Prostate Cancer Clinical Trial
— TPF-LITTOfficial title:
TRANBERG® Transperineal MR/US Focalyx Fusion Laser--Induced Thermal Therapy in the Office Setting Under Local Anesthesia
This study is set up as a phase I prospective, single center, device interventional pilot study carried in office setting under local anesthesia. It will assess the tolerance and safety of target fusion ablation of prostate cancer tumors using Laser Induced Thermal Therapy (TFA-LITT) guided by fusion imaging in men 50 to 80 years of age with low to intermediate risk prostate cancer Prostate Cancer is currently managed with in a discrete fashion where patients either enroll in active surveillance protocols (No intervention) or undergo full intervention via whole gland treatments - most commonly radical surgery or radiation. These treatments have not shown definitive gains in all cause survival and not uncommonly harbor undesirable adverse effects, most notably: impotency and incontinence. Such events elicit significant and noticeable changes on a male lifestyle and for most prostate cancer tumors are considered overtreatment. This study aims to evaluate the use of TFA-LITT in the office setting under local anesthesia - greatly decreasing patient perioperative surgical risk - focused on the organ sparing cancer lesion ablation, where organ function is preserved. The fundamental objective is to determine the tolerance and safety of TFA-LITT in men with low to intermediate risk prostate cancer, successful performed in the outpatient office-based setting under local anesthesia directed by fusion imaging. Secondary objectives include: 1-Biopsy proven cancer control of ablated areas 12 months after procedure; 2-Uroflowmetry and urinary function Patient Reported Outcome Measures (PROMs) at one, three, six, nine and 12 months; 3- Sexual function Patient Reported Outcome Measures (PROMs) at one, three, six, nine and 12 months; 4- MRI changes of ablated area one, three and 12 months after TFA-LITT; 5- Absence or presence of ejaculation after TFA-LITT.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | January 30, 2033 |
Est. primary completion date | January 27, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 50 Years to 80 Years |
Eligibility | Inclusion Criteria: - Willing and able to sign informed consent - Subject is able and willing to complete all procedure and follow-up visits indicated in the protocol - Absence of urinary retention - Prostate volume: = 18 and = 100 cc, measured by transrectal ultrasound - Serum creatinine levels <2 ng/dl and GFR > 45 - Serum PSA levels < 20 ng/ml - Multiparametric prostate MRI with piRADS scores 3-5 - Prostate volume: = 18 and = 100 cc, measured by MRI - Presence of Intermediate risk prostate cancer with a volume that is less than 1/3 of the gland volume by MRI evaluation Exclusion Criteria: - Post-void residual (PVR): > 250 mL or > 50% of voided volume - Previous prostate cancer intervention (Radiation therapy, brachytherapy, prostate cryoablation - Major neurological conditions such as Alzheimer's, Parkinson, Multiple sclerosis, ALS, spinal cord injury - Evidence of neurogenic bladder determined by urodynamics studies - Presence of Indwelling Foley catheter or on active regime of clean intermittent catheterization (CIC) in the prior 30 days - Active urinary tract infection determined by urinary cultures - SHIM score <14 - IPSS score >23 - Acute prostatitis - Macroscopic hematuria without a known contributing factor - History of colorectal carcinoma with anterior perineal resection of rectum - History of pelvic radiation therapy or radical pelvic surgery - History of bladder neck contracture and/or urethral strictures within the 5 years prior to the informed consent date - Bladder stones - Medical contraindication for undergoing TPFLA surgery (eg, infection, coagulopathy, significant cardiac or other medical risk factors for surgery) - Diagnosed or suspected bleeding or coagulopathic disorder such as hemophilia, ITP, TTP - Medical contraindication to being subjected to local anesthesia |
