later, indicating effective lesion-targeted therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Microwave focal therapy of prostate cancer: a non-clinical study and exploratory clinical trial. Boku, H., Kaneko, M., Yamada, Y., et al.[2022]

Transperineal targeted microwave ablation (TMA) demonstrated high efficacy in treating localized prostate cancer, with 91.3% of treated areas showing no cancer in follow-up biopsies after 6 months.

The procedure was found to be safe, with manageable complications and no significant changes in urinary symptoms, erectile function, or quality of life scores for most patients, indicating it is a viable treatment option for men with localized prostate cancer.

NCBI (Pubmed)

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. Chiu, PK., Chan, CH., Yee, CH., et al.[2023]

In a study of 10 patients with localized prostate cancer, a combination of androgen deprivation therapy (ADT) and transurethral microwave thermotherapy (TUMT) led to a significant reduction in prostate volume from an average of 37.4 ml to 22.0 ml after 3 months.

Pathological analysis of tissue samples after TUMT showed progressive fibrotic changes and no viable cancer cells in 9 out of 10 patients, suggesting that this treatment approach may effectively reduce cancer presence, although one patient still had some cancerous tissue remaining.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Histopathological changes due to transurethural microwave thermotherapy associated with androgen deprivation therapy in patients with localized prostate cancer]. Jujo, Y., Koshiba, K., Suzuki, R., et al.[2019]

In a study of 52 patients with benign prostatic hyperplasia, both transurethral resection of the prostate and high energy microwave thermotherapy significantly improved symptoms, with a 78% improvement in the resection group compared to 68% in the thermotherapy group after one year.

Both treatments were safe, with no serious complications reported, and they provided similar levels of relief from bladder outlet symptoms, indicating that microwave thermotherapy is a viable alternative to traditional surgery.

NCBI (Pubmed)

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. D'Ancona, FC., Francisca, EA., Witjes, WP., et al.[2006]

Transurethral microwave thermotherapy effectively induces hemorrhagic necrosis in prostate tissue, including cancerous areas, with minimal damage to the urethra, as observed in a study of nine patients undergoing radical prostatectomy after treatment.

The study found that while significant necrosis occurred shortly after treatment (up to 39% of the prostate), the effects diminished over time, with minimal necrosis remaining after 12 months, indicating a potential for tissue recovery and reabsorption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does transurethral microwave thermotherapy have a different effect on prostate cancer than on benign or hyperplastic tissue? Khair, AA., Pacelli, A., Iczkowski, KA., et al.[2019]

Transurethral microwave thermotherapy effectively reduces symptoms of benign prostatic hyperplasia, with significant improvements in the Madsen symptom score from 12 to 4.6 after six months, indicating better urinary function.

The procedure is performed under local anesthesia without hospitalization, but 13% of patients experienced postoperative urinary retention, highlighting the need for monitoring after treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Single transurethral microwave therapy of benign prostatic hyperplasia]. Sand, TE., Sander, S., Holme, P., et al.[2008]

References

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

Minimally invasive surgical approaches and management of prostate cancer. [2008]

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

Robot-assisted laparoscopic radical prostatectomy after previous open transvesical adenomectomy. [2018]

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]

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]

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]

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]

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

Tolerability of 3.5 versus 2.5 high-energy transurethral microwave thermotherapy. [2018]

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

Long-term clinical outcome of transurethral microwave thermotherapy (TUMT) 1991-1999 at Karolinska Hospital, Sweden. [2004]

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]

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

Microwave focal therapy of prostate cancer: a non-clinical study and exploratory clinical trial. [2022]

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]

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]

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]

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]

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

[Single transurethral microwave therapy of benign prostatic hyperplasia]. [2008]