Clinical trial NCT02381990: MRI/Ultrasound Fusion Guided Prostate Cryotherapy
Official title: Office Based MRI/Ultrasound Guided Prostate Cryotherapy: Outcomes Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Neoplasms Prostate
Cancer of the Prostate
Keywords: Prostate
PSA
FUSION
Ultrasound
MRI
Cancer
Cryotherapy
Outcomes
Recurrence
QOL, Quality of Life
Urinary function
Sexual Function
Lead sponsor: Urological Research Network, LLC
Sponsor class: OTHER
First posted: 2015-03-06
Enrollment: 5000
Sex: MALE
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: As written in Initial Section

Brief summary: Registration of Prostate Cancer patients undergoing Prostate Cryotherapy guided by Mutiparametric-MRI (MP-MRI) highlighting biopsy confirmed regions. The primary outcome measure is 5 year oncological control. Secondary aim is lack of progression beyond the prostate gland. The aim of intervention is to eradicate prostate cancer disease in the treated area while imposing no or minimal deleterious effects in quality of life.

Detailed description: CLINICAL TRIAL OF OBSERVATION NATURE

PRIMARY OUTCOME

Cancer control of treated areas 5, 10, 15 years after intervention based on prostate biopsy of initial treated area, progression requiring conversion to radical prostate surgery or radiation or other forms of whole gland treatment (ej, HIFU), Metastatic Free survival: CT Scan and Bone Scans, Cancer-Specific and Overall Survival

SECONDARY OUTCOMES

Secondary Interventions focal interventions due to de-novo lesions. Focal or target therapy rescue with other technologies (ej HIFU); Short, Intermediate and Long-Term Urinary and Sexual Function changes in quality of life measured by validated inventories; Anxiety related to cancer and cancer control. Treatment tolerance to local anesthesia. Patient App compliance and activity to monitor care

DATA COLLECTION

* Complete H\&P, family history, past medical and surgical history, social history, allergies, and medications
* As of July 2016, voluntary measurement thru Focalyx App for smartphones and tablets
* Imaging Specifics Assessing Prostate, Seminal Vesicles and Urethral Contouring by Multi-parametric-MRI. Dominant lesions and secondary lesions contouring my MP-MRI.
* Procedure specific Co-Registration quality with ultrasound denoting quality
* Specific ablative description and digitalization of critical measures such as: ablation type (ej cryotherapy, equipment used) procedure, cryoprobes used, freeze/thaw cycles timing, temperatures at neurovascular bundles, denonvilliers fascia. Urethral warmer requirements
* Follow up information: 30 day perioperative outcomes (incidence of UTI, urinary retention, failure of local anesthetic, pain measures). 6 week, 3,6,9,12 month and then every 6 month measures of PSA, Testosterone levels, Urinary Function and Sexual Function inventories, Overall anxiety and regret related to diagnosis and treatment
* Uroflow and PVR measurements by 3 to 6 month of treatment
* MP MRI on a yearly basis, for years 2,3,4 after treatment, biopsy driven by new suspicious MRI findings
* MP MRI triggered by elevation in PSA velocity or PSA level 10% above diagnosis
* Transperineal Fusion Guided Prostate biopsy at 1st year - emphasis on treated areas, suspicious MRI areas
* Transperineal Fusion Guided Prostate biopsy at 5th year - emphasis on treated areas, suspicious MRI areas
* 5, 10, 15 Yr CT Scans, PET Scan/Bone Scan

SAFETY MEASURES

* Periodic evaluation of registry to ensure consistency in follow up
* Patient remainders of tests required

Eligibility criteria: Inclusion Criteria:

* Men between 55 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

Primary outcomes:
measure: Oncological Control
timeFrame: 1 Year
Secondary outcomes:
measure: Oncological Control
timeFrame: 1 Year
measure: Oncological Control
timeFrame: Yearly, up to 10 years
measure: Urinary Functional Outcomes
timeFrame: Every 3 months up to 24 months
measure: Perioperative Outcomes
timeFrame: 30 days
measure: Sexual Functional Outcomes
timeFrame: Every 3 months up to 24 months
Other outcomes:
measure: Secondary Treatment Requirement
timeFrame: Yearly, up to 10 years
Locations:
city: Miami Lakes
country: United States
facility: Urological Research Network
state: Florida
Study officials:
affiliation: UROLOGICAL RESEARCH NETWORK
name: FERNANDO J BIANCO, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UROLOGICAL RESEARCH NETWORK
name: EUSEBIO LUNA, MD
role: STUDY_DIRECTOR
affiliation: UROLOGICAL RESEARCH NETWORK
name: Isabel H Lopez, MD
role: STUDY_DIRECTOR
References:
citation: Moore CM, Kasivisvanathan V, Eggener S, Emberton M, Futterer JJ, Gill IS, Grubb Iii RL, Hadaschik B, Klotz L, Margolis DJ, Marks LS, Melamed J, Oto A, Palmer SL, Pinto P, Puech P, Punwani S, Rosenkrantz AB, Schoots IG, Simon R, Taneja SS, Turkbey B, Ukimura O, van der Meulen J, Villers A, Watanabe Y; START Consortium. Standards of reporting for MRI-targeted biopsy studies (START) of the prostate: recommendations from an International Working Group. Eur Urol. 2013 Oct;64(4):544-52. doi: 10.1016/j.eururo.2013.03.030. Epub 2013 Mar 20.
citation: Bahn D, de Castro Abreu AL, Gill IS, Hung AJ, Silverman P, Gross ME, Lieskovsky G, Ukimura O. Focal cryotherapy for clinically unilateral, low-intermediate risk prostate cancer in 73 men with a median follow-up of 3.7 years. Eur Urol. 2012 Jul;62(1):55-63. doi: 10.1016/j.eururo.2012.03.006. Epub 2012 Mar 21.
citation: Costa DN, Pedrosa I, Donato F Jr, Roehrborn CG, Rofsky NM. MR Imaging-Transrectal US Fusion for Targeted Prostate Biopsies: Implications for Diagnosis and Clinical Management. Radiographics. 2015 May-Jun;35(3):696-708. doi: 10.1148/rg.2015140058. Epub 2015 Mar 18.
citation: Barentsz JO, Richenberg J, Clements R, Choyke P, Verma S, Villeirs G, Rouviere O, Logager V, Futterer JJ; European Society of Urogenital Radiology. ESUR prostate MR guidelines 2012. Eur Radiol. 2012 Apr;22(4):746-57. doi: 10.1007/s00330-011-2377-y. Epub 2012 Feb 10.
citation: Siddiqui MM, Rais-Bahrami S, Turkbey B, George AK, Rothwax J, Shakir N, Okoro C, Raskolnikov D, Parnes HL, Linehan WM, Merino MJ, Simon RM, Choyke PL, Wood BJ, Pinto PA. Comparison of MR/ultrasound fusion-guided biopsy with ultrasound-guided biopsy for the diagnosis of prostate cancer. JAMA. 2015 Jan 27;313(4):390-7. doi: 10.1001/jama.2014.17942.