Country | Name | City | State |
---|---|---|---|
United States | Urology Specialist Group | Hialeah | Florida |
Lead Sponsor | Collaborator |
---|---|
Urological Research Network, LLC |
United States,
Al-Hakeem Y, Raz O, Gacs Z, Maclean F, Varol C. Magnetic resonance image-guided focal laser ablation in clinically localized prostate cancer: safety and efficacy. ANZ J Surg. 2019 Dec;89(12):1610-1614. doi: 10.1111/ans.15526. Epub 2019 Nov 3. — View Citation
Bianco FJ, Martinez-Salamanca JI. Focalyx Dx, Bx, Tx et Apps: A novel contemporary fusion paradigm for the management of prostate cancer. Arch Esp Urol. 2016 Jul;69(6):353-63. — View Citation
Carter G, Clover K, Britton B, Mitchell AJ, White M, McLeod N, Denham J, Lambert SD. Wellbeing during Active Surveillance for localised prostate cancer: a systematic review of psychological morbidity and quality of life. Cancer Treat Rev. 2015 Jan;41(1):46-60. doi: 10.1016/j.ctrv.2014.11.001. Epub 2014 Nov 13. — View Citation
Cooley LF, Emeka AA, Meyers TJ, Cooper PR, Lin DW, Finelli A, Eastham JA, Logothetis CJ, Marks LS, Vesprini D, Goldenberg SL, Higano CS, Pavlovich CP, Chan JM, Morgan TM, Klein EA, Barocas DA, Loeb S, Helfand BT, Scholtens DM, Witte JS, Catalona WJ; Collaborators. Factors Associated with Time to Conversion from Active Surveillance to Treatment for Prostate Cancer in a Multi-Institutional Cohort. J Urol. 2021 Nov;206(5):1147-1156. doi: 10.1097/JU.0000000000001937. Epub 2021 Sep 10. — View Citation
Cooperberg MR, Carroll PR, Klotz L. Active surveillance for prostate cancer: progress and promise. J Clin Oncol. 2011 Sep 20;29(27):3669-76. doi: 10.1200/JCO.2011.34.9738. Epub 2011 Aug 8. — View Citation
Hamdy FC, Donovan JL, Lane JA, Mason M, Metcalfe C, Holding P, Davis M, Peters TJ, Turner EL, Martin RM, Oxley J, Robinson M, Staffurth J, Walsh E, Bollina P, Catto J, Doble A, Doherty A, Gillatt D, Kockelbergh R, Kynaston H, Paul A, Powell P, Prescott S, Rosario DJ, Rowe E, Neal DE; ProtecT Study Group. 10-Year Outcomes after Monitoring, Surgery, or Radiotherapy for Localized Prostate Cancer. N Engl J Med. 2016 Oct 13;375(15):1415-1424. doi: 10.1056/NEJMoa1606220. Epub 2016 Sep 14. — View Citation
Hu Y, van den Boom R, Carter T, Taylor Z, Hawkes D, Ahmed HU, Emberton M, Allen C, Barratt D. A comparison of the accuracy of statistical models of prostate motion trained using data from biomechanical simulations. Prog Biophys Mol Biol. 2010 Dec;103(2-3):262-72. doi: 10.1016/j.pbiomolbio.2010.09.009. Epub 2010 Sep 30. — View Citation
Kasivisvanathan V, Rannikko AS, Borghi M, Panebianco V, Mynderse LA, Vaarala MH, Briganti A, Budaus L, Hellawell G, Hindley RG, Roobol MJ, Eggener S, Ghei M, Villers A, Bladou F, Villeirs GM, Virdi J, Boxler S, Robert G, Singh PB, Venderink W, Hadaschik BA, Ruffion A, Hu JC, Margolis D, Crouzet S, Klotz L, Taneja SS, Pinto P, Gill I, Allen C, Giganti F, Freeman A, Morris S, Punwani S, Williams NR, Brew-Graves C, Deeks J, Takwoingi Y, Emberton M, Moore CM; PRECISION Study Group Collaborators. MRI-Targeted or Standard Biopsy for Prostate-Cancer Diagnosis. N Engl J Med. 2018 May 10;378(19):1767-1777. doi: 10.1056/NEJMoa1801993. Epub 2018 Mar 18. — View Citation
Lee T, Mendhiratta N, Sperling D, Lepor H. Focal laser ablation for localized prostate cancer: principles, clinical trials, and our initial experience. Rev Urol. 2014;16(2):55-66. — View Citation
Loeb S, Carter HB, Schwartz M, Fagerlin A, Braithwaite RS, Lepor H. Heterogeneity in active surveillance protocols worldwide. Rev Urol. 2014;16(4):202-3. No abstract available. — View Citation
Simmons LAM, Kanthabalan A, Arya M, Briggs T, Barratt D, Charman SC, Freeman A, Gelister J, Hawkes D, Hu Y, Jameson C, McCartan N, Moore CM, Punwani S, Ramachandran N, van der Meulen J, Emberton M, Ahmed HU. The PICTURE study: diagnostic accuracy of multiparametric MRI in men requiring a repeat prostate biopsy. Br J Cancer. 2017 Apr 25;116(9):1159-1165. doi: 10.1038/bjc.2017.57. Epub 2017 Mar 28. — View Citation
