Cancer of the Prostate, Neoplasms Prostate
Conditions
Keywords
Prostate, PSA, FUSION, Ultrasound, MRI, Cancer, Laser, Outcomes, Recurrence, QOL, Quality of Life, Urinary function, Sexual Function
Brief summary
This serves as a registration trial. It aims to record short, intermediate, and long-term outcomes of patients treated with targeted laser ablation of biopsy confirmed prostate cancer. Outcomes will be categorized as: 1- Procedure Related, 2- Perioperative - Adverse Events that may occur within 90 days, 3-Oncologic: Recurrence of cancer in treatment area, de-novo tumors, conversion to radical surgery, radiation or cryoablation, emergence of metastasis, 4- Functional: Sexual and Urinary function following treatment
Detailed description
CLINICAL REGISTRY OBSERVATION NATURE This serves as a registration trial evaluating short, intermediate, and long-term outcomes of patients treated with targeted laser ablation of biopsy confirmed prostate cancer. The primary outcome measure is 1-year oncological control of the targeted ablated area. The following secondary aims are sought: PROCEDURE RELATED: tolerability, feasibility, pain during this office-based procedure. PERIOPERATIVE: Adverse Events (AEs) and Series AEs profile during the initial 90 days after the procedure. ONCOLOGIC - In addition to primary aim, determine risk and rate of emergence of de-novo tumors (so called Outfield Recurrence) at the 1 year fusion biopsy mark and overtime. Will also observe rate of progression locally and systemically. Conversion to whole gland treatment - surgery extraction, radiation or whole gland cryoablation is of particular interest as is the initiation of androgen suppression (castration). Moreover, the investigators will evaluate the impact of MRI in assessing tumor locations and of software registration guiding the location and extent of ablation of the laser ablation over fixed time intervals. Finally, incidence of metastatic disease - non castrate and castrate - as well as cancer specific and overall survival at 5, 10 and 15 years post procedure. FUNCTIONAL OUTCOMES - determine urinary function and sexual function including incidence of ejaculation, and climacturia at months 3, 6 and 12. These outcomes will then measured yearly for the extent of the study
Interventions
DEVICEImage Fusion (MR/US) Software Registration Guided Laser Ablation of Prostate Cancer
Subjects diagnosed by a transperineal fusion or random transperineal or random transrectal prostate biopsy. Laser treatment plan generated by biopsy results +/- MRI is uploaded into the device. In procedure suite, a transperineal anesthetic block is conducted following by Bianco - USPTO PCT/US18/24404. On lithotomy a transrectal ultrasound probe is advanced, the prostate scanned. The images are acquired by fusion device. Co-registration is performed by surgeon delimiting boundaries of prostate. Medical device delivers real-time fusion guidance outlining prostate contours, ablation goals and laser introduce location. Surgeon executes plan or adjust as needed. Surgeon activates laser device, performs ablation monitored by medical device in real-time. The fusion device will deliver great perspective between the ablation areas and critical anatomical landmarks such as: NVB, membranous urethra, etc. Patient is dismissed to the recovery room and discharged afterwards
Sponsors
Urological Research Network, LLC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Men between 50 and 65 years of age with a clinical diagnosis of prostate cancer with Low or Intermediate risk prostate cancer, and \<50% positive core rate by prostate lobe * Men older than 65 years of age with clinical diagnosis of prostate cancer \<50% positive core rate by prostate lobe * Absence of extra-capsular extension * Absence of seminal vesicle invasion * Absence of regional or distant metastatic disease * Multiparametric MRI of the prostate performed either before the biopsy or \>10 weeks after prostate biopsy * Treated with Cryotherapy of the prostate * Treatment based on co-registration between MP-MRI and Prostate Ultrasound
Exclusion criteria
* Prior treatment of prostate cancer in the form of surgery. * Performance status greater than 0 based on ECOG criteria * Mental status impairment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Oncological Control | 1 Year | Negative CANCER Rate in treated area after fusion biopsy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Perioperative Outcomes | 90 days | Rate of Adverse Events and Serious Adverse Events following CTCAE v5 classification |
| Urinary Function | 5 years | Rate of AUA symptoms score less than 7 (Scale 0-35). |
| Sexual Function | 5 years | Rate of Sexual Inventory for men scores above 15 (Scale 1-25) |
| Radiological Cancer Control | 5 Years | Rate of Detection of discrete lesions following multi-parametric prostate MRI |
Other
| Measure | Time frame | Description |
|---|---|---|
| Rate of Conversion to Whole gland treatment - Salvage Treatment | 10 years | Conversion to radical surgery or radiation or cryoablation |
| Rate of development of metastasis | 10 years | Detection of metastatic disease |
Countries
United States
Contacts
Primary ContactCIELO D GUERRA, BS
Backup ContactLUANDA SIANO, PA
Outcome results
None listed