Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Trod Medical N.V. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
The main purpose of this study is to evaluate the safety and efficacy of focal (targeted) Radio-Frequency Ablation (RFA) in men with low or intermediate-risk, clinically localized prostate cancer.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radio-Frequency Ablation (RFA) | Experimental | Focal Prostate Radio-Frequency Ablation (RFA). Focal bipolar RFA followed by clinical follow-up visits at 6 weeks, 3 months and 6 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radio-Frequency Ablation (RFA) | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Negative Biopsy Rate at 6 Months After Focal Bipolar Radio-Frequency Ablation (RFA) | The primary efficacy endpoint is negative biopsy rate at 6 months after focal bipolar RFA. The point estimate and its 95% confidence interval will be calculated using the exact binominal method. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Related Adverse Events | The type of event using NCI Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0 will be identified and graded for severity. The relationship of the adverse event to the therapy or procedure will be determined as follows: Unrelated; Unlikely; Possible; Probable; Definite. For reporting purposes, an adverse event is considered unexpected when either the type of event or severity of the event is not listed in the study consent. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Julio Pow-Sang, M.D. | H. Lee Moffitt Cancer Center and Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| H. Lee Moffitt Cancer Center and Research Institute | Tampa | Florida | 33612 | United States |
Not provided
Six participants were enrolled at Moffitt Cancer Center, August 2015 through July 2017.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Experimental: Radio-Frequency Ablation (RFA) Focal Prostate Ra | Focal Prostate Radio-Frequency Ablation (RFA). Focal bipolar RFA followed by clinical follow-up visits at 6 weeks, 3 months and 6 months. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Experimental: Radio-Frequency Ablation (RFA) Focal Prostate Ra | Focal Prostate Radio-Frequency Ablation (RFA). Focal bipolar RFA followed by clinical follow-up visits at 6 weeks, 3 months and 6 months. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Negative Biopsy Rate at 6 Months After Focal Bipolar Radio-Frequency Ablation (RFA) | The primary efficacy endpoint is negative biopsy rate at 6 months after focal bipolar RFA. The point estimate and its 95% confidence interval will be calculated using the exact binominal method. | All participants. | Posted | Count of Participants | Participants | 6 months |
|
|
2 years
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Experimental: Radio-Frequency Ablation (RFA) Focal Prostate Ra | Focal Prostate Radio-Frequency Ablation (RFA). Focal bipolar RFA followed by clinical follow-up visits at 6 weeks, 3 months and 6 months. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hematuria | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
Accrual ended prior to reaching the study goal due to equipment needing repairs.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Julio M. Pow-Sang | H. Lee Moffitt Cancer Center and Research Institute | 813-745-2226 | julio.powsang@moffitt.org |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 12, 2015 | Aug 31, 2018 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D000230 | Adenocarcinoma |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000078703 | Radiofrequency Ablation |
| ID | Term |
|---|---|
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Up to 9 months |
| Completion of Quality of Life (QOL) Assessment Questionnaires at Six Months | The secondary objective is to evaluate the change from baseline in quality-of-life indicators following focal RFA in patients with low-risk localized prostate cancer. The patients will complete the Expanded Prostate Cancer Index Composite (EPIC), American Urological Association (AUA), Rectal Assessment Scale (RAS), and International Index of Erectile Function (IIEF-5) questionnaires at baseline and 6-month visit. EPIC scores overall 1 (dissatisfied) - 5 (extremely satisfied). AUA scores are o (no prostate issues) - 35 (very severe prostate symptoms). SHIM scores 0 (severe sexual dysfunction) - 25 (no sexual dysfunction) and RAS scores 0 (no bowel issues) - 15 (bad bowel habits) | 6 months |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
|
| Secondary | Number of Participants With Treatment Related Adverse Events | The type of event using NCI Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0 will be identified and graded for severity. The relationship of the adverse event to the therapy or procedure will be determined as follows: Unrelated; Unlikely; Possible; Probable; Definite. For reporting purposes, an adverse event is considered unexpected when either the type of event or severity of the event is not listed in the study consent. | All participants. | Posted | Count of Participants | Participants | Up to 9 months |
|
|
|
| Secondary | Completion of Quality of Life (QOL) Assessment Questionnaires at Six Months | The secondary objective is to evaluate the change from baseline in quality-of-life indicators following focal RFA in patients with low-risk localized prostate cancer. The patients will complete the Expanded Prostate Cancer Index Composite (EPIC), American Urological Association (AUA), Rectal Assessment Scale (RAS), and International Index of Erectile Function (IIEF-5) questionnaires at baseline and 6-month visit. EPIC scores overall 1 (dissatisfied) - 5 (extremely satisfied). AUA scores are o (no prostate issues) - 35 (very severe prostate symptoms). SHIM scores 0 (severe sexual dysfunction) - 25 (no sexual dysfunction) and RAS scores 0 (no bowel issues) - 15 (bad bowel habits) | Posted | Median | Full Range | score on a scale | 6 months |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 6 |
| 6 |
| Other - Blood in semen | Reproductive system and breast disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Urinary tract pain | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Fever | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Urinary frequency | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Urinary urgency | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Erectile dysfunction | Reproductive system and breast disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Other - sciatica | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Other - prostate sensitivity | Reproductive system and breast disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Non-cardiac chest pain | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Renal and urinary disorders - Other, nocturia | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Sinuusitis | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Renal and urinary disorders - Other Dysuria | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Renal and urinary disorders - Other, Burning sensation while urinating | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| RAS score |
|
| EPIC score - Overall Satisfaction |
|