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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment approach for prostate cancer, combining a less invasive method called microwave ablation (also known as Microwave Thermosphere Ablation or Percutaneous Microwave Ablation) with traditional surgery. The researchers aim to determine if using high temperatures to target and kill cancer cells before surgery can improve quality of life by reducing the need for more invasive procedures. This approach may benefit men diagnosed with prostate cancer who plan to have their prostate removed and have a tumor visible on a special MRI scan. Participants must not have had previous prostate surgery or treatments like radiation. As an unphased trial, this study provides an opportunity to explore innovative treatment options that could enhance quality of life for prostate cancer patients.

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 prior data suggests that this technique is safe for prostate cancer treatment?

Research has shown that microwave ablation, a treatment using heat to destroy tumor cells, is safe and well-tolerated for prostate cancer patients. One study found this method effective for those with low to intermediate-risk prostate cancer, with most patients experiencing significant improvements without major side effects. Another study confirmed the treatment's accuracy and safety for patients whose cancer hasn't spread.

Regarding radical prostatectomy, the surgical removal of the prostate, research indicates it is generally safe with few complications. Some studies suggest that robotic assistance during this surgery may reduce the risk of issues like urinary incontinence. Overall, both treatments have demonstrated a good safety record in studies, making them promising options for those considering clinical trials. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the combination of Microwave Ablation (TMA) and Radical Prostatectomy (RP) for prostate cancer because it brings a new approach to treatment. Unlike traditional methods, such as surgery or radiation therapy alone, this combination uses MRI/US fusion guided technology to precisely target and destroy cancer cells with microwaves before performing surgery. This dual approach could potentially reduce the size of the tumor before removal, leading to better outcomes and preserving more healthy tissue. Additionally, the integration of advanced imaging and ablation technology aims to enhance the precision and effectiveness of prostate cancer treatment.

What evidence suggests that this trial's treatments could be effective for prostate cancer?

Research has shown that microwave ablation (MWA), one of the treatments studied in this trial, can effectively treat localized prostate cancer. In one study, it successfully treated 83% of the cancerous tissue, removing most of the cancer without leaving any at the tumor's edge. Another study found that MWA provided excellent cancer control for up to a year with few complications. These results suggest that MWA can accurately target and treat prostate cancer cells.

Radical prostatectomy, another treatment option in this trial, involves the surgical removal of the prostate gland and is a well-known treatment with a high success rate for prostate cancer. It is particularly effective when the cancer hasn't spread beyond the prostate. This surgery can help ensure complete cancer removal, although it is more invasive than MWA. Both treatments in this trial aim to effectively manage prostate cancer, with MWA being less invasive and radical prostatectomy offering a more comprehensive solution. ^{4 6 7 8 9}

Who Is on the Research Team?

Andre Luis Abreu, MD

Principal Investigator

University of Southern California

Are You a Good Fit for This Trial?

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)

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

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

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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 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]

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]

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]

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]

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]

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]

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]

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 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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39689992/

Final Results from the First Phase 2 Trial (TMA-HK) Our results show that this treatment achieved excellent local control of the cancer up to 12 months, with a low rate of complications.

2. clinicalimagingscience.org clinicalimagingscience.org/early-outcomes-with-single-antenna-high-powered-percutaneous-microwave-ablation-for-primary-and-secondary-hepatic-malignancies-safety-effectiveness-and-predictors-of-ablative-failure/

Safety, Effectiveness, and Predictors of Ablative Failure A complete ablation rate of 83% was achieved with only 17 of the 100 lesions showing residual disease (at the margin of the index tumor) using m ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11685167/

Targeted microwave ablation of localised prostate cancer These preliminary results suggest that TMA using OBT fusion is precise and safe in patients with intermediate risk localised prostate cancer.

4. member.myhealthtoolkitks.com member.myhealthtoolkitks.com/web/public/brands/medicalpolicy/external-policies/microwave-tumor-ablation/

Microwave Tumor Ablation In the RCT, overall local recurrence-free survival at 3 years was 91.3% for MWA and 96.0% for partial nephrectomy (p = 0.54). This positive outcome should be ...

5. tandfonline.com tandfonline.com/doi/full/10.1080/02656736.2021.1991012

Full article: Shaping the future of microwave tumor ablation This paper presents a review of the industry-standard commercially available MWA technology, its clinical applications, and its limitations

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12373074/

Clinical trial evaluating the efficacy and safety of percutaneous ... Safety and feasibility of transperineal targeted microwave ablation for low-to intermediate-risk prostate cancer. Eur Urol Open Sci 2022;46 ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2589004225004365

Advancements in microwave ablation for tumor treatment ... This review examines the current research on MWA's technical innovations, clinical applications, and its potential in improving cancer treatment efficacy.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12017980/

Advancements in microwave ablation for tumor treatment ... Targeted perineal MWA is safe, feasible, and well-tolerated in patients with moderate to low-risk prostate cancer. Most patients report significant improvements ...

9. urologytimes.com urologytimes.com/view/targeted-microwave-ablation-shows-precision-safety-in-localized-prostate-cancer

Targeted microwave ablation shows precision, safety in ... Targeted microwave ablation (TMA) using organ-based tracking (OBT) fusion is precise and safe in patients with intermediate-risk prostate cancer.