Micro-ultrasound-Guided Focal Laser Ablation for Intermediate-Risk Prostate Cancer: Safety & Effectiveness

Official title

Micro-ultrasound-Guided Focal Laser Ablation (MicroUSgFLA) Treatment for Management of Intermediate-Risk Prostate Cancer: Evaluation of Safety and Effectiveness

Overview

This clinical research study is intended to show that Micro-Ultrasound Guided Focal Laser Ablation (MicroUSgFLA) is a safe procedure that can significantly postpone or eliminate the need for patients with intermediate-Risk prostate cancer (PCa) to undergo a definitive treatment (i.e., Radical Prostatectomy or Radiation Therapy) for their disease.

Detailed description

Prostate cancer is the most common cancer in men, and a large proportion of these diagnoses are of the low or intermediate risk type that are amenable to a minimally invasive approach to treatment such as Focal Therapy. If successful, this study will show that trans-perineal interstitial laser focal therapy of the prostate could be offered over a wider community setting than only at a major hospital as an Magnetic Resonance Imaging (MRI), to confidently locate the Index Lesion would not be required because MicroUS is showing the same potential to visualize the lesion. MicroUS-guided focal laser ablation would be a simpler treatment than the complexity required under MRI, it could be offered in communities that might not have local access to MRI facilities and could be offered to individuals who are contra-indicated for MRI for such reasons as having metallic implants or severe claustrophobia.

Interventions

• Procedure 6 month, prospective, interventional single-arm safety and effectiveness study
  x
• Device The TRANBERG|CLS Thermal therapy
  Micro Ultrasound Guided Focal Laser Ablation of Prostate Cancer by The Diode Laser System - The TRANBERGCLS\|Thermal Therapy

Primary outcome measures

• Primary Outcome 1: [Time frame: From enrollment to the end of treatment at 6 months.]
• Primary Outcome 2: Technical Success Rate of MicroUS-gFLA [Time frame: From enrollment to the end of treatment at 6 months]

Secondary outcome measures (3)

• Secondary Outcome 1 - Change in PSA Level From Baseline [Time frame: From enrollment to the end of treatment at 6 months.]
• Secondary Outcome 2: Change in Urinary Function (IPSS Score) [Time frame: From enrollment to the end of the treatment at 6 months]
• Secondary Outcome 3: Change in Erectile Function (IIEF-15 Score) [Time frame: From enrollment to the end of treatment at 6 months]

Eligibility criteria

Inclusion criteria

• Men 40-80 years of age.
• Histologically-proven intermediate-risk PCa (Gleason score 7, primary grade ≤ 4).
• PCa clinical stage T1c or T2.
• MRI/MicroUS site suspicious for cancer or cancer mapped to one prostate lobe.
• Maximum dimension of MRI/MicroUS visible tumour ≤15mm.
• Suspicious site on Prostate MRI/MicroUS must coincide with sector positive for cancer on biopsy.
• Prostate specific antigen (PSA) level < 15 ng/mL.
• IPSS, ICIQ-UI-SF, IIEF-15 questionnaires completed prior to the procedure.
• Life expectancy of greater than 10 years, based on co-morbidity not related to PCa.

Exclusion criteria

• Maximum dimension of MRI/MicroUS visible tumour > 15 mm.
• Patients medically unfit for focal therapy of the prostate.
• Patients who are unwilling or unable to give informed consent.
• Patients who have received androgen suppression therapy.
• Patients who have received or are receiving chemotherapy for prostate carcinoma.
• Patients previously treated with surgery to the prostate (traditional, endoscopic or minimally invasive) including HIFU, TUNA, RITA, microwave, cryotherapy or any curative treatment.
• Patients who have undergone radiation therapy for PCa or to the pelvis.
• Any condition or history of illness or surgery that, in the opinion of the Investigator, might confound the results of the study or pose additional risks to the patient (e.g. significant cardiovascular conditions or allergies).
• Patients with a history of non-compliance with medical therapy and/or medical recommendations.
• Patients who are unwilling or unable to complete the patient self-assessment questionnaires.
• Chronic or acute prostatitis, neurogenic bladder, urinary tract infection, sphincter abnormalities, or any other symptom that prevents normal micturition.
• Patients who have participated in a clinical study and/or received treatment with an investigational treatment and/or product within the past 90 days.
• Patients with contraindication to MRI (i.e. pacemaker, hip prosthesis, severe claustrophobia, brain aneurysm clip, allergy to MRI contrast agent)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Canada · 1 center

