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NCT Number: NCT02303054

MRI-Targeted Focal Ablation of the Prostate in Men With Prostate Cancer

This is a prospective single center trial to examine the rate of negative biopsy result and quality of life after focal ablation by radiofrequency energy. The primary evaluation involves assessing the rate of negative biopsy result using MR-US fusion biopsy six months after focal ablation of the prostate. Urinary and sexual quality of life will be assessed through validated measures. The hypothesis of our study is that focal ablative therapy will result in a greater likelihood of negative biopsy on followup biopsy than that observed in men who elect not to undergo therapy.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

40 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Smilow Comprehensive Prostate Cancer Center

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Subject Population:

  • Men 40-80 years of age
  • Diagnosis of adenocarcinoma of the prostate, confirmed by TransRectal Ultrasound (TRUS) biopsy
  • No prior treatment for prostate cancer
  • Prostate Cancer Clinical Stage T1c
  • Prostate-specific antigen (PSA)<10 ng/ml (this will be the PSA level prompting the initial prostate biopsy)
  • Declined all standard treatment options

Pre-enrollment biopsy parameters:

  • Minimum of 12 biopsy cores
  • Gleason 6 (3+3) or 7 (3+4)

Final enrollment biopsy parameters after fusion biopsy:

  • 12 standard biopsy cores plus targeted regions based upon MRI
  • Gleason 6 (3+3) or 7 (3+4)
  • No demonstrated cancer diameter >1.2 cm

Exclusion criteria

  • Histology other than adenocarcinoma
  • Biopsy does not meet inclusion criteria
  • History of transurethral resection of prostate (TURP) or other similar procedures transurethral microwave therapy (TUMT), transurethral needle ablation (TUNA)
  • History of prior pelvic radiation
  • Men who have received any hormonal manipulation (antiandrogens; luteinizing hormone-releasing hormone (LHRH)-agonist; 5-alpha-reductase inhibitors) within the previous 12 months
  • Contraindication for Multiparametric-MRI

Treatment and study plan

Bipolar Radiofrequency Focal Ablation

Procedure

Men identified as having suspicious regions on a pre-biopsy mpMRI will be considered for enrollment. Following an MRI-US targeted biopsy of the prostate, men testing positive will be eligible for enrollment. All men enrolled in the study will undergo focal radiofrequency ablation and evaluated in follow-up.

Primary outcomes

  1. Number of Subjects Resulting in Negative Biopsy as a Measure of Efficacy

    Time frame: 6 months after focal bipolar radiofrequency ablation (RFA)

    The primary endpoint of the trial will be assessed at 6 months after focal bipolar RFA by repeat mp-MRI imaging and fusion biopsy. Treatment efficacy, defined as a negative, will be determined by the results of the MRI-US targeted biopsy that will include regions treated by focal bipolar RFA.

Secondary outcomes

  1. International Prostate Symptom Score to Measure Quality of Life Post Focal Ablation

    Time frame: 1 week; 2 week; 1 month; 3 months; 6 months

    Participants will be asked to complete international prostate symptom score (IPSS) questionnaires at each time frame to determine any baseline changes from voiding symptoms following focal RFA

  2. Expanded Prostate Cancer Index Composite (EPIC) Score to Measure Quality of Life Post Focal Ablation

    Time frame: 1 week; 2 week; 1 month; 3 months; 6 months

    Participants will be asked to complete EPIC questionnaires at each time frame to evaluate any baseline changes in patient function and bother following focal RFA

  3. International Index of Erectile Function questionnaires Score (IEFF) to Measure Quality of Life Post Focal Ablation

    Time frame: 1 week; 2 week; 1 month; 3 months; 6 months

    Participants will be asked to complete International Index of Erectile Function (IIEF) - 15 questionnaires at each time frame to evaluate any baseline changes in erectile function following focal RFA

  4. Short Form - 12 (SF-12) to Measure Quality of Life Post Focal Ablation

    Time frame: 1 week; 2 week; 1 month; 3 months; 6 months

    Participants will be asked to complete SF-12 questionnaires at each time frame to evaluate any baseline changes in functional health and well-being

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • Trod Medical N.V.

Registry information

Official study title

Magnetic Resonance (MR)-US Fusion Biopsy-Guided Focal Bipolar Radio-Frequency Ablation of the Prostate in Men With Localized Prostate Cancer (FUSAblate Trial)

Acronym: FUSAblate

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Nov 27, 2014
Registry last updated
Oct 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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