Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Symptoms and General Pathology

Wounds and Injuries

Carcinoma

Carcinoma, Papillary

Carcinoma in Situ

Urinary Bladder Neoplasms

Hyperthermia

Fever

Non-Muscle Invasive Bladder Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Neoplasms, Squamous Cell

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Mitomycins

Mitomycin

BCG Vaccine

Anti-Bacterial Agents

Antibiotics, Antitubercular

Alkylating Agents

Enzyme Inhibitors

Bladder radiofrequency-induced hyperthermia will be delivered in combination with each instillation of MMC in accordance with the Sponsor operational guidelines.

Subjects will receive a series of induction followed by a series of maintenance bladder instillations of Synergo® RITE + MMC

Synergo® RITE + MMC

Michael A O'Donnell, MD

This study will determine whether Synergo® RITE + MMC treatment is efficacious as second-line therapy for CIS NMIBC BCG-unresponsive patients with or without papillary NMIBC, through examination of the complete response rate (CRR) and disease-free duration for complete responders. The study will also explore progression-free survival time, bladder preservation rate, and overall survival time.

The study will address an unmet need to identify a treatment effective in both ablating the disease and providing a prolonged disease-free period for patients. Ideally, the treatment will delay progression to invasive disease, thus preserving the bladder.

Mitomycin C Intravesical Chemotherapy in Conjunction With Synergo® Radiofrequency-Induced Hyperthermia for Treatment of Carcinoma in Situ Non-Muscle Invasive Bladder Cancer Patients Unresponsive to Bacillus Calmette-Guérin, With or Without Papillary Tumors.

A Multicenter, Single-Arm Study Evaluating the Efficacy of Synergo® Radiofrequency-Induced Thermochemotherapy Effect (RITE) With Mitomycin C (Synergo® RITE + MMC) in CIS Non-Muscle Invasive Bladder Cancer (NMIBC) Bacillus Calmette-Guérin (BCG)-Unresponsive Patients With or Without Papillary NMIBC

* no CIS
* no papillary HG tumor
* no papillary T1 tumor
* no extra-vesical UC tumor
* no progression

a patient will be considered a complete responder only if all the criteria above are met.

Patients experiencing a new occurrence of a benign tumor or low-grade Ta will be allowed to continue in the study (tumor will be resected); such an occurrence will not constitute an event in the primary analysis.

Patients with tumors of the ostium and/or upper tract and/or prostatic urethra will be considered to have achieved a complete response in the primary analysis but will be removed from the study.

time of recurrence for complete response patients from the 3-month visit until the time of recurrence or until the last follow-up, whichever occurs sooner.

Medical Enterprises Ltd.

Prostatic Neoplasms

Genital Neoplasms, Male

Genital Diseases

Genital Diseases, Male

Prostatic Diseases

Central Nervous System Depressants

Anesthetics

Anesthetics, General

Treatment is performed under a spinal or general anesthetic and will include the one to three regions of the prostate containing cancer based on the mapping biopsy.

RFA is a minimally invasive procedure. It is an image-guided technique that heats and destroys cancer cells. In RFA, imaging techniques such as ultrasound or magnetic resonance imaging (MRI) are used to help guide a needle electrode into a cancerous tumor. High-frequency electrical currents are then passed through the electrode, destroying the cancer cells.

Radio-Frequency Ablation (RFA) ENCAGE™

Julio Pow-Sang, M.D.

This is a prospective pilot study. The purpose of this research study is to evaluate the safety and efficacy of focal Radio-Frequency Ablation (RFA) in men with low-risk, clinically localized prostate cancer.

RFA is a minimally invasive procedure. It is an image-guided technique that heats and destroys cancer cells. In RFA, imaging techniques such as ultrasound or magnetic resonance imaging (MRI) are used to help guide a needle electrode into a cancerous tumor. High-frequency electrical currents are then passed through the electrode, destroying the cancer cells. Use of an RFA device was approved by the Food and Drug Association (FDA) in 1997 for the purposes of treating soft tissue tumors. The device we (Moffitt Cancer Center) will be using in this study has clearance for clinical use from the FDA. The effectiveness of the device is measured using biopsy cores at the site of the cancer after the RFA procedure. To evaluate the benefits of this procedure, we will also evaluate the change in quality-of-life indicators from baseline to 6 months following RFA. RFA is being developed as a minimally invasive potential treatment for prostate cancer.

This research study is a pilot clinical trial. Pilot clinical trials are smaller versions of larger studies that are conducted to prepare for the larger study. This pilot study pre-tests a research device before a large-scale multicenter study is launched.

The specific purpose of this pilot trial is to find out if RFA can effectively treat prostate cancer with fewer side effects including effects on urination, bowel function, and sexual function. RFA for early stage prostate cancer is designed to affect only the part of the prostate where cancer has been detected. The reasoning for this approach is the smaller the area given RFA, the less damage to surrounding tissues.

Pilot Study on Focal Prostate Radio-Frequency Ablation

Pilot Study on Focal Prostate Radio-Frequency Ablation for the Treatment of Very-Low Risk Prostate Cancer

The primary efficacy endpoint is negative biopsy rate at 6 months after focal bipolar RFA. Evaluable patients for this study will be those who complete up through the six month follow-up/evaluation procedure.

Patients will complete the Expanded Prostate Cancer Index Composite (EPIC), American Urologic (AUA), Rectal Assessment Scale (RAS), and Sexual Health Inventory for Men (SHIM) questionnaires at baseline, 3 month and 6 month visits. QOL will be primarily based on the EPIC, developed to measure health related QOL among men with prostate cancer.

Trod Medical, US,LLC

H. Lee Moffitt Cancer Center and Research Institute

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Mitomycin C Intravesical Chemotherapy in Conjunction With Synergo® Radiofrequency-Induced Hyperthermia for Treatment of Carcinoma in Situ Non-Muscle Invasive Bladder Cancer Patients Unresponsive to Bacillus Calmette-Guérin, With or Without Papillary Tumors.	NCT03335059	Bladder Cancer Bladder Neoplas... Bladder Tumors Cancer of Bladd... Cancer of the B... Malignant Tumor... Neoplasms, Blad... Urinary Bladder... Carcinoma in Si... Papillary Carci... BCG-Unresponsiv...	Synergo® RITE +...	18 Years -	Medical Enterprises Ltd.
Pilot Study on Focal Prostate Radio-Frequency Ablation	NCT01423006	Prostate Cancer	Radio-Frequency...	18 Years -	H. Lee Moffitt Cancer Center and Research Institute
Pilot Study on Focal Prostate Radio-Frequency Ablation	NCT01423006	Prostate Cancer	Radio-Frequency...	18 Years -	H. Lee Moffitt Cancer Center and Research Institute
Mitomycin C Intravesical Chemotherapy in Conjunction With Synergo® Radiofrequency-Induced Hyperthermia for Treatment of Carcinoma in Situ Non-Muscle Invasive Bladder Cancer Patients Unresponsive to Bacillus Calmette-Guérin, With or Without Papillary Tumors.	NCT03335059	Bladder Cancer Bladder Neoplas... Bladder Tumors Cancer of Bladd... Cancer of the B... Malignant Tumor... Neoplasms, Blad... Urinary Bladder... Carcinoma in Si... Papillary Carci... BCG-Unresponsiv...	Synergo® RITE +...	18 Years -	Medical Enterprises Ltd.

Spots Global Cancer Trial Database for radio frequency