• University Health Network - Princess Margaret Cancer Centre — Toronto

Publications

• Thompson IM, Pauler DK, Goodman PJ, Tangen CM, Lucia MS, Parnes HL, Minasian LM, Ford LG, Lippman SM, Crawford ED, Crowley JJ, Coltman CA Jr. Prevalence of prostate cancer among men with a prostate-specific antigen level < or =4.0 ng per milliliter. N Engl J Med. 2004 May 27;350(22):2239-46. doi: 10.1056/NEJMoa031918. PMID 15163773
• Thompson IM, Goodman PJ, Tangen CM, Lucia MS, Miller GJ, Ford LG, Lieber MM, Cespedes RD, Atkins JN, Lippman SM, Carlin SM, Ryan A, Szczepanek CM, Crowley JJ, Coltman CA Jr. The influence of finasteride on the development of prostate cancer. N Engl J Med. 2003 Jul 17;349(3):215-24. doi: 10.1056/NEJMoa030660. Epub 2003 Jun 24. PMID 12824459
• Wenger H, Yousuf A, Oto A, Eggener S. Laser ablation as focal therapy for prostate cancer. Curr Opin Urol. 2014 May;24(3):236-40. doi: 10.1097/MOU.0000000000000044. PMID 24625427
• Lindner U, Lawrentschuk N, Weersink RA, Davidson SR, Raz O, Hlasny E, Langer DL, Gertner MR, Van der Kwast T, Haider MA, Trachtenberg J. Focal laser ablation for prostate cancer followed by radical prostatectomy: validation of focal therapy and imaging accuracy. Eur Urol. 2010 Jun;57(6):1111-4. doi: 10.1016/j.eururo.2010.03.008. Epub 2010 Mar 12. PMID 20346578
• Lindner U, Weersink RA, Haider MA, Gertner MR, Davidson SR, Atri M, Wilson BC, Fenster A, Trachtenberg J. Image guided photothermal focal therapy for localized prostate cancer: phase I trial. J Urol. 2009 Oct;182(4):1371-7. doi: 10.1016/j.juro.2009.06.035. Epub 2009 Aug 14. PMID 19683262
• Peters RD, Chan E, Trachtenberg J, Jothy S, Kapusta L, Kucharczyk W, Henkelman RM. Magnetic resonance thermometry for predicting thermal damage: an application of interstitial laser coagulation in an in vivo canine prostate model. Magn Reson Med. 2000 Dec;44(6):873-83. doi: 10.1002/1522-2594(200012)44:63.0.co;2-x. PMID 11108624
• Guillaumier S, Peters M, Arya M, Afzal N, Charman S, Dudderidge T, Hosking-Jervis F, Hindley RG, Lewi H, McCartan N, Moore CM, Nigam R, Ogden C, Persad R, Shah K, van der Meulen J, Virdi J, Winkler M, Emberton M, Ahmed HU. A Multicentre Study of 5-year Outcomes Following Focal Therapy in Treating Clinically Significant Nonmetastatic Prostate Cancer. Eur Urol. 2018 Oct;74(4):422-429. doi: 10.1016/j PMID 29960750
• Alibhai SM, Naglie G, Nam R, Trachtenberg J, Krahn MD. Do older men benefit from curative therapy of localized prostate cancer? J Clin Oncol. 2003 Sep 1;21(17):3318-27. doi: 10.1200/JCO.2003.09.034. PMID 12947068

Identifiers

NCT: NCT07339943 · 21-6189

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