Walser E, Nance A, Ynalvez L, Yong S, Aoughsten JS, Eyzaguirre EJ, Williams SB. Focal Laser Ablation of Prostate Cancer: Results in 120 Patients with Low- to Intermediate-Risk Disease. J Vasc Interv Radiol. 2019 Mar;30(3):401-409.e2. doi: 10.1016/j.jvir.2018.09.016. — View Citation
* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of TRANBERG® TPF-LITT performed in the office setting under local anesthesia. | Tolerability will be assessed during the execution of TFP-LITT at several phases of the treatment. An analog pain scale will be provided to the patient, whom will be asked to describe any pain scores at each of the following treatment successions:
superficial perineal block, foley advancement, deep perineal block, fusion co-registration, before and after each ablation, 6-Once the patient has recovered, he will be asked for an overall pain assessment. Safety will be evaluated by assessments of the 7-day, 30-day and 90-day AEs reported using the CTCAE scale, as perioperative assessments will be conducted at each of these milestones. A grade 3 or worse AEs based on the CTCAE v5.0 within 90 days post procedure will be considered severe. Any registered AEs will be labelled as follows: Not related Possible Probable Causal relationship |
90 days | |
Secondary | Average Ablated area volume (in cc) measured by MRI immediately following the procedure | patients will undergo a multiparametric MRI immediately after the procedure and the ablated areas will be contoured and the dimensions on cubic centimeters will be recorded as ablation area | 24-72 hours after procedure | |
Secondary | Average Ablated area volume (in cc) measured by MRI 1-month following the procedure | patients will undergo a multiparametric MRI 30 days (1-month) after the procedure and the ablated areas will be contoured and the dimensions on cubic centimeters will be recorded as ablation area | 30 days | |
Secondary | Average Ablated area volume (in cc) measured by MRI 3-month following the procedure | patients will undergo a multiparametric MRI 90 days (3-month) after the procedure and the ablated areas will be contoured and the dimensions on cubic centimeters will be recorded as ablation area | 90 days | |
Secondary | Average Ablated area volume (in cc) measured by MRI 1-year following the procedure | patients will undergo a multiparametric MRI 1-year after the procedure and the ablated areas will be contoured and the dimensions on cubic centimeters will be recorded as ablation area | 1 year | |
Secondary | Number of patients with a 75% decrease in Serum PSA levels (ng/ml) after procedure measured at fixed intervals | The PSA will be obtained as well at 1, 3, 6, 9 and 12-months post procedure. | 1 year | |
Secondary | Number of patients with presence of cancer cells in treated -ablated- area | pathological assessment of samples obtained trough a MR/US Transperineal Fusion biopsy of the prostate treated area | 1 year | |
Secondary | Number of patients with a 50% increase in qMAX measured in cc/second on flow studies | Uroflowmetry in cc/s will be performed on patients at 3 and 12 months after the procedure. Assessment of maximal flow rate -qmax (cc/seconds) will be obtained | 12 Months | |
Secondary | Number of patients with a 7 point drop in the International Prostate Symptom Score (IPSS) | Patients will be asked to answer the validated questionnaire - international prostate symptom scores (IPSS) - at 1,3 ,6 ,9 and 12 months following the procedure The IPSS scores range from 1 to 35 | 12 Months | |
Secondary | Number of patients with a 5 point drop in the sexual health inventory for men (SHIM) scores | Patients will be asked to answer the validated questionnaire - sexual health inventory for men (SHIM) - at 1,3 ,6 ,9 and 12 months following the procedure The SHIM scores range from 1 to 25 | 12 Months | |
Secondary | Number of men with absent ejaculation | Assessed by a direct yes or no answer to the question at 1,3 ,6 ,9 and 12 months following the procedure | 12 Months |